INTERNSHIP REPORT

INTERNSHIP AT:
ERVA HELTHCARE PVT. LTD.

INTERNSHIP BY:
Ms. HITESH DHOLARIYA
 ACKNOWLEDGEMENT :

The internship opportunity I had with ERVA HELTHCARE PVT. LTD. was a great
chance for learning and professional development. Therefore, I consider myself as a
very lucky individual as I was provided with an opportunity to be a part of it. I am
also grateful for having a chance to meet so many wonderful people and
professionals who led me though this internship period.

Bearing in mind previous I am using this opportunity to express my deepest gratitude

and special thanks to the my guide Ms.kajal A. pradhan ,assistant professor, Smt.
R.D. Gardi B. Pharmacy college (Nyara)Rajkot who in spite of being extraordinarily
busy with his duties, took time out to hear, guide and keep me on the correct path
and allowing me to carry out my project at their esteemed organization and
extending during the training.

I express my deepest thanks to Mr. HITESHBHAI DHOLRIYA , QC manager and Mr.

CHETANBHAI GOHIL , PRODUCTION Manager for taking part in useful decision &
giving necessary advices and guidance and arranged all facilities to make life easier.
I choose this moment to acknowledge his contribution gratefully.  
 TEBLE OF CONTENT:

Sr no: Particular Page

no:
(1) Introduction

(2) Overview of industry

Abstarct

(3) Aims & objective

(4) Department of Industry

(5) Observation

(6) Discussion

(7) Conclusion recommendations

(8) Reference
 INTRODUCTION
 Vision

To enroll into a crusade of creating better life for the society & providing the
best therapeutic measures for the human healthcare.

 Mission

To achieve a marked entity in pharma world with the innovative approach &
develop into one of the finest manufacturing facility which can endorse larges
product Portfolio

 Erva Healthcare Pvt.Ltd. is Located in Rajkot City in Gujarat and its

 Manufacturing Facility is Spread Over 25000 Square Feet Area.

 Erva Healthcare Pvt.Ltd Produces Only Non-Betalactum Drugs.

 They Produces Tablets, Capsules and External Preparations.

 They Produces 100% Pure Quality Products.

 They Follow All the GMP Guidelines.

 They have More Than 40 People’s Well-Trained Staff.

 They Have a Great Hygienic Condition of Industry.

 The Production Capacity of Tablets is 4 Crore Tablets Per Month.

 The Production Capacity of Capsules is 1 Crore Capsules Per Month.

 The Production Capacity of Ointments is 4000 Kg Per Month.

 They Have All Newly Bought Instruments So Chances of Instrumentation

Errors are Rare.
PHARMACEUTICAL INDUSTRY: INDUSTRY OVERVIEW
Established in the year 2016, we “Erva Healthcare Private Limited. It is
situated at plot no. 11 RK Industrial hub, kuvadava wankaner Highway
At, Ranpur, Gujrat.
Because of their strong dedication to high quality products and services
they have developed a great portfolio of International Clients, Toll
Partners, Institutional Buyers and Marketing.
Erva Pharmaceuticals is an ISO 9001:2008 certified company and
therefore assures that cGMP (current good manufacturing practice)
strictly followed at all levels of manufacturing process. The
manufacturing facility has been planned keeping in view the up-to-date
cGMP rules.
This industry has all the essential sections of Medicine. They have a
layout according to the international standard. It is centrally air
conditioned and have latest machinery.
Erva is armed with the modern equipment for production, quality
control and quality assurance. Erva manufacture all form of drug
delivery systems like, solid orals (tablets, capsules), and ointment.
 ABSTRACT

I Pursued My Industrial Training at Erva Healthcare Pvt.Ltd.

It Offers Training to the students in almost all the departments of Industry to become
familiar with instruments and industrial environment.
Training is an opportunity to relate what has been covered in class and what is
applicable in the field in an operational environment.
During my Training period, a number of approaches and exposure methods were used
which included: hands on, through reading relevant material, and also questions and
answer approaches.
I was assigned to different departments which include the RM (Raw Material), QC
(Quality Control), QA (Quality Assurance), Production and this helped me interact
with different people and this helped me acquire information.
In conclusion, this was an opportunity to develop and enhance skills and
competencies in my career field which I actually achieved.
 AIMS AND OBJECTIVES

• Following are the aims & objectives of ERVA pharmaceutical:

• To establish the marketing relationships with the leading international

pharmaceuticals companies in future by launching their innovative and
research product.

• To promote the growth and success of its associates and international

competitiveness and export performance of industry.

• To discover new ways, technologies and products to manage health.

• Devoted to inventing medicines that allow patients to liver longer healthier

and more productive lives.

• The main of object is to do fundamental analysis of a pharmaceutical of

companies.

• To develop and promote Gujrat image as an attractive manufacturing giant in

innovative healthcare products.

OBJECTIVE

 Main objective of training is to be familiar with the equipment’s used in the

industry and to learn how the Machineries and management of industry is
done.
 Also, to learn how to maintain the proper hygienic condition of industry to
give the Best Quality of product.
 To Know how the Different departments of industry works.
 To learn how the Records of manufacturing batches are recorded and to
maintain it regularly.
 To understand the Different roles of Pharmacist in Different departments of
industry.
 To get experience of industrial field while studying.

 To know how actual guidelines like GMP, cGMP, GLP etc are being
maintained as we already studied from the books.
 DEPARTMENT OF INDURSTRY

Company is involved in the manufacturing of almost all segments of products having

its independent manufacturing sections which are controlled with centrally air
handling system. There are following main departments of ERVA Pharmaceutical.

• Ware house
• Row material store
• Quarantine area
• Quality control department
• Quality assurance department
• Production department
1. Teblet section
2. Capsule section
3. Ointment section

WARE HOUSE:

It receives raw material. Unit this material is cleared it is remain there.

Temperature and humidity are kept under control.

• Raw material operator

• System operator
• Manager store & distribution
• Distribution in charge
• Finish good operator

PREMISES:

• It is was well situated, well laid out, tidy, clean and well secured enabling
• good preservation of raw material, packaging material and finished
products. • Temperature was maintained between 15-30 c
• Job description of the ware house included:
Responsibility to control inventory of stocks (finished, packaging and
Raw material stores).
• Checking physical stocks regularly.
• Preparing Daily & Weekly stocks Reports.
• Raw material store.
• Packing material store.
 • Finish good store.

RAW MATERIAL STORE:

Raw material store was further divided into following:

1. Quarantine area
 Packing material quarantine
 Raw material quarantine

2. Excipient area
3. Active pharmaceutical ingredients

 Toll
 Envoy

4. Dispensing area
 For antibiotics
 For cephalosporin
 For general materials

5. Chiller area
 QUARANTINE:
All raw materials, components, packaging, and labeling materials are
held in our "quarantine" area until they are sampled, tested and/or examined, and
released for use by our "quality control laboratory". The sampling is performed
according to specific procedures by trained personnel.
This area is divided into two sections

 Packing material quarantine

In this section packing material for different dosage forms is kept under

recommended and controlled atmosphere

 Raw material quarantine

In this section raw material is kept under normal conditions active

pharmaceutical ingredients is kept in 15-25 C®, excipients are kept at 25 C® in

subsection of this area
  Chiller area
In this area normally temperature sensitive products are kept in separate area to
prevent them from damage or detoriation.

 Dispensing area
Dispensing area is also present in raw material section where dispensing is
performed under manufacturing order of a product at time of dispensing 4

personnel’s should be present there to check the process of dispensing according to

SOP.

 Production pharmacist
 Q.A pharmacist
 Raw material store pharmacist
 Raw material dispense

DOCUMENTATION:
Following documentations were done in ware house at different stages:
• Temperature/humidity chart.
• Dispensing log book.
• Raw material requisition.
• Raw material analysis report.
• Request for retest.
• Certificate of analysis.
• Issuance of slips (Pink slip: material identification, Yellow slip: sampled at
QC, Green slip: passed from QC).
 QA (QUALITY ASSURANCE) DEPARTMENT

Quality Assurance (Q.A) is the sum total of organized arrangements made with the
object of ensuring that product will be of the quality required by their intended use.
Quality assurance is the systematic monitoring and evaluation of the various
aspects of a project, service or facility to maximize the probability that minimum
standards of quality are being attained by the production process.QA cannot
absolutely guarantee the production of quality products.
In ERVA, there was a pharmacist to maintain the reliability at every stage of
manufacturing process starting from Research, Clinical studies, Quality Control,
Production, Distribution and provides information on appropriate use, and analyzes
safety and information of the products. This department assists in the strategic
direction and development of Quality Systems, standard operating procedures and
document control programs, to ensure with the company policies and regulatory
requirement.

Role of Quality Assurance in industry

 Temperature check
 Humidity checking
 Line clearance (at different stages, in line clearance our focus is on cleanliness
proper identification of product batch No. packing procedure, product
labeling)
 Stability testing
 Maintain record
 Dispatch testing
 Handling of market complains
 Dispensing checking
 In-process testing
 SOP designing
 Workers training
 Validation
 Self inspection / internal audit
In-process test for Tablets
Q.C perform following test for in-process testing of tablets

 Appearance (color, size, shape)

 Wt. variation
80 mg o <± 10 %
80 – 250 mg ±7.5%
> 250mg ± 5%

 Average wt.
 Disintegration
 Hardness
 Thickness
 Diameter
 Dissolution time
 Friability test
Wt. before =A
Wt. after= B
𝑥=
A−B
𝐴
X 100

In-process test for Capsule

 Physical appearance
 Disintegration test
Average wt.

 Wt. variation
350 mg or <± 10 %
350 mg or <± 7.5 %

In-process test for Liquid Preparation

 pH
 Viscosity
 Weight per ml
Wt. of empty pychno-meter = A
Wt. of pychno-meter + liquid/ suspension = B
Wt of liquid/ suspension = B – A =C
Wt./ml =C/25

 Deliverable volume
QC (QUALITY CONTROL) DEPARTMENT
“Quality is our priority.”
“Quality is never an accident, always the result of intelligent effort.”
The quality control department is responsible to ensure that all materials meet the
established criteria throughout all phases of the process. Raw materials,components,
and packaging and labeling are examined and tested according to a rigorous written
program designed to assure uniformity from batch to batch. Every raw material
received is tested for identity and conformance to specifications. Every bottle, cap,
and label is examined to assure that they match the written specifications. During
the manufacture of all batches of all products, in-process samples are tested and the
results documented. If any results fall outside of the written specifications, the
product is rejected and the information is submitted to the research and
development group for evaluation and further disposition. Samples of finished,
packaged product are tested for stability to allow for determination of expiration
dating. Accelerated stability testing as well as real time stability testing is done
concurrently to validate the results of the tests.

Activities of Quality control department in ERVA were:

• Testing and release or rejection of all incoming raw materials, packing materials,
in-process / intermediates and finished products as per specified specifications.
• Maintaining testing records as per standard procedures for raw materials, packing
materials, in-process / intermediates and finished products.
• Calibration of laboratory instrument / equipment.
• Performing stability study.
• Analytical method validation.
• Preparation of standard volumetric solutions and maintain standardization record.
• Maintain Labeling procedure at all the stages and records.
• Maintain working / reference standard record of products.
• Analysis of complaint samples as and when required.
• Follow safety norms at all the stage during handling of chemicals and using
instruments.
• Follow good laboratory practices.
Raw Material Inspection

Raw Material

Receipt

Verification

Sampling

Under Test

Q.C Testing

Approved Rejected

For manufacturing Return to supplier/Destruction

PRODUCTION AREA
Production team is committed to produce highest quality products, which can satisfy
the needs of both doctors and patients. The production team endeavors to
manufacture products that are cost-effective through best utilization of their
resources. This department is well equipped with latest equipment.
Warning in industry:
You are entering to Production Area please wear,
• Cap.
• Overall.
• Shoes cover or change your shoes.
In ERVA pharmaceutical Production Area is divided into following section:

 General Tablet Section

  General Capsule Section
 Ointment section

TEBLET SECTION
Tablet
A tablet is a mixture of active substances and excipients, usually in powder form,
pressed OR compacted into a solid. The excipients include binders, Glidants (flow
aids) and lubricants to ensure efficient tabletting, disintegrates to ensure that the
tablet breaks up in the digestive tract; sweeteners or flavors to mask the taste of
bad-tasting active ingredients; and pigments to make uncoated tablets visually
attractive. A coating may be applied to hide the taste of the tablet's components, to
make the tablet smoother and easier to swallow, and to make it more resistant to
the environment, extending its shelf life.

Advantage
 Production aspect
 Large scale production at lowest cost
 Easiest and cheapest to package and ship
 High stability
 User aspect (doctor, pharmacist, patient)
 Easy to handling.
 Lightest and most compact.
 Greatest dose precision & least content variability.
 Coating can mark unpleasant tastes & improve pt. acceptability.

Disadvantages
 Some drugs resist compression into dense compacts.
 Drugs with poor wetting, slow dissolution, intermediate to large dosages
may be difficult or impossible to formulate and manufacture as a tablet that
provide adequate or full drug bioavailability.
 Bitter taste drugs, drugs with an objectionable odor, or sensitive to oxygen
or moisture may require encapsulation or entrapment prior to compression
or the tablets may require coating

Tabletting methods( Granulation )

 Dry methods
a) Direct compression
b) Dry granulation
Wet methods
  Wet granulation
 STEPS INVOLVED IN TABLET MANUFACTURING:

• DISPENSING OF RAW MATERIAL:

Tabletting process starts with dispensing of active ingredients. Weigh and
dispense system begins with a pharmacist getting a bill of materials for
ingredients that make up a recipe for a batch to be manufactured. Each
material must be gathered from a warehouse. Then it is verified as the
proper material, carefully weighed, checked again, and finally readed for
mixing in the recipe.

• DRY MIXING:

Ribbon mixer is used for mixing.

RIBBON MIXER
 WET MIXING:
After dry mixing, wet mixing is done in the ribbon mixer.

 WET GRANULATION:
Wet granulation is used for wet granulation and mesh size 4 & 6 are
used.

 DRYING:

• FBD (Fluidized Bed Dryer).

Or
• Tray dryer is used for the purpose of drying.
FLUIDIZED BED DRYER TRAY DRYER

DRY GRANULATION:
Oscillating granulator is used for dry granulation & mesh size used is 16.

OSCILLATING GRANULATOR
• LUBRICATION & FINAL MIXING:
Final mixing is done in DC (Double Cone) mixer.
 DOUBLE CONE MIXER
• COMPRESSION:

Rotary tablet machine is used for compression. Zp-

17and ZP-33 are being used.

• COATING:

Spray Gun (High Efficiency Coating Machine)

&Thiocota is used for coating of tablets.

SPRAY GUN MACHINE

• LABELING & PACKING:
Two types of packing is done:

 Alu-PVC.
 Alu-Alu.
Tablets are packaged into strip and blister packaging and then finally in shippers
  Alu-PVC Packing:
For Alu-PVC packing Alu-PVC blistering
machine is used.

Specification:
• Having heater in start.

• Batch no. & Expiry date.

ALU-PVC PACKING MACHINE

 Alu-AluPacking:
For Alu-Alu packing Alu-Alu blistering machine is used.

Specification:
• 3 pinch.
• Temperature 140-150°C.
• Batch no. & Expiry date is printed.
• Sealing foil.
 ALU-ALU PACKING MACHINE;
CAPSULE SECTION:

“Capsules are solid unit dosage form of medicament.”

Followings are some examples of capsules manufactured by ERVA;
 Ometor (Omeprazole)
 Emage (Esomeprazole)
 Mylid (Azithromycin)
 Akurate (Cefixime)
STEPS INVOLVED IN CAPSULE MANUFACTURING:
• DISPENSING OF RAW MATERIAL:
Capsulation process starts with dispensing of active ingredients. Weigh
and dispense system begins with a pharmacist getting a bill of materials
for ingredients that make up a recipe for a batch to be manufactured.
Each material must be gathered from a warehouse. Then it is verified as
the proper material, carefully weighed, checked again, and finally readed
for mixing in the recipe.
• FILLING OF CAPSULE:
The mixture is1 filled in empty capsule. ENVOY pharmaceutical, presents
an exclusive array of capsule filling machinery. This capsule section
machinery is semi automatic. Capsule section machinery is simple to
operate.

1
 CAPSULE FILLING MACHINE

• CAPSULE POLISHING:
After capsule filling capsules were polishes in full automatic capsule
polishing machine.

CAPSULE POLISHING MACHINE

• LABELING & PACKING:

Two types of packing is done:
• Alu-PVC.
• Alu-Alu.
Capsules are packaged into strip and blister
packaging and then finally in shippers