Report On in Plant Training Final

REPORT ON
IN-PLANT TRAINING PROGRAMME IN

BIOPHARMA LIMITED
Duration of Training
06th February 2024 To 17th February 2024
Submitted To
Dr. Md. Golam Moula
DGM, Head of HR and Administration
BIOPHARMA Limited
Submitted by
Sl. No. Name of Trainee Reg. No. Institute
01 Habiba Rahman 17203032 University of Asia Pacific
02 Anindita Mitra Hridy 19203025 University of Asia Pacific
03 Khandakar Afia Amina 19203038 University of Asia Pacific
04 Nishkriti Sarker 19203043 University of Asia Pacific
05 Khairatun Hesan 19203044 University of Asia Pacific
06 Fatema Tuzz johura Mumu 191-29-1460 Daffodil International University
07 Sanjida Rahman 191-29-1447 Daffodil International University
Date of submission
March 13, 2024
Preface
We are the students of the Department of Pharmacy of University of Asia Pacific and Daffodil
International University had got the opportunity to complete my training session in Biopharma
Limited. Pharmacists are the most important human resources for pharmaceutical industries.
In-plant training in any pharmaceutical industry is considered as a part of B. Pharm (Hon’s)
course because practical experience makes a man or women perfect to his or her respective
profession. Realizing this fact to achieve such practical knowledge.
Since Biopharma Limited is one of the fast-growing pharmaceutical companies in Bangladesh

and have maximum market product. I am pleased to say that I have completed my 8 days in-
plant training in Biopharma Limited. During this training I observed different areas such as
production and packaging area, quality control and microbiology department, quality assurance
department, product development department, engineering section and warehouse and
inventory. We also gathered knowledge about administration, production planning, product
management department, new product launch procedure etc.
We hope Biopharma Limited will be able to achieve its mission and vision.
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Acknowledgement
All praises are for almighty Allah who has given us the ability to complete our training session
and opportunity to study in this subject.
It is our great pleasure and proud privilege to express our deep sense of gratitude to the authority
of University of Asia Pacific and Daffodil International University for providing us with the
training facility in the factory. In this context we would like to express our gratitude to all the
workers too for their excellent support to us during this period of in plant training.
Thank You
Habiba Rahman
Anindita Mitra Hridy
Khandakar Afia Amina
Nishkriti Sarker
Khairatun Hesan
Fatema Tuzz johura Mumu
Sanjida Rahman
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Executive Summary
There are several industries that are growing very fast in Bangladesh. Among them
pharmaceutical sector is one. For the last few years Bangladesh has earned a lot of foreign
exchange by exporting drugs throughout the world. In addition, Bangladesh is now self-
dependent in this sector. To carry on this envelopment the drug act was first published in 1982.
The ultimate result of this set is that now-a-days Bangladesh is the most promising country
among the least developing countries in this sector.
BIOPHARMA Ltd. is very much faithful to the country in this purpose. BIOPHARMA Ltd,
started its operation in Bangladesh in 1999, has now I grown to become the nation’s one of the
leading pharmaceutical companies. BIOPHARMA manufactures a range of dosage forms
including tablets, capsules, dry syrup, syrup, suspension, powder for suspension, cream,
ointment etc.
BIOPHARMA is the largest exporter of pharmaceuticals from Bangladesh in developing

countries, such as Myanmar, Kenya, Afghanistan, Srilanka etc.
Technology carries the promise of tomorrow. The benefits of technology belong to all of us
benefits of that create new opportunities and open doors to a better. The BIOPHARMA has
been designed in a way to ensure highest-possible quality at every stage of manufacturing and
quality control. World-class facilities are being employed in each and every step including
mixing, filling, labeling, batch and other procedures to ensure manufacturing of world class
products.
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Special thanks to the following persons
Specially we express our appreciation to -
Md. Abul Bashar (General Manager, Plant)
Nesar Ahmmed (Deputy Manager, HR and Admin)
Abu Saleh Akram (Asst. Manager HR and Admin )
Sheikh Arif Hasan (Assistant Manager, QA)
Md. Hafizur Rahman (Senior Deputy Manager, Production)
Md. Zahidul Islam Khan (Senior Assistant Manager, Production)
Md. Jobaer Alam (Assistant Manager, Production)
Farooque Ahmed Bhuiyan (Sr. Manager, QC)
Md. Masudur Rahman (Assistant Manager, PD)
Md. Mostafizur Rahman (Senior Assistant Manager, Engineering)
Md. Mobarak Hossain (Manager, PPIC & IC)
Our deepest thanks to all section in charge, Officer, Supervisor, Workers in all department for
their respective cooperation and valuable guidance which help us to enrich us Pharmaceutical
practical knowledge that will help us for future improvement.
Truly we felt an extreme happiness for getting a training opportunity in BPL and we are pleased
for the compassionate behavior of all executives and workers.
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Objective of Our Internship
For the last four years, we went through several courses in pharmacy to complete our
graduation. We studied many topics and matters, but we would not see their implications in
pharmaceutical industries. So, our objectives are-
➢ To see and understand how a pharmaceutical company runs, how to differentiate
departments.
➢ To know how GMP or cGMP is applied in the plant.
➢ To know about SOP.
➢ To know how pharmacists solve manufacturing problems.
➢ To know how quality is assured as well as controlled.
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Biopharma Limited at a glance
Biopharma Limited, one of the fast-growing pharmaceutical companies in Bangladesh,
has been manufacturing and marketing a wide range of pharmaceutical finished
products with strict standard of safety, quality and efficacy to ensure public healthcare
thought uncompromising scientific and professional approach since 1999. The
company has sailed its journey with the involvement of a group of physicians, inspired
with love for mankind, with innovative mission and global conception and ethical
practice in pharmaceutical sector of Bangladesh.
Biopharma Limited is always committed to assure the best quality pharmaceutical

products and best services to the customers. The company mission is to serve the
mankind, especially the distressed and poor ailing people and our vision is to be
regarded globally as a Quality pharmaceutical manufacturer through the best quality
pharmaceutical products. Bearing this in mind, their technical experts (pharmacist,
Chemists, Biochemists, Microbiologists Analysts and other professionals) skilled and
trained staffs always try to leave no stone unturned in their professional works by
following the US cGMP, British & WHO GMP guidelines and the guidelines &
instructions of the Drug Administration & Licensing A authority of Bangladesh to
ensure the production of quality medicine. Ever since Biopharma Limited at GLP
(Good Laboratory practices) have always been performing with a strict discipline to
follow the company professional ethics. By virtue of the highest quality of drugs, the
company has already obtained the confidence and trust of doctors and patients all over
Bangladesh and earned excellent reputations in the market through introducing very
exciting new molecules and dosage forms in many therapeutic areas.
Biopharma Limited are now producing a wide range of Biological and pharmaceutical
products in different dosage forms and presentations including tablets, capsules, syrups,
suspensions, powder for suspensions, pediatric drops, sterile creams & ointments and
inject able preparations.
Head Office Plant

BIOPHARMA Ltd.
Biopharma Corporate Office BIOPHARMA Ltd.
House no: Road no: 01, Dhaka Housing Limited, 116/A, BSCIC Area,
Ring Road, Dhaka Tongi, Gazipur, Bangladesh
Fax: 88-02-9134684
Cell: +8801713043340
E-mail: b.pharma@aitlbd.net
Web: www.biopharmabd.com.
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Contents
No. Area of observation Page No.

1. Preface 1-8
2. HR& Administration Department 09
3. Quality Assurance Department 10-19
4. Product Development Department 20-23
5. Production Department 24
5.(i)Tablet processing
5.(ii)Liquid processing
5.(iii)Cream & Ointment processing 25-52
5.(iv)Dry syrup & Capsule
6. Quality Control Department 53-66
6.(i) Microbiology Unit
7. Warehouse & Inventory Control Department 67-70
8. Engineering Department 71-73
9. Finished Product of Biopharma Ltd. 74-75
10. Product of Biopharma Ltd. 76-79
11. Suggestions 80
12. Conclusion 81
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List of Abbreviation
Term Elaboration
BMR Batch Manufacturing Record
BPR Batch Packing Record
SOP Standard Operating Procedure
IHS In House Specification
QSP Quality System Procedure
WIP Software Based Work In Procedure
MRN Material Receiving Note
BOM Bill Of Materials
GMP Good Manufacturing practice
cGMP Current Good Manufacturing practice
LOD Loss On Drying
ETP Effluent Treatment Plant
RMG Rapid Mixing Granulator
FBD Fluidized Bed Dryer.
COA Certification Of Analysis
IC Inventory Control
PPIC Production Planning and Inventory Control
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HR& Administration Department
HR and administration are concerned with managing business operations and, consequently,
with making and carrying out important choices. The universal process of effectively allocating
resources and people to steer operations towards shared goals and objectives is known as
administration.
In BIOPHARMA Ltd, administrative head is the factory’s Deputy Manager Operations
himself.
Administrative Functions:
This department's primary goal is to maintain the smooth operation of the plant by carrying out
the following duties:
➢ Recruitment of people with the necessary training and expertise to occupy all positions
that impact quality. Various standards are taken into account depending on the role.
➢ Help new hires finish their onboarding tasks and make sure they are placed.
➢ To set up an orientation and induction-training programme for new hires. Each
employee is given an overview of the company's operations and each department after
joining.
➢ Assemble and oversee an internship programme for university students.
➢ Organise and update each employee's personal file once a month. The employee file is
updated with information such as confirmation of work augmentation, promotion,
transfer, and other letters.
➢ Oversee and track the monthly attendance of your staff. Job cards, daily absentee
reports, and monthly attendance summaries, among other things.
➢ Monitor & update leaves of plant employees. Each employees has a leave file which
integrated the all kinds of leaves.
➢ Inform management and staff about the company's personnel policies and procedures.
➢ Coordinate & monitor performance appraisal of plants employees annually.
➢ Determine the staff's training requirements in light of cGMP and other work-related
concerns.
➢ Deals with matters pertaining to the workplace, such as protecting workers' rights and
negotiating with unions.
➢ Make sure that labour rules that affect factory workers are properly implemented.
➢ Disciplinary measures, including as penalty, suspension, and termination.
➢ Maintain a positive labor-management relationship to facilitate efficient output.
➢ Maintain communicating with government regulatory agencies.
➢ Ensure safety of all employees & company assets
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Quality Assurance Department
Assigned person,
Sheikh Arif Hasan (Assistant Manager, QA)
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Introduction:
In pharmaceutical market the few companies that give quality product, Biopharma is one of
them. Now a days manufacturing of quality product is quite difficult. From the raw material to
the finished product in each and every step quality operation department plays a very important
role.
Quality Assurance Department:

The pharmaceutical industry is one of the most regulated activity sectors, where regulation
includes specific quality systems such as good laboratory practice (GLP), good clinical practice
(GCP) and good manufacture practice (GMP).
Quality Assurance (QA), is the activity of providing evidence needed to establish quality in
work, and that activities that require good quality are being performed effectively all those
planned or systematic actions necessary to provide enough confidence that a product or service
will satisfy the given requirements for quality. QA introduces the rules—'fit for purpose' and
'do it right the first time'. It can be achieved by introducing appropriate standard operating
procedures (SOPs) in-house.
Quality assurance is a wide ranging concept covering all matters that individually or
collectively influence the quality of a product.
QA is the heart and soul of quality control
QA = QC + GMP
The Quality Assurance Department is vital for a pharmaceutical industry since it controls and
assures the quality of the products starting from the raw materials.
Branch of QA:
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Functions of Quality Assurance Department:
1) Vender evaluation
2) Raw Material Analysis
3) In Process Analysis
4) Packaging Material Analysis
5) Finished Goods Analysis
6) Calibration and validation of Laboratory Instruments
7) Fixation of Expiration Date (Stability test)
8) Process Validation
9) Product Complained analysis
10) Investigation of Out of specification
11) GMP Audit
12) New source approval
13) Raw material validation
14) Microbiological Analysis
15) Development of new SOP (Standard Operating Procedure) for analysis.
The In-process duty of QA department is

• Total Monitoring in Production Area
• Documentation and Retention
• Approving the Production
• Approval
• Self inspection
• Auditing
In Process Control-
A check performed during production in order to monitor and if necessary to adjust processes
to ensure that the product conforms to its defined specification. The control of the environment
or equipment many also be regarded as a part of in process control. In-process check is required
to ensure product quality during manufacturing.
The in-process control are as follows-
A. Granulation
1. Appearance
2. LOD.
B. Compression:
1. Appearance.
2. Average wt.
3. Uniformity of wt.
4. Friability test.
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5. DT test.
6. Diameter.
7. Thickness.
8. Temperature.
9. Relative humidity.
C. Coating:
1. Appearance.
2. Average wt.
4. Temperature.
D. Packaging:
1. Batch No.
2. Mfg date.
3. Exp date.
4. Leak test.
5. Temperature.
2. CAPSULE-
A. Encapsulation:
1. Appearance.
2. Average wt.
4. Temperature.
6. DT test.
B. Packaging:
1. Batch No.
2. Mfg No.
3. Exp date.
4. Temperature.
3. POWDER FOR SUSPENSSION-
A. Granulation and blinding:
1. Appearance.
2. LOD
3. Filling wt.
4. Temperature.
B. Packaging:
1. Batch No.
2. Mfg No.
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3. Exp date.
4. Temperature.
4. SEMISOLID AND SUPPOSITORY-
A. Preparation:
1. Appearance.
2. LOD
3. Filling wt.
4. Temperature.
B. Packing:
1. Batch No.
2. Mfg No.
3. Exp date.
4. Temperature.
5. ORAL LIQUID:
A. Preparation:
1. Appearance.
2. PH.
3. Filling wt.
4. Temperature.
B. Packaging:
1. Batch No.
2. Mfg No.
3. Exp date.
6. VIALS:
A. Preparation:
1. Appearance.
2. Particle count.
3. Filling wt.
4. Temperature.
B. Packaging:
1. Batch No.
2. Mfg No.
3. Exp date.
7. AMPOULES:
A. Preparation:
1. Appearance.
2. Particle count.
3. Filling wt.
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4. Temperature.
B. Packaging:
1. Batch No.
2. Mfg No.
3. Exp date.
One of the important responsibilities of Quality Assurance Department is the sampling of the
incoming materials. The flow chart of this process is given below-
Flow Chart of Sampling of Incoming Materials:

Receiving the MRN (Material Receiving Note from warehouse
Take MRN & go to the warehouse with sampling equipment & container
Check visually each container/box/packet
Make a sampling plan
Clean the selected container/box/packets
Collected sample from each selected containers/boxes/packets
Affin “Sampled Tag” & “Under Test Tag” on those

Containers/boxes/packets in which samples are taken.
Validation
The documented act of proving that any procedure, process, equipments, material activity or
system actually leads to the expected results. It is an integral part of Quality Assurance.
Attention to be accorded to
• Procedure
• Process
• Machine
• System
• Clearing
For validation, Validation protocol and Validation master plan are essential. Validation may
be beneficial for the manufacture in this way:
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• It depends the under standing of process, decreases the risk processing.
• It decreases the risk of costs.
• It decreases the risk of cost.
• It decreases the regulatory non-compliance.
• A fully validated process may require less in-process control and end product
testing.
Process Validation:
Establishing documented evidence which provides a high degree of assurance that a specific
process will consistently produce a product meeting its predetermined specifications and
quality attribute. According to FDA process validation is two types:
1. Prospective process validation.
2. Retrospective process validation.
1. Prospective process validation: Validation conducted prior to the distribution of a new

product or product made under a revised manufacturing process, where the revision
may affect the products characteristics.
2. Retrospective process validation: Validation of a product already in distribution based
upon accumulated production, testing and data. According to cGMP process validation
is of three types.
* Prospective process validation: Carried out during development stage.
* Concurrent process validation: Carried out during normal production.
* Retrospective process validation: Involved the examination of post experience of
production on the assumption on accumulated production and control data.
Equipment Validation:
An equipment validation program can be described in four sequential phases:
• Pre qualification (under specification, design & operation check out)

• Qualification (installation and operational check out)
• Process qualification and performance qualification.
• On going evaluation or process validation.
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Installation qualification-Establishing confidence that the process equipment and ancillary
system are capable of consistently operating with in establishes limits and tolerance.
Operational qualification- Documented verification that the system or sub system performs a
intended over all anticipation operating range.
Process qualification- Establishing confidence that process is effective and reproducible.
Stability Study:
A study of the stability of pharmaceutical product is essential for three main reasons. Firstly it
is important from the point of view of the safety of patient Secondly consideration must be
given to the relevant legal requirements concerned with the identity, strength, purity, quality of
the drug. Finally such a study is important of prevent economic repercussions of marketing an
unstable product.
Stability study is done by two methods:
1. Accelerated storage test.
2. Storage test method.
Product Complaints:
A complaint from the market may indicate some sort of defect on the product, which may range
from a minor fault to one of serious consequence. Correct & prompt evaluation of the market
complaint is an important part of quality assurance function. Procedure needs to be establishing
to receive complaint & deal with them efficiently.
A complaint may originate from consumer, chemists, hospitals or wholesalers/warehouse. QA
Department the complaints through marketing. It is important that the complaint, investigation,
relevant corrective actions & reporting back to the marketing are quick. This will ensure
product quality as ell as establish a better consumer relation.
Product Recall:
A product recall is a process of withdrawing one or more batches or all of a certain product
from market distribution. A product recalls is institute following discovery of a quality defect
or if there is a report of serious adverse reaction of a drug product which may cause health risk.
Total withdrawal of a drug product from market distribution may result in suspension or
discontinuation of manufacturing of products.
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Self-Inspection:
The purpose of self-inspection is to evaluate the manufacturer’s compliance with GMP in all
aspects of production & quality control. The self-inspection program should be designed to
detect any shortcoming in the implementation of GMP and recommend the necessary
corrective action. Self-inspection should perform routinely, and may be, in addition, performed
on special occasion, e.g. in the case of product recalls repeated rejections or when an inspection
by the health authorities is announced. The team responsible for self-inspection should consist
of personnel who can evaluate the implementation of GMP objectively; all recommendations
for corrective action should be implemented. The procedure for self-inspection should be
documented and there should be an effective follow-up program.
Items of Self Inspection:

Written instrument for self-inspection should be established to provide a minimum & uniform
standard of requirements. These may include questionnaires on GMP requirements covering at
least the following items:
• Personnel.
• Premises including personnel facilities.
• Maintenance of buildings & equipments.
• Storage of starting materials & finished products.
• Equipments.
• Production & in-process control.
• Quality control.
• Documentation.
• Sanitation & revalidation program.
• Recall procedure.
• Complaints management.
• Label control.
• Result of previous self-inspection & any corrective steps taken.
Self-Inspection Team:
Management should appoint a team of self-inspection consisting of at list three members who
are expert in their own field & familiar with GMP. The member of the team may be appointed
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from inside or outside the company. Each member should be independent in performing the
inspection & evaluation.
Self-Inspection Report:
A report should be made at the completion of self-inspection. The report should included
following things:
• Self-inspection report.
• Evaluation & conclusion.
• Recommended corrective action.
During our implant training we saw the following product in QA.
Aceta-Tab. Batch-658
Bacifen -Tab.
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Product Development Department
Assigned person,
Md.Masudur Rahman (Assistant Manager, PD)
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Activities Done by Pd
Formulation of New Product:
➢ Pre-formulation study of the active ingredients, which includes collecting all available
information of the active regarding its formulation its formulation , physical,
chemical, therapeutical, toxicological, microbiological (if necessary) data.
➢ Trail of the product in small scale that includes the entire manufacturing procedure.
➢ Comparative study on market sample for newly developing product and for existing
product.
➢ Physical and chemical analysis of the newly developed products.
➢ Accelerated Stability Study of the new products.
➢ In case of INN products, raw material analysis and method development for
dissolution procedure.
➢ Process Validation of 3 consecutive batches.
➢ Stability & chemical analysis of the products those are included in compendia
(BP/USP) which often include HPLC analysis.
Reformulation of Existing Product:

➢ study on market complaint products to minimize complaint, which include-
➢ Root cause analysis of the complaint,
➢ Reformulation of the product,
➢ Trail,
➢ Chemical analysis and
➢ Stability.
➢ Shape change, coating color change or changing other parameters of any product that
includes reformulation of the product, trail chemical analysis and stability.
➢ Source evaluation of active ingredients and excipients that needs several trails for
individual product.
Documentation:
➢ BMR preparation of all new products.
➢ BMR of existing product dew to the batch size or other parameter.
➢ Stability data (accelerated and real time) preparation for export.
➢ Technical part of Recipe.
➢ Correction of Product Brief and Annexure.
➢ Process validation documentation.
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Steps of the development of a new product:
Step-1: Product information from marketing department along with
………..necessary attributes such as
- Source
- Sample
- Q.C test (potency. LOD etc)
Step-2: Pre-formulation study of the active drug and excipients.
- Chemical activity.
- Function.
- Interaction.
- Boiling point.
- Contraindication.
- Moisture content etc.
Step-3: Collection of raw materials of active drug and excipients.
Step-4: Different trials for development of a stable, effective and active

formulation.
Step-5: Drug administration formalities include:
a) Submission of recipe to drugs administration which contains -
- Strength
- Dosage form
- Contraindication
- Dissolution
- Description
- Precaution
- Side effect
- M.R.P.
- Indication
b) Sample admission (if INN product)
c) Approval of sample from drug administration and inclusion of
D.A.R. and license no.
d) Submission of Inclusion Dossier.
e) Final approval for commercial production.
Step-6: Pilot trial and accelerated stability testing.

Step-7: Readjustment If necessary.
Step-8: BPR preparation if every aspect is satisfied which contains
- Product name
- Code
- Size
- batch no
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- Theoretical yield
- Batch size
- Annexure etc.
Step-9: Transfer to production department commercial production.
Name of the Machinery:
➢ Universal motor drive.
➢ Fluid bed dryer.
➢ Tablet compression machine.
➢ Mixing M/C.
➢ Humidity chamber.
➢ Dry chamber.
➢ Friability tester.
➢ Roll compacter.
➢ Incubator.
➢ Light chamber.
➢ Disintegration tester.
➢ Unicoata-24.
➢ Rapid mixture granulator.
➢ Rotary tablet compression.
➢ Spectrophotometer.
➢ Multi mill.
During our implant training we saw the following product in PD.
Termider- Tab 250mg, from new source of raw material.
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Production Department
Assigned person,
Md. Hafizur Rahman (Senior Deputy Manager, Production)
Md. Zahidul Islam Khan (Senior Assistant Manager, Production)
Md. Jobaer Alam (Assistant Manager, Production)
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Tablet Processing Unit
Solid Section:
Solid dosage forms are among the most inexpensive, popular, and convenient methods of drug
delivery. They can be manufactured in a non-sterile environment, and the technology is well-
known after over a century of development. Because most pharmaceuticals are manufactured
in solid dosage forms, it is critical that the unit operations for their production be thoroughly
understood. This course covers the fundamentals of each discrete processing step (unit
operation) needed for the production and packaging of tablets and capsules, the most common
solid dosage forms.
Manufacturing Area
Tablet
A tablet is a solid formed by pressing or compacting active substances and excipients, which
are typically in powder form. Binders, glidants (flow aids), and lubricants are used to ensure
efficient tableting; disintegrants are used to break up the tablet in the digestive tract; sweeteners
or flavours are used to mask the taste of bad-tasting active ingredients; and pigments are used
to make uncoated tablets visually appealing. A polymer coating is typically applied to hide the
taste of the tablet's components, make the tablet smoother and easier to swallow, and increase
its resistance to the environment, thereby extending its shelf life.
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A Typical Tablet Contains
Tablet Excipients:
Antiadherents:
Antiadherents are used to reduce the adhesion between the powder (granules) and the punch
faces and thus prevent sticking to tablet punches. The most commonly used is magnesium
stearate.
Binders:
Binders hold the ingredients in a tablet together.
Binders allow tablets and granules to be formed with the necessary mechanical strength while
also providing volume to low active doses tablets. Starches, sugars, cellulose or modified
cellulose (such as microcrystalline cellulose, hydroxypropyl cellulose), lactose, or sugar
alcohols such as xylitol, sorbitol, or maltitol are common binder materials.
Disintegrants:
Disintegrants expand and dissolve when wet causing the tablet to break apart in the digestive
tract, releasing the active ingredients for absorption. Disintegrant types include:
1. Water uptake facilitators
2. Tablet rupture promoters
They ensure that when the tablet is in contact with water, it rapidly breaks down into smaller
fragments, thereby facilitating dissolution. Examples of disintegrants include: crosslinked
polyvinyl, sodium starch glycolate, crosslinkedcrosslinked sodium (crosscarmellose).
Fillers and diluents:

Fillers fill out the size of a tablet or capsule, making it practical to produce and convenient for
the consumer to use. By increasing the bulk volume, the fillers make it possible for the final
product to have the proper volume for patient handling.
Plant cellulose (pure plant filler) is popular filler in tablets or hard gelatin capsules. Dibasic
calcium phosphate is popular tablet filler. A range of vegetable fats and oils can be used in soft
gelatin capsules.
Other examples of fillers include: lactose, sucrose, glucose, mannitol, sorbitol, calcium
carbonate, and magnesium stearate.
Flavours:
Flavours can be used to mask unpleasant tasting active ingredients and improve the likelihood
that the patient will complete a course of medication. Flavourings may be natural (e.g. fruit
extract) or artificial.
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Colours:
Colours are added to improve the appearance of a formulation. Colour consistency is important
as it allows easy identification of a medication.
Glidants:
Glidants are used to promote powder flow by reducing interparticle friction and cohesion.
These are used in combination with lubricants as they have no ability to reduce die wall friction.
Examples include colloidal silicon dioxide, talc, and magnesium carbonate.
Lubricants:
Lubricants prevent ingredients from clumping together and from sticking to the tablet punches
or capsule filling machine. Lubricants also ensure that tablet formation and ejection can occur
with low friction between the solid and die wall.
Common minerals like talc or silica, and fats, e.g. vegetable stearin, magnesium stearate or
stearic acid are the most frequently used lubricants in tablets or hard gelatin capsules.
Sweeteners:
Sweeteners are added to make the ingredients more palatable, especially in chewable tablets
such as antacid or liquids like cough syrup. Therefore, tooth decay is sometimes associated
with cough syrup abuse. Sugar can be used to disguise unpleasant tastes or smells.
Tablet Production
In tablet production there are several steps involved which are following:
➢ Dispensing
➢ Weighing and dry mixing
➢ Wet mixing
➢ Dry mixing
➢ Final drying
➢ Lubrication
➢ Coating (if needed)
➢ Compression
➢ Secondary packaging
Granulation Unit
Granulation is a mechanical process used to change the physical properties of a powder or
powder blend. Flow characteristics, density, and particle size are the primary parameters
influenced by this process.Granulation processes are employed when the raw material powder
or blend exhibits behavior properties that hinder other manufacturing processes. All the
materials are received from the dispensing unit and granulation is performed. For suitable
granulation, it is required to have 30-40% powder and 60-70% granules and also 1-5% moisture
in compressing particles.
Purposes Of Granulation
1. To produce tablets of appropriate size.
2. To prevent segregation of the constituents in the powder mix.
3. To improve the flow properties of the powder mix.
4. To improve compression nature of powder.
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Types of granules
Two types of granules are produced in the four-granulation units of the industry, which include;
• Granules with active ingredient/s
• Placebo granules without any active ingredient/s for moisture sensitive active/s or
drug/s
There are three types of granulation process. Such as-

1. Wet Granulation.
2. Dry Granulation.
3. Direct compression
Wet granulation:
Wet granulation is a process of using a liquid binder or adhesive to the powder mixture. The
amount of liquid can be properly managed, and over wetting will cause the granules to be too
hard and under wetting will cause them to be too soft and friable. Aqueous solutions have the
advantage of being safer to deal with than solvents.
Flow Chart of Wet Granulation:

Weighing of active ingredient as well as excipients

Dry mixing

Paste mixing by addition of de-mineralized (DM) water or Maize starch paste in Rapid Mixer
Granulator (RMG) for a certain time period specified in the Batch Manufacturing Record
(BMR)

Initial Phase drying in Fluid Bed Dryer (FBD)

Milling in the Multimill

Partial drying in FBD

Milling in the Multimill

Terminal/Final drying in the FBD

Sieving in the Vibratory Sifter according to the required particle/granule size

Measurement of Loss on Drying (LOD)

Granules of desired size ready for blending with lubricants
28
Dry granulation
Dry granulation is the process of forming particles—i.e., granulates or granules—from dry
powder or powder blend without adding liquid to aid in the process. It serves as an established
manufacturing process in the chemical, life science, and pharmaceutical industries, playing a
key role in preparing powdered material for further processing.
Dry granulation equipment offers a wide range of pressure and roll types to attain proper
densification. However, the process may require repeated compaction steps to attain the proper
granule end point.
Flow Chart of Dry Granulation
Weighing and sieving of drugs and excipients
Dry mixing of API and diluents
Slugging or pre-compression
Milling and sieving
Lubrication
Discharge for compression

Direct compression
Direct compression is a standard and widespread approach of tableting in pharma industries as
it is rapid and proficient without having significant production expenses. Direct compression
is an efficient method of manufacturing tablets that requires fewest production steps. Apart
from process simplicity this method has reduced capital, energy cost and excellent for treating
water sensitive active ingredients. This method is used when a group of ingredients can be
blended and placed in a tablet press to make a tablet without any of the ingredients having to
be changed.
Weighing of drugs and excipients
↓
Mixing of all ingredients
↓
Sieving
Discharge for compression
29
Machineries Used During Granulation
New Machine
NO. NAME OF MACHINARY COMPANY NAME
1. RAPID MIXER GRANULATOR EAST, MUMBAI
3. FLUID BED DRIER SHIMADZU, JAPAN
4. WET GRANULATOR YENCHEN MACHINERY CO.LTD,TAIWAN
5. SIFTER YENCHEN MACHINERY CO.LTD,TAIWAN
6. V-CONE BLENDER YENCHEN MACHINERY CO.LTD,TAIWAN
Tablet Compression
Tablets are made by compressing a formulation containing a drug or drugs with excipients on
stamping machines called Tablet Presses or Tablet compression machine.
Tablet Compression is a manufacturing process used to convert powdered or granulated

pharmaceutical ingredients into tablets of a specific shape, size, and weight. This process
involves compressing the ingredients into a solid dose form using a Tablet Compression
machine.
It is a critical step in the production of solid oral dosage forms, as it ensures that the active
ingredients are uniformly distributed throughout the tablet and that the tablet has the required
physical characteristics, such as hardness, disintegration time, and dissolution rate.
The main aim of design and manufacture of compressed tablet is to deliver orally the correct
amount of drug in the proper form at or over the proper time and in desired location and to have
its chemical protected to that point.
30
Flow Chart of Tablet Compression
Granules (previously made)


Transfer of granules in the Hooper of tablet press machine
by hand or auto powder/granules loader

Rising of upper punch & dropping of lower punch

Filling of die cavity through feed frame

Removal of extra granules by scrape off plate

Coming down of upper punch for

Compression to produce tablet

Raising of both upper & lower punches to certain extent

Ejection of tablet with the help of take out plate

Conventional Uncoated Tablets
of desired shape and size
Common Problems that generally arise during compression are-

1. Capping
2. Chipping
3. Sticking
4. Weight variation
5. Mottling
6. Hardness problem
7. Lamination
Tablet Coating
Coated tablets are tablets that have one or more layers of a mixture of various substances, such
as natural or synthetic resins, gums, gelatin, inactive and insoluble fillers, sugars, plasticizers,
polyols, waxes, coloring matter approved by the competent authority, and, in some cases,
flavoring and active substances. Coating substances are typically applied as a solution or
31
suspension in conditions that allow the vehicle to evaporate. Film-coated tablets are those that
have a very thin polymeric coating applied.
Coated tablets have a smooth surface that is often colored and polished. A broken section, when
examined under a lens, reveals a core surrounded by one or more continuous layers of a
different texture.
Objectives of tablet coating-

1. To protect against deterioration by environmental factors like sunlight, temperature
variations, moisture, environmental gases etc
2. To facilitate swallowing.
3. To mask taste and odor
4. To increase shelf-life.
5. To enhance aesthetic appeal and brand image.
6. To facilitate product identification during manufacture and prevent wastage during packing
and handling
7. To provide immediate release, specific release, sustained release, controlled release and
targeted drug delivery properties.
8. To provide enteric release properties for release in the intestinal tract.
9. To facilitate identification of oncological drugs
Classification of Coating:
Mainly three types of coating are performed in the solid section. They are as follows:
1) Sugar coating
2) Enteric coating
3) Film coating
Film Coating:
A film coating is a thin polymer-based coat that is typically sprayed onto
solid pharmaceutical dosage forms, such as tablets, capsules, pellets or granules. Film coating
can impact both its appearance and its pharmacokinetics making it an essential process in
making the final drug product.
32
Film coatings are the most common form of drug coating and are generally applied in orally-
administered pharmaceuticals. The motivation for applying film coatings to dosage forms
range from cosmetic considerations (colour, gloss and branding), improving the shelf life by
providing a protective barrier between the drug and the surrounding environment, and making
the dosage form easier to swallow. These types of film coatings are known as non-functional
film coatings. They may also be used to delay or augment the delivery and uptake of
medications or delay release and uptake until the medication passes through the stomach. These
types of film coatings are known as functional film coatings.
Process Principles:
A very even application of the coating material is an important feature of the coating process.
Coatings must be dense and without mechanical damage and cracks. Film coating is an
effective process for the application of protective films for manipulating the product
characteristics. Glatt offers various technical solutions for coating different particles and
tablets:
1. Fluid Bed Coating (Top Spray Coating, Bottom Spray Coating, Rotor Coating)
2. Drum Coating
3. Spouted Bed Technology
4. In each case, the coating fluid is sprayed onto the solid material, which is presented to
it. The introduction of the process air evaporates the fluid and dries the film coating.
Small droplets and a low viscosity ensure a uniform distribution.
Enteric Coating:
An oral dosage form in which a tablet is coated with a material to prevent or minimize
dissolution in the stomach but allow dissolution in the small intestine. This type of formulation
either protects the stomach from a potentially irritating drug (e.g., aspirin) or protects the drug
(e.g., erythromycin) from partial degradation in the acidic environment of the stomach
erythromycin) from partial degradation in the acidic environment of the stomach.
33
Instruments / Apparatus Used in Tablet Coating
There are various types of sophisticated instruments are used for the purpose of tablet coating.
The instruments are:
➢ Coating Machine (FD&C Equipment Pvt.Ltd.), Karachi
Coating Procedure
1. Preparation of coating suspension:
Take purified water in a vessel.
↓
Add the ready coating materials carefully to the region of vortex
↓
Stir the dispersion for 45 minutes.
↓
Filter through 60 mesh size(if necessary)
↓
Add extra purified water for good dispersion (if necessary)
2. Coating process:
Coating suspension (Aqueous)
↓
Tablets into coating pan
↓
Warm up the core tablets for 10 minutes at 35-40°C
↓
Set the required inlet (60-70°C) and outlet(45-55°C) temperature.
↓
Start the coating pan
↓
Set the RPM of coating pan within 2-3
↓
Set the RPM of peristaltic pump within 8-12
↓
Set the atomizing air pressure within 3.5-4 kg/cm²

↓
Continue to spray by spray gun until all dispersion has been used
↓
Stop spraying after coating is completed
↓
Rotate the pan for 10 minutes to remove any solvent.
↓
Stop the blower, exhaust and heater and allow cooling.
Important critical parameters to check prior to spray coating solution
34
• Pump speed
• Pan Rotation
• Bed Distance
• Negative Pressure
• Inlet Air Temperature
• Outlet Air Temperature
• Atomizing Air Pressure
• Fluid Return Volume
• Nozzle Distance from the Tablet Bed.
COMMON PROBLEMS ASSOCIATED WITH TABLET COATING:
Logo Bridging
Cause:
1. Surface characteristics of the product being coated
2. Inadequate adhesion of film coating
3. Inadequate design of logo (e.g. too detail/fine logo)
Remedy:
1. Modify core formulation to include more hydrophilic ingredients
2. Increase core porosity
3. Using formulation with increased adhesion property.
4. Increase area within the debossing and modified angles.
Core Erosion
Cause:
1. Inherent softness or high friability of core.
2. Excessive pan speed in coating process.
3. Spray rate too low.
4. High sensitivity of core to moisture as coating is applied.
Remedy:
1. Increase mechanical strength of core.
2. Decrease pan speed.
3. Increase spray rate.
35
Edge chipping/erosion:
Cause:
1. Low mechanical strength of coating
2. Excessive pan speed
3. Low solid content in coating liquid
4. Low spray rate
5. Sharp edges on tablets
6. Worn tablet punches
Remedy:
1. Using formulation with increased mechanical strength
2. Decreased pan speed
3. Increase solid content in coating liquid
4. Decrease spray rate
5. Use modified punch design
Picking/sticking:
Cause:
1. Spray rate too high
2. Inadequate drying condition
3. Pan speed too low
4. Inadequate atomization of coating liquid
5. Poor distribution of coating liquid
Remedy:
2. Increase drying condition
3. Increase pan speed
4. Increase atomizing air pressure/volume
Cracking:
36
Cause:
1. Low mechanical strength of coating, exacerbated by inadequate plasticization,
excessive pigmentation.
2. Core has significantly different thermal expansion characteristics than coating.
3. Extended strain relaxation of core after compaction.
Remedy:
1. Selecting formulation with increased mechanical strength and elasticity properties.
2. Avoid use of mineral type fillers (e.g. CaCO3, CaSO4, MgCO3 etc.)
3. Extend holding period of tablets prior to submitting them to coating process.
Peeling:
Cause:
1. Low mechanical strength of coating
2. Poor adhesion of coating to tablet surface
Remedy:
1. Using ingredients of improved mechanical strength.
2. Using ingredients with improved adhesion properties.
Orange peel/roughness:
Cause:
1. Viscosity of coating liquid is too high
2. Poor atomization of coating liquid
3. Excessive drying condition
4. Over wetting (causing coating too rub)
Remedy:
1. Decrease solid content of coating liquid
2. Increase atomizing air pressure/volume
3. Decrease inlet air temperature/flow rate
Twinning:
37
Cause:
1. Spray rate too high
2. Pan speed too low
3. Inappropriate tablet shape
Remedy:
2. Increase atomizing efficiency
3. Increase pan speed
4. Select new tablet shape that decrease chances of flat surfaces coming into contact
during application of coating liquid. (e.g. avoid capsule shape tablet with thick side
wall)
Tablet-to-tablet color variation
Cause:
1. Too little coating applied
2. Inadequate mixing of tablet during coating
3. Poor opacity (or hiding power)
4. Solid content of coating liquid too high
5. Insufficient number of spray gun
Remedy:
1. Increase quantity of coating applied
2. Increase pan speed/increase improve baffle system
3. Reformulate coating with respect to colored ingredients or use an opacified white pre-
coat.
4. Decrease solid contents of coating liquid.
5. Increase number of spray gun.
Catering
It is defect of film coating whereby volcanic-like craters appears exposing the tablet surface.
Reason:
The coating solution penetrates the surface of the tablet, often at the crown where the surface
is more porous, causing localized disintegration of the core and disruption of the coating.
The Cause & Remedies of Cratering:
Sr. CAUSES REMEDIES

No.
1. Inefficient drying. Use efficient and optimum drying conditions.
2. Higher rate of application of Increase viscosity of coating solution to
coating solution. decrease spray application rate.
38
Pitting
It is defecting whereby pits occur in the surface of a tablet core without any visible disruption
of the film coating.
Reason
Temperature of the tablet core is greater than the melting point of the materials used in the
tablet formulation.
The Cause & Remedies of Pitting:

Sr. CAUSE REMEDY
No.
1. Inappropriate drying (inlet air ) Dispensing with preheating procedures at the
temperature initiation of coating and modifying the drying
(inlet air) temperature such that the temperature
of the tablet core is not greater than the melting
point of the batch of additives used.
Blooming
It is defect where coating becomes dull immediately or after prolonged storage at high
temperatures.
Reason:
It is due to collection on the surface of low molecular weight ingredients included in the
coating formulation. In most circumstances the ingredient will be plasticizer.
The Cause & Remedies of Blooming:
Sr.
CAUSE REMEDY
No.
High concentration and low
Decrease plasticizer concentration and increase
1. molecular weight of plasticizer.
molecular weight of plasticizer.
Blushing
It is defect best described as whitish specks or haziness in the film.
Reason:
It is thought to be due to precipitated polymer exacerbated by the use of high coating

temperature at or above the thermal gelation temperature of the polymers.
39
The Cause & Remedies of Blushing:
Sl. No. CAUSES REMEDIES
1. High coating temperature Decrease the drying air
temperature
2. Use of sorbitol in formulation which causes Avoid use of sorbitol with
largest fall in the thermal gelation Hydroxy Propyl Cellulose,
temperature of the Hydroxy Propyl Hydroxy Propyl Methyl Cellulose,
Cellulose, Hydroxy Propyl Methyl Methyl Cellulose and Cellulose
Cellulose, Methyl Cellulose and Cellulose ethers.
ethers.
Infilling
It is defect that renders the intagliations indistinctness.
Reason:
Inability of foam, formed by air spraying of a polymer solution, to break. The foam droplets
on the surface of the tablet breakdown readily due to attrition but the intagliations form a
protected area allowing the foam to accumulate and “set”. Once the foam has accumulated to
a level approaching the outer contour of the tablet surface, normal attrition can occur allowing
the structure to be covered with a continuous film.
The Cause & Remedies of Infilling:

Sl. CAUSE REMEDY
No.
1. Bubble or foam formation because of air Add alcohol or use spray nozzle
spraying of a polymer solution capable of finer atomization.
Orange peel/Roughness
It is surface defect resulting in the film being rough and nonglossy. Appearance is similar to
that of an orange.
Reason:
Inadequate spreading of the coating solution before drying.
The Causes & Remedies of Orange Peel/ Roughness:
Sl. No. CAUSES REMEDIES

1. Rapid Drying Use mild drying conditions
2. High solution Use additional solvents to decrease viscosity of
viscosity solution.
. The above problems can be overcome by following solutions:

• Select suitable coating material.
• Change spray rate.
• Change drying rate.
• Change distance between spray guns and surface of tablet bed.
40
• Change atomizing air pressure.
• Change inlet air temperature/air flow.
During our training we have observed the manufacturing of the following tablets:
• ESOCON MUPS
• R-Pil
In process quality control (IPC) of Tablet:
The in process control is made during the course of manufacture of tablet which aims to ensure
that products will comply with specification. Thus, quality is built into the product in
BIOPHARMA Limited; the following parameters are performed for in process checks:
Process In-process checks
Dispensing Weighing & recording
Mixing Time & Speed
Granulation Uniformity of content, time and speed
Drying Temperature (inlet & outlet) pressure, moisture content
Lubrication Uniformity of content
Compression Machine speed, Compression process, thickness, hardness,
friability, appearance, avg. and uniformity of weight, DT
of tablets
Coating Temperature, moisture, speed, time uniformity,
appearance, DT
Tablet Packaging
Tablet Packaging Section:

There are two different types of Packaging Configuration are used in Biopharma Ltd.
A. Blister Package
41
The blister package is formed by heat softening sheet of thermo plastic resin and vacuum
drawing the softened sheet of plastic into a contourd mold, Aluminum foil and PVC
blister are used in this packaging.
B. Strip Package
A strip package is formed by feeding two webs of a heat-sealable flexible film through
either a heated crimping roller or a reciprocating platen. Aluminum foils are used in this
packaging.
Following Packaging Machines are used in BPL
Blister machine-1
Company : Hoonga-A corporation
Source : Korea
Blister machine-2 (Automatic)
Company : Hoonga-A corporation
Source : Korea
We observed during Packaging:

• ACETA Tablet-500 mg.
• Cipcin 500mg
• Perilac 10mg
Liquid Processing Unit
Liquid:
The oral use of liquid pharmaceuticals has generally been justified by the ease of
administration to those who have difficulty swallowing solid dosage forms. A drug
administered in solution is immediately available for absorption and, in most cases, is
absorbed more quickly and efficiently than the same amount administered in tablet or capsule
form.
Advantages of Liquid Dosage Form
1. They are homogenous; there the medicament is uniformly distributed throughout the liquid.
42
2. The doses can be easily adjusted according to the need of the patient.
3. They can be easily measured with the household measured.
4. They are more quickly effective than tablets or capsule because they are already in the
solution form and absorption starts quickly.
5. They can be easily colored, flavored or sweetened.
6. Children or patient who cannot swallow tablets or capsule can easily ingest solutions.
Disadvantages of Liquid Dosage Form

1. They are difficult to carry and there are chances of breakage of container with the complete
loss of contents.
2. In some medicaments their unpleasant taste and flavor is difficult to mask.
3. They are less stable as compared to solid dosage form because deterioration is faster in
solutions.
Units of Liquid Section
1. Processing Unit
2. Filling & Packaging Unit.
Processing Unit:
In processing unit liquid dosage form of medicaments are prepared in appropriate vat.
Following steps are followed during manufacturing of liquid dosage form-
1. Requisition of raw materials.
2. Collection and rechecking of weighed raw materials.
3. Compounding.
4. Bottle washing and drying.
5. Sending the sample of prepared formulation to the QC department for further
working information about the prepared formulation. If QC passed the sample
as a quality product then the process of filling & Packaging is started.
In Liquid Processing Unit Two Types Of Liquid Dosage Form Are

Manufactured. These Are-
1.Syrup
2.Suspension
43
Production of Syrup:
Manufacturing Vessel
(Tanner stainless steel
Fabricating vessel)
Homogenizer
Filtration
Storage vessel
Bottle filling
Sealing
Labeling
Packaging
Production of Suspension:
Mixing active ingredient & excipients in manufacturingVessel
(Tanner stainless steel fabricating vessel)
Homogenizer
Particle size reduction by colloidal mill
Stirring
Storage vessel
Bottle filling
Sealing
Labeling
Packaging
44
During our training period, we have observed manufacturing of-
♦ LACTU syrup
Machineries Used in Processing Unit

2. Automatic filling Machine
3. Capacity :40 tubes/min.
4. Planetary Mixer.
5. Colloid Mill.
6. Steam jacket tank.
7. Laminar air flow unit.
8. Nitrogen gas line.
9. Compressed air line.
7. Holding tank.
8. Jabsco Pump.
9. UV Light.
In-process quality control of Oral Liquid Dosage form:
In BIOPHARMA Limited the following parameters are performed for in process checks-
Process In-process checks
Dispensing Weighing and recording
Mixing Time and speed, uniformity of mixing
Filling pH, Uniformity of content, Viscosity, appearance, self life etc.
Filling and Packaging Unit:
After getting the permission to fill the prepared liquid product filling process begin. For filling
liquid into bottle in BIOPHARMA Limited, Volumetric method of filling is used.
Process of Liquid Filling

Transfer of Prepared liquid preparation into the filling machine from the processing
vat by the use of transfer pump.
Set the machine according to filling volume
Filling of bottles
Sealing of bottle using sealing machine
Labeling & Packaging of bottles
In Process Check during Filling & Packaging

Process In-process check
Filling pH, Uniformity of content, Viscosity, appearance, self life, volume of
filling etc.
45
Packaging Sealing, Exp date, MRP, Batch no and other information on the packaging
material etc.
Machineries Used in Filling & Packaging Unit
♦ Liquid Filling Machine (Capacity: 30-40 Bottle/Minute).

♦ Liquid Sealing Machine
Cream & Ointment Unit
Cream & Ointment:
A cream is a topical preparation usually for application to the skin. Creams for application to
mucus membranes such as those of the rectum or vagina are also used. Creams may be
considered pharmaceutical products as even cosmetic creams are based on techniques
developed by pharmacy and unmedicated creams are highly used in a variety of skin conditions
(dermatoses).Creams are semi-solid emulsions, that is mixtures of oil and water. They are
divided into two types: oil-in-water (O/W) creams which are composed of small droplets of oil
dispersed in a continuous aqueous phase, and water-in-oil (W/O) creams which are composed
of small droplets of water dispersed in a continuous oily phase. Savlon A/C cream
manufacturing process are given below.
46
Materials Used:
1. Strong cetrimide BP
2. Chlorohexidine HCL BP
3. Cetostearyl alcohol BP
4. Liquid paraffin BP
5. Antiseptic perfume compossedPh.grade
6. Purified water
Machinaries Used in Cream Filling & Sealing:
Machine Name Specification and Origin

Automatic tube filling machine and sealing ZHE JIANG HUALIAN Pharma machinery
machine co.ltd, CHINA.
Automatic tube filling machine MAHARSHI Liquid filling machine, INDIA.
Positive liquid filling machine Bangladesh
Vacuum emulsification mixer TIANFU MACHINE,CHINA.
Automatic labeling machine HUNAN CHINASUN Pharmaceutical co.

ltd, CHINA.
Round over pilfer proof sealing machine Bangladesh

(R.O.P.P cap sealing machine)
Dry Syrup & Capsule Processing Unit
47
Dry syrup
Dry Syrup Section
Dry syrup is the preparation that is formulated as dry powder but administered orally as
liquid dosage form. They are prone to hydrolysis during extended exposure of moisture. They
are to be reformulated by mixing with certain amount of boiled water and should be use up
within certain periods (5 days at normal temperature).
Physical plant design:
It is divided into two areas-
1. Manufacturing area 2. Filling and sealing area.
Excipients used in dry syrup:

1. Sugar: Sweetening agent.
2. Colloidal silicon dioxide: Increase flow property.
3. Na-citrate/citric acid: Buffering agent.
4. Methyl paraben: preservative.
5. Color: FDC grade (Lemon, orange)
6. Flavor Raspberry, orange.
7. Na-CMC: Only for Cefidoxim as a suspending agent.
Precaution:
Temperature should be within 20-250C
Relative temperature should be within 30-35%
We observed the manufacturing of following Dry syrup

preparation:
• Biopen-VK DRY Syrup.
• Lactu syrup
48
Steps of Dry Syrup Preparation:
Weighing
Mixing
Sieving
Cone blending
Mixing
Q.C Analysis
Finished product
Machineries used for dry syrup preparation
Name of the machine: Riggs Autopade

Origin: England
Model: BB9OLD.
Other Machines are:
Mars Mechanicals Source: India
Mark Bottle Sealing Machine Source: Bangladesh
Kothari (Sugar Crushing Machine). Source: India.
Multimilling Machine Source: Bangladesh
Blender Machine (400 Kg).
Capsule
49
Capsule Section
Capsules are the solid unit dosage form of medicament in which the drug(s) is enclosed in a
practically tasteless, hard or soft soluble container or shell made up of a suitable form of gelatin.
Gelatin shells are supplied in a number of sizes. The number varies from 000 to 5, the former
being the largest and later the smallest. The exact amount of a medicament which can be filled
in a particular size of capsule shell depends upon density of the material to be filled in.
Generally the capacity varies from 600mg to 30mg.
Advantages
• Capsules are tasteless, odorless and can be easily administered.
• Attractive in appearance.
• The drugs having unpleasant odor and taste are enclosed in a tasteless shell.
• They can be filled quickly and conveniently therefore the physician can change the dose
and combination of drugs to suit the individual patient. This is an advantage over
tablets.
• Flexibility in onset and duration of action also contribute to the suitability of the capsule
as a pharmaceutical dosage form.
• Ease of formulation.
• Limited potential for incompatibilities.
• Good stability.
• Easy to swallow.
• They are economical.
• They are easy to handle and carry.
Disadvantages
• Capsules are not usually used for the administration of extremely soluble materials such as
potassium chloride or ammonium chloride.
• Capsules should not be used for highly effervescent or deliquescent materials. Effervescent
materials may cause the capsule to soften.
• Deliquescent powders may dry the capsule shell to excessive brittleness.
• The concentrated solutions which require previous dilution are unsuitable for capsules
because if administered as such lead to irritation in the stomach.
Process of capsule filling:
50
• Manual- This type of filling process is used to fill powder materials or the materials which
have poor flow property.
• Auto- Mainly pellets which have good flow property are used to fill by this process.
Procedure of Manual Capsule Filling:

Capsule shells are set into the plate through insetter
↓
Plate set into the hand filler
↓
Body and cap separated by scissor
↓
Fill the body with materials
↓
Attached body and cap
↓
Capsules
Machines Are Used:

• Auto-Capsule machine:
Name of company: Fuchang Machinery Company limited.
Model: NJP-800 series fully automatic hard capsule filling machine.
Origin: China.
Minimum output per minute: 600 pc’s capsule.
Maximum output per minute: 800 pc’s capsule.
• Semi Auto-Capsule machine:
In this machine the capsule pouring system is automatic, but the system of filling (powder,
pellets) or locking is manual.
Name of the company: Pharmaceutical and allied machinery company privet limited.
Model: SR NO: SA/25/21

Origin: India.
51
Fig. Hand Operated Capsule Filling Machine
Procedure of automatic Capsule Filling

Capsule shells into the hopper
↓
Meggine
↓
Cap boos and body boos
↓
Filling materials from chemical hopper
↓
Checking
↓
Close the body and cap by closing pin
↓
Capsule open from the boos by capsule open pin
↓
Capsules
52
Quality Control Department
Assigned person,
Farooque Ahmed Bhuiyan, Sr. Manager, QC
Aslam Ali, Asst.Manager, Microbiology
Ezazul Haque, Exe. Microbiology
53
Quality Control Unit
It is the part of good manufacturing practice, which is concerned with sampling, specification
and testing as well as the organization and documentation and released procedures. It ensures
the necessary and relevant tests that are necessary to determine whether the products will be
released or not for use, the raw materials can be used or not until their quality has been judged
to be satisfactory.
Biopharma Lab Ltd primary missions are to contribute to better health and quality of life for
people.
Quality control is responsible for the day-to-day control of quality in the company, who asses
and assure the testing of raw materials, in process testing and the finished product.
Diagrammatic representation of present QC activities.
Raw materials
analysis
Stability Finished
product
In process Microbiological
testing QC
testing
Analytic method Water and effluent

Validation
Packaging
materials analysis
Quality control department performs 3 types of assays for analysis.

1. Chemical Assay
2. Physical Assay
3. Bio-Assay
Quality control operations
The QC department assures manufacturing of quality product. It is related with production
operation, mainly done in the production to check.
• Dispensing of materials
• Checking in pharmacy weighing
• Compounding in ingredients
• Process validation
• Complains of GMP mainly storage of raw materials, finished products.
54
• Label control.
The objectives of quality assurance are achieved when processes have been defined which,
when followed, will yield a product that complies with its specification and when the finished
product.
• Contains the correct ingredients in the correct proportion.

• Has been correctly processed according to the defined procedures.
• Is of purity required.
• Is enclosed in its proper container, which bears the correct label or otherwise
suitably marked or identified.
• Is stored, distributed and subsequently handled in such a way that its quality is
maintained throughout its designated or expected life.
Quality Control = Testing + Assessment

This department consists of two sections :
1.Physical & chemical laboratory.
2.Microbiological laboratory.
Physical and Chemical Laboratory Test:
Test on raw materials.
Physical test:
➢ Identification.
➢ Solubility.
➢ Melting point check.
➢ LOD determination.
➢ Bulk density determination.
➢ Test of size, shape, color, and other speciations; of empty capsule shell.
➢ Particle size determination.
➢ PH determination for liquid.
➢ Optical activity determination.
➢ Weight, hardness, thickness and friability of tablet.
➢ Alkalinity test for ampoule.
➢
Chemical test:
➢ Potency determination test.
➢ Non aqueous titration.
➢ Iodomatric titration.
➢ Aqueous titration.
➢ HPLC method.
➢ UV method.
➢ Complexo-metric titration method.
➢ Potentiometer titration method.
2) Water content test:

➢ Karl-Fisher titration.
Test on in-process & finished products.
55
In-Process Control
Quality control section always performs in-process check. The In-process Control (IPC) is the
checks made during the course of manufacture which aims to ensure that product will comply
with specifications. This type of checks carried out during the manufacturing process.
In-process checks done by Biopharma Lab. Ltd. is given below
Tablet
Serial Process In-process checks
No.
01 Dispensing Weighing and Recording
Room condition (Temp. & RH).
02 Granulation Content Homogeneity of the granules
03 Drying Loss on Drying (LOD)
04 Compression Room condition (Temp. & RH)
Appearance of tablets (Sticking, Capping,
Lamination, chipping, )
Average weight of the tablet
Compression pressure
Hardness, Thickness & Diameter of tablets
Friability of tablets
Disintegration time
06 Coating Visual Inspection of appearance
07 Strip / Blister strip Leak Test
operation
Capsule

No.
01 Encapsulation Appearance of shell
Average Weight
Uniformity of weight & RSD
Disintegration time
Room condition (Temp. and RH)
02 Strip / Blister strip operation Leak Test
56
Liquid Processing, Filling & Packaging
Serial No. Process In-process checks
01 Bulk Appearance, Odor and color
PH
02 Filling line Fill volume / Fill weight
Cap Sealing
Appearance of filled liquid
Semisolid (Cream, Ointment, Gel)

No.
01 Dispensing Weighing and Recording,
02 Blending Proper mixing of raw material
03 Filling Fill volume / Fill weight
Sealing tube
Dry Syrup
Serial No. Process In-process checks
01 Dispensing Weighing and Recording,

02 Blending Proper mixing of raw material
03 Filling Fill weight
Sealing of cap
Packaging Materials
No.
01 Label Grain direction: the label is kept on water in a pot
and observed that it is properly rolled or not. After
awhile it will be opened to indicate that it is
passed.
Printing test (expires date, manufacturing date,
batch no)
The color & size are also checked against a
standard.
02 Cartoon The color & text are compared with an approved
standard.
Print over lapping check.
Proper locking check.
57
Finished Product Control
SL. Dosage Form Checks
No.
01 Leak test,
Tablet Packing Size,
Printing test (Expires Date, Manufacturing Date and
Batch Number.)
02 Leak test,
Capsule Packing Size,
Batch Number.)
03 Container test,
Vitamin Aluminum sealing test,
Cap sealing test,
Batch Number.)
03 Bottle test,
Liquid (Syrup, Microbial Contamination test.
Suspension) Cap sealing test,
Batch Number.)
04 Bottle test,
Dry Syrup Cap sealing test,
(Syrup, Printing test (Expires Date, Manufacturing Date and
Suspension) Batch Number.),
05 Cap sealing test,
Ointment, Printing test (Expires Date, Manufacturing Date and
Cream Batch Number.),
06 Sterile Impurities test under light.
Batch Number.),
Packaging Materials Analysis
Packaging materials analysis includes the inspection of all kinds of packaging materials such
as ampoule, bottle, rubber, seals etc.
Parameters that are checking for different packaging materials are given bellow.
Bottle:
➢ Appearance.
➢ Color.
➢ Ave. Weight.
➢ Neck screw cap.
➢ Mouth diameter.
➢ Body diameter.
➢ Height.
58
➢ External and internal diameter.
Rubber closure:
➢ Chemical test for acidity/alkalinity.
➢ Fragmentation test.
➢ Plug diameter.
➢ Flung diameter.
➢ Absorption test by UV-spectrometer.
➢ Total height.
Test for Foils:
➢ Appearance.
➢ Thickness.
➢ Ave. weight.
➢ Text.
➢ Lamination.
➢ Width.
Labels:
➢ Printing.
➢ Type of paper.
➢ Size.
➢ Breadth.
➢ Length.
➢ Thickness.
➢ Color.
➢ Appearance.
Inserts:
➢ Length.
➢ Text.
➢ Breadth.
➢ Types of paper.
Apparatus Used in Quality Control Unit:
High Performance Liquid Chromatography (HPLC):
Model: Knaucr, Germany.

Introduction:
High-performance liquid chromatography, HPLC is a popular method of analysis because it is
easy to learn and use and is not limited by the volatility or stability of the sample compound.
The information that can be obtained includes identification, quantification, and resolution of
a compound.
Principle
A liquid mobile phase is pumped under pressure through a stainless steel column containing
particles of stationary phase with a diameter of 3-10 m. The analyte is loaded onto the head
of the column via a loop valve and separation of a mixture occurs according to the relative
lengths of time spent by its components in the stationary phase. It should be noted that all
59
components in a mixture spend more or less the same time in the mobile phase in order to exit
the column. Monitoring of the column effluent can be carried out with a variety of detectors.
Applications:
➢ The combination of HPLC with monitoring by UV/visible detection provides an

accurate, precise and robust method for quantitative analysis of pharmaceutical
products and is the industry standard method for this purpose.
➢ Monitoring of the stability of pure drug substances and in drugs in formulations with
quantization of any degradation products.
➢ Measurement of drugs and their metabolites in biological fluids.
➢ Determination of partition coefficients a pKa values of drugs and of drug protein
binding.
Advantages:
➢ Easily controlled and precise sample introduction ensures quantitative precision.

➢ HPLC is the chromatographic technique, which has seen the most intensive development
in recent years leading to improve columns, detectors and software control.
➢ The variety of columns and detectors means that the selectivity of the method can be readily
adjusted.
Protocol for Quality Control Assignment

Sampling
(A quality assurance officer does it and

brings it to the QC Department)
60
Supervising
(A representative from the QC department receives
the sample & assign someone to analyze)
Analysis
(The analyst analyses the sample)
Checking
(After the tests, the results are checked)
Final approval
(The QC Manager verifies the result)
Collection
(QA officer collects the results of the sample That was assigned previously)
2. UV spectroscopy:
Mode: UV-1650PC
Source: Shimadzu, Japan
Mechanism of UV spectroscopy:
Prepared sample solution at very
Lower conc. usually several gm or mg level
Poured into UV cell which is cleaned

With alcohol and the sample solution,
which is to be detected
At first blank (only solvent) and standard are

placed into UV spectrophotometer
and absorbance is taken in specific wavelength
Standards are replaced with sample
Absorbance was taken and determined the amount by using equation.
61
3.FTIR (Fourier Transform Infrared Spectroscopy):
Model: FTIR-8300
Source: Shimadzu, Japan
Mechanism of FTIR:
Produce KBr disc of sample (raw materials)
here very minor amount of sample is used
and it must be free from moisture
Placed within IR spectroscopy
Allowed to pass IR through sample disc
Show absorbance
Compare with standard
4.Atomic absorption Spectrophotometer

Mode: Shimadzu, Japan
Quantity: 01
5.Analytical Balance
Model: B 204S, Switzerland
Quantity: 01
6.Microscope
Origin: Germany
7.Flask Shaker
Origin: India
8.pH meter
It is used to determine the pH value.
Origin: United Kingdom
9.Hot Air Oven

Origin: Germany
10.Melting Point Apparatus

Model: A63004, Origin: U.K
11.Colony counter
Mode: 8301, Origin: Germany
62
12.I.R Humidity Control Chamber
Model: MPRT-U 160/100, Origin: Germany.
13.Refractometer
Origin: Japan
14.Tablet Testing Apparatus

Model: E-70, Origin: India
15.Water-bath, boiling
Model: Type-3030, Origin: Germany
16.Autoclave
Origin: China
17.Micrometer
Origin: Japan
18. Tablet Hardness Tester

Origin: India
19. Refrigerator
Origin: Mitsubishi, Japan
20. Dissolution Test Apparatus

Model: DA -6D, Origin: Veggo, India
Microbiology Unit
63
Microbiology Unit
Microbiology department is the department where various microbiological tests are performed
to kill, free, count or suppress the micro-organism. The tests which can not be performed
chemically go through microbiological test.
Activities
➢ Microbiological analysis of raw materials and finished products.
➢ Bioassay of antibiotics using different methods such as Diffusion method, Turbidity
method.
➢ Regular test of non ionized water, tap water and bulk water.
Various types of tests performed in the Microbiological department of Bio-Pharma Lab. Ltd.
are shown as below:
➢ Test for sterility.

➢ To cheek pathogenic microorganism.
➢ Limit Test.
➢ Pyrogen test/Lal test (for sterile product).
➢ Water Quality test (for WFI)
➢ Microbiological assay.
Test for sterility:

Sterility is the defined as full free from living microorganism but the dead body of
microorganisms may be present. The test for sterility is done for the Sterile raw materials.
BIOPHARMA Ltd. Sterilized all of those products by using the following methods.
FILTRATION METHOD
Test for sterility of microorganism by using cellulose membrane filter in the filtration method.
The pore size is 0.22 micron & diameter is 47 mm.
Procedure of sterility test by filtration method:

The procedure of filtration method by using test for microorganism is follows.
(Filter paper and filtration apparatus to be sterile for filtration method)

Cellulose filter membrane + Apparatus is sterilized
To set a filter paper in the filtration apparatus
The liquid to be tested is added in the filter funnel
64
The liquid is passed trough the filter paper
Filter paper is removed from the filtration apparatus by forceps
Filter paper is cute by scissor
Added to the media
Filter papers with media keep the incubator (7 to 14 days)
Observation of microorganism growth
No turbidity
Sterility passed
2. To cheek pathogenic microorganism:
To cheek pathogenic microorganism on the basis of various food the following media
are used:
Ordinary media:
e.g.
✓ N B – Nutrient broth.
Indicated media:
e.g. Blood agar
➢ Spatially following organism are tested in the microbiology section:

➢ Escherichia Coli.
➢ Salmonella Sp.
➢ Staphylococcus aureus.
➢ Pseudomonas aeruginosa.
3. Limit test: This test is performed for the following materials:
➢ Raw material.
➢ Oral liquid.
➢ Semisolid e.g. cream, ointment etc.
65
Method of Limit Test:
10 gm of raw material or semisolid is mixed up uniformly with 100 ml of water. From
this solution 1 ml of the solution is transferred to a petridish, and then a suitable media
is added for particular organism.
4. Chemical test for WFI:

This test is performed for detection of the presence of different chemicals such as Ca,
Cl, Fe, Mg etc by using different chemicals wich readily react with these chemicals.
Instruments used in microbiology department:

➢ Autoclave.
➢ Laminar air flow.
➢ Biosafety cabinet.
➢ Hot air oven.
➢ PH meter.
➢ Vacuum filter.
➢ Vibrator.
➢ Incubator.
➢ Refrigerator.
➢ Microscope with camera.
➢ Auto/computerized zone of inhibition counter.
➢ Air supplier for air sampling.
Comments:
We expect that the
1. Microbiology department of Bio Pharma Lab. Ltd. will be extended in future.
2. The space is very small for conducting experiments.
3. The washing room should be separated from the microbiology laboratory.
66
Warehouse & Inventory Control Department
Md. Mobarek Hossain

Manager, PPIC
67
Introduction:
The warehouse is an essential part of the pharmaceutical industry. Here the raw materials are
stored in specified condition.
The Warehouse of BIOPHARMA Ltd. is properly organized. Different Tags with different
colors are used to identify the materials easily in the storage area in specific space.
Raw Materials Storage Area:

The raw materials are store in divided into three parts, these ares-
1. Quarantine Area
2. Rejected Materials area
3. Main storage area
1. Quarantine Area:
After receiving of raw materials they are stored first in the quarantine area. After Q.C.
sampling and checking, the approved materials are shifted to the main storage area
and the rejected materials are transferred to the rejected materials area.
2. Rejected Materials Area:

Here, the rejected materials are stored either for destroy or return to the supplier.
3. Main Storage Area:

Here raw materials are stored. There is another isolated storage area for sophisticated
materials maintaining temperature and humidity in side the main storage area named
cooling room.
Important Functions:
➢ According to monthly program, this department has the responsibility to get
final Q.C. approval for raw materials.
➢ According to plan and recovery maintenance, the raw materials are supplied
to the production area for required batch size.
➢ Specific raw materials are stored in specific mentioned area with proper
documentation. Capsule shells are kept in 150c & aluminum foil in 00c to
250 c.
➢ There is another room in second floor of Orion where various stationary &
gift items are stored.
Packaging Materials:
Packaging materials, e.g. master pack, carton, foil, inner pack, catch covers etc are stored here
with controlling humidity and temperature.
68
Working Procedure of Warehouse:
The raw materials and packaging materials are dispensed according to the requisition sheet of
the production. The total procedure given below-
FIG:
Flow of raw materials from the ware house
Total Procedure of Warehouse:
Marketing department submit fore cost form in ware house
Raw material name written in requisition book
Checking the material in the ware house, if the material is not

present ware house inform the marketing department.
Then the commercial department calls for a tender.
Price caudation by supplier
Tender box is open in presence of all departmental managers.
High quality &law price holder are selected by the committee.
69
Vander evaluation by quality assurance.
Supplier supplies his raw material quality assurance.
Raw material transfer into the quarantine area (uncheck

material are present there).
Quality control tests the material. Then the QA pass materials

are store in the cooling area (temperature 15-25 oC and relative
humidity maximum 50%)
If the materials are not approving by QA then commercial

department called the supplier to return or change the material.
Retest & reassessment the material by QA.
70
Engineering Department
Assigned person,
Md. Mostafizur Rahman
Sr. Asst. Manager, Engineering
71
Introduction:
Biopharma Lab. Ltd has an independent maintenance department for looking after production
and utility machineries. The responsibilities of maintenance department are to install, maintain,
handle and solve all types of problems such as electrical and mechanical problems. Utility
support is very important for smooth operation of all production machineries.
Concerned area of Engineering Department
• Engineering department is concerned for operation and maintenance of utility machines

and provide,
1. Power supply
2. Water system
3. Steam supply
4. Gas supply
5. Compressed air supply
6. Central Air conditioning System
• Engineering Department is also concerned for maintenance of all production machineries.

Maintenance can be classified into two categories-
a) Schedule/ Preventive maintenance

All production machineries are checked routinely for ensuring efficient operation and
minimum breakdown.
b) Breakdown maintenance
It is done when any machine is out of control due to mechanical or electrical problem.
Working Procedure of Maintenance Department:
Maintenance department classified their work into 3 classes. These are as follows-
➢ Preventive maintenance
➢ Breakdown maintenance
➢ Daily checking
Flow Chart of Working Procedure:
72
Water Treatment & Distribution System:
Water is essential for pharmaceutical manufacturing & cleaning purposes.
Water used in pharmaceutical plant is of following kinds
 Potable water
 De-mineralize (DM) Water.
 Water for Injection (WFI)
Potable water:
Water is pulled below ground by a submersible pump. This water is then use as drinking,
washing floor and room and further it is used to produce DM water as well as water for injection
(WFI).
De-mineralize (DM) Water:

Potable water is filtration through cation exchanger and anion exchanger, where present
charcoal. The filtrate water is further filtrate by mixed bed exchanger, the cation exchanger
system is wash by HCL and anion is wash by costic soda.
73
Finished Product of Biopharma Ltd.
Introduction:
Every production biased company has a ware house. There are three types of ware house.
Finished product store exist of them. It plays vital role to support SCM (Supply Chain
Management) as well as keeping stock management. F.P store has loyal obligation. So it should
not exist in out side of the plant. It must have been in the plant. But other two stores should be
out side if production has sound logistic support to convey product resources. Through F.P
store SCM is starting to transmit product to end user.
Major duties & Responsibilities:

➢ Receiving product from production through a transfer slip.
➢ Sending it CDC (Central Distribution Centre) over demand of distribution
department.
➢ Prepare VAT challan (mushak-11)
➢ Maintain purchase book (mushak-16)
➢ Maintain sales book (mushak-17)
➢ Maintain current book (mushak-18)
➢ Prepare vat statement(mushak-19)
➢ Prepare export application form(mushak-20)
➢ Submit VAT challan to customs office
➢ Perform VAT related other activities
➢ Receiving bill of entry and local challan from commercial dept., RM and PM dept.
Room arrangement:
1) U-Shape
2) I-Shape
Connection to other department:
-Communicate with-
-Production,
-Commercial Dept.,
-PMD.
74
-VAT Section
-Finance & Accounting Dept.
-Costing Dept.
-Externally related with customs excise and VAT Department of
- Bangladesh Revenue Board.
75
Product of Biopharma
76
SUPRALEX
Cefuroxime BP 250mg capsule
Cefuroxime BP 500mg capsule
Cefuroxime BP powder for suspension 100ml
(125mg /5ml)
BESTCEF
Cefixime USP 200mg capsule
Cefixime USP dry powder for suspension 37.5ml
(100mg /5ml)
Cefixime USP dry powder for suspension 50ml
(100mg /5ml)
MEXTIL
Cefuroxime BP 125 mg tablet
Cefuroxime BP 250 mg tablet
Cefuroxime BP powder for suspension
70ml (125mg /5ml )
77
BIOTRIM
Cotrimoxazole (Sulphamethoxazole BP 400mg &
Trimethoprim BP 80 mg ) tablet
Cotrimoxazole BP dry powder for suspension 60ml
(SMZ 200 mg/ 5ml & TMP 40 mg /5ml)
BIOTRIM DS
Cotrimoxazole double strength
(Sulphamethoxazole BP 800mg & Trimethoprim BP
160 mg ) tablet
EROSA
Erythromycin USP 250 mg film coated tablet
Erythromycin USP 500 mg film coated tablet
Erythromycin USP powder for suspension 100ml
(125mg /5ml)
Erythromycin USP paediatric drops 15ml (100mg /ml
)
Erythromycin USP paediatric drops 30ml (100mg /ml
)
MACZITH
Azithromycin USP 250 mg capsule
Azithromycin USP 500mg film coated tablet
Azithromycin USP dry powder for suspension 15ml
(200mg /5ml)
ANTI-FUNGAL DRUGS
FUNGATA
Fluconazole BP 50 mg capsule
Fluconazole BP 150mg capsule
Fluconazole BP dry powder for suspension 35ml
(50mg /5ml)
Fluconazole BP dry powder for suspension 60 ml
( 50mg /5ml)
ANTI - PROTOZOAL DRUGS

BIOZYL
Metronidazole BP 400mg film coated teblet
Metronidazole BP suspension 60ml (200mg/5ml)
ANTI - HISTAMINES
78
BIOCIN
Chlorpheniramine maleate BP 4mg tablet
Chlorpheniramine maleate BP syrup 100ml(5mg/5ml)
LORFAST
Loratadine INN 10mg tablet
Loratadine INN suspension 60ml (5mg/5ml)
ANTI - EMETIC
ESOGUT
Domperidone BP 10 mg film coated tablat
Domperidone BP suspension 30 ml ( 5mg /5ml)
Domperidone BP suspension 60 ml ( 5mg /5ml)
Domperidone BP paediatric drops 15ml (5mg /ml )
Domperidone BP paediatric drops 30ml (5mg /ml )
AVERT
Meclizine HCI USP 50mg tablet
ANTHELMINTICS
AZOLE
Albendazole USP 400mg chewable tablet
Albendazole USP suspension 10ml (200mg/5ml)
BIOTREX
levamisole BP syrup 30ml (40mg/5ml)
ANTACID & ANTI-ULCERANTS

BIOCID
Antacid (Aluminum Hydroxide BP250mg +
Magnesium Hydroxide BP 500mg chewable tablet)
BIOCID MH
(Aluminum Hydroxide BP +Magnesium Hydroxide
BP ) suspension 200 ml
79
Suggestion
Within Bangladesh, BIOPHARMA is a prominent pharmaceutical company. With ISO

9001 certification obtained in 1995, it is the first ISO certified company in
Bangladesh.Thus, identifying any irregularities in their operations is quite challenging.
Despite the fact that this is a world-class factory, we may offer some recommendations to
address some of its noticeable issues in order to guarantee both the plant's workers' and the
products' safety.
We believe that the following recommendations should be made:
Quality Control Department:
✓ For improved analysis, a number of malfunctioning equipment needed to be fixed.
✓ Maintaining its environment more strictly may be more particular.
✓ It is desired to expand the space.
✓ Avoid using unhygienic sinks.
Production Department:
1. Solid Unit:
• The solid and LCO Departments may be divided from the dispensing area.
• One may be able to move more deliberately.
• This is where antibiotic production can be avoided.
• It might be more preferable for personnel to wear long aprons throughout the
granulation phase.
• In this case, compliance activities could be enhanced.
2. SVP and Cephalosporin unit:

• It is desired to separate the Cephalosporin unit as soon as possible.
3. WareHouse:
• It is possible to manage raw material and finished product storage
separately from warehouse 2.
• Space may be enlarged
• Self-life storage room may be separated from warehouse.
• The warehouse may be kept in a more hygienic and salubrious state.
• Products that were damaged were kept in ware house-2 for an extended
period of time. To free up some space, these products might be
eliminated.
• One region's products were found in another.Therefore, this needs to
be considered.
• It is recommended that human and animal health products be stored in
completely distinct locations.
4. Other:
• Each trainer or guest should have an adequate supply of clean
aprons, shoe covers, masks, and hair covers.
80
Conclusion
With the cooperation of the authorities and all the staff, our eight days of training at
BIOPHARMA Ltd. went by extremely quickly, but we still learned a lot and gained a lot of
experience that will be useful for our future practical needs. We were warmly welcomed by the
appropriate authority in each section. They piqued our interest in the pertinent topics and
sparked our curiosity. We are happy with how each and every employee in the factory has
behaved. We therefore feel that we have finished our training with great satisfaction, and we
hope that you feel the same.
We thought the following technical features of BIOPHARMA Ltd. were particularly
commendable:
The BIOPHARMA Ltd. plant in Tongi has an outstanding plant layout. It was undoubtedly a
really well thought out arrangement that maximises space utilisation, is simple to use, and
greatly aids in achieving maximum productivity. Moreover, there is plenty of room to grow
when the time comes. Additionally lovely is the plant section, which has a prayer space of its
own
A pleasant and sympathetic culture boosts a company's production, therefore it's great if the
factory is well-organized and the internal environment is supportive of the employees. There's
always space for improvement, but the meal menu was thought to be excellent and the canteen
is also really attractive.
Biopharma Ltd. is impressive for the variety and high calibre of its products. Additionally, we
were quite pleased with the company's adherence to ISO 9001 standards in terms of GMP
maintenance and thorough documentation of all work performed.
One of Biopharma Limited's most noteworthy accomplishments is their efforts to launch
valuable products at a reduced pricing point.
Finally, we would like to express our gratitude to Almighty Allah, all of the participants, and
ourselves for the successful completion of this training. We also hope that Biopharma Ltd. will
continue to cooperate in order to permit In-plant Training in the future.
The Ends
81

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REPORT ON

IN-PLANT TRAINING PROGRAMME IN

Since Biopharma Limited is one of the fast-growing pharmaceutical companies in Bangladesh

BIOPHARMA is the largest exporter of pharmaceuticals from Bangladesh in developing

Specially we express our appreciation to -

Md. Abul Bashar (General Manager, Plant)

Nesar Ahmmed (Deputy Manager, HR and Admin)

Abu Saleh Akram (Asst. Manager HR and Admin )

Sheikh Arif Hasan (Assistant Manager, QA)

Md. Hafizur Rahman (Senior Deputy Manager, Production)

Md. Zahidul Islam Khan (Senior Assistant Manager, Production)

Md. Jobaer Alam (Assistant Manager, Production)

Farooque Ahmed Bhuiyan (Sr. Manager, QC)

Md. Masudur Rahman (Assistant Manager, PD)

Md. Mostafizur Rahman (Senior Assistant Manager, Engineering)

Md. Mobarak Hossain (Manager, PPIC & IC)

practical knowledge that will help us for future improvement.

for the compassionate behavior of all executives and workers.

pharmaceutical industries. So, our objectives are-

➢ To see and understand how a pharmaceutical company runs, how to differentiate

➢ To know how GMP or cGMP is applied in the plant.

➢ To know about SOP.

➢ To know how pharmacists solve manufacturing problems.

➢ To know how quality is assured as well as controlled.

Biopharma Limited is always committed to assure the best quality pharmaceutical

Head Office Plant

No. Area of observation Page No.

BMR Batch Manufacturing Record

BPR Batch Packing Record

SOP Standard Operating Procedure

IHS In House Specification

QSP Quality System Procedure

WIP Software Based Work In Procedure

MRN Material Receiving Note

BOM Bill Of Materials

GMP Good Manufacturing practice

cGMP Current Good Manufacturing practice

LOD Loss On Drying

ETP Effluent Treatment Plant

RMG Rapid Mixing Granulator

FBD Fluidized Bed Dryer.

COA Certification Of Analysis

PPIC Production Planning and Inventory Control

Quality Assurance Department:

QA is the heart and soul of quality control

The In-process duty of QA department is

3. POWDER FOR SUSPENSSION-

A. Granulation and blinding:

4. SEMISOLID AND SUPPOSITORY-

Flow Chart of Sampling of Incoming Materials:

Check visually each container/box/packet

Make a sampling plan

Clean the selected container/box/packets

Collected sample from each selected containers/boxes/packets

Affin “Sampled Tag” & “Under Test Tag” on those

1. Prospective process validation: Validation conducted prior to the distribution of a new

• Pre qualification (under specification, design & operation check out)

Items of Self Inspection:

➢ Physical and chemical analysis of the newly developed products.

➢ Accelerated Stability Study of the new products.

➢ Process Validation of 3 consecutive batches.

Reformulation of Existing Product:

Step-3: Collection of raw materials of active drug and excipients.