INDUSTRIAL TRAINING REPORT

DONE BY

AMIT SHARMA

BU2016UGPHM052

AT

ACCENT PHARMACEUTICALS AND DIAGNOSTICS

For Duration Of Month

From 6th July To 5 thAugust 2018

Submittd to

School of Pharmaceutical Sciences

Bahra University Waknghat

Solan 173234 (H.P)

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Company Profile
Scott-Edil Advance Research Laboratories & Education Ltd. is a Pharmaceutical manufacturing
unit , located at Hill Top Industrial Area, Bhatoli kalan Baddi, Distt : Solan (H.P.) India, which is
approx. 45 kms. away from Chandigarh. It is located on an open plot area appox. 68000 square
meter, & built up area is approx. 12000 square meter. The factory under establishment in year
2010 & is situated in a serene atmosphere free from vehicular and any adverse environmental
pollution. 

Scott-Edil Advance Research Laboratories & Education Ltd has separate production Block
which is categorically utilised for production of Following Dry Powder Injectable,
Tablet,Capsule and Dry syrup Formulations:
1. Block DPI (Dry Powder Injection)
2. Block OSD (Tablet, Capsule & Dry syrup).

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 MISSION OF THE COMPANY

Consistent with the vision and values of the founder strives to strengthen India’s
industrial base through the effective utilization of staff and materials. The means
envisaged to achieve this are high technology and productivity, consistent with
modern management practices.

OBJECTIVES OF THE COMPANY

The corporate plans are to ensure growth through organic means, and by adopting
strategic methodologies. The objective is to maximize the revenues and reduce
risks. Resolve complex chemical challenges and offer advanced drugs to the global
markets. Emerge as a leading player in global high quality innovative specialty
generic formulations and domestic brand segments.

STRATEGY OF THE COMPANY

Scott-Edil is focused on increasing the momentum in its key markets through

organic and inorganic growth routes. It continues to evaluate acquisition
opportunities in India, emerging and developed markets to strengthen its business
and competitiveness.

VISION OF THE COMPANY

The future as we see has the unlimited avenues in store for us. Spreading the
message of medicine, we sincerely look forward to venture into high profile
therapeutic segments expanding beyond the known frontier, the market we have
well planned courses to combat the challenges.

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 QUALITY CONTROL(QC)

Quality control is an essential operation of the pharmaceutical industry. Drugs

must be marketed as safe and therapeutically active formulations whose
performance is consistent and predictable. New and better medicinal agents are
being produced at an accelerated rate.

The term quality control refers to the sum of all procedures undertaken to ensure
the identity and purity of a particular pharmaceutical. Such procedures may range
from the performance of simple chemical experiments which determine the
identity and screening for the presence of particular pharmaceutical substance (thin
layer chromatography, infrared spectroscopy, etc.), to more complicated
requirements of pharmacopoeial monographs. Activities extend to the area of
quality control laboratories (good laboratory management practices, models, e.g.
for certificate of analysis and lists of laboratory equipment, and an external
assessment scheme.

All personal involved in the Quality system have the mission to assure the quality
of the medicines manufactured and packed in the pharmaceutical industry.

The quality control (QC) in a big industry usually is divided on:

 Release :- Responsible to verify if the sample of the batch still with the
same atributes (content, dissolution, etc.) as the product tested on clinical
trials. obs: Is important to mention here, that is a batch sample, no, is not
possible to test all the units that a industry manufacture, so, that's why the
QC does only one part of the quality system.

 Development/ Validation : - The QC should develop the tests that are

done in the release, when not described in any pharmacopea. And these
methods should be validated, in other words, the method should be
capable, reproducible, specific, exact, sensible, etc.

 Stability :- QC has to perform studies that atests the expire date of a

product. These studies are based on the region that the product is sold

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 (here in Brazil the conditions to tests are 30°C / 75 % relative humidy, in
US is 25°C / 65% RU).

 Raw Material :- The QC also, is responsible to sample and analyse the

raw material batches used  to produce a batch of a finish
product, including packaging materials.

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 QUALITY ASSURANCE(QA)

Quality assurance is a wide concept that covers all aspects that collectively or
individually impact the quality of the product. That is, the sum of organized
arrangements that are made with the aim of ensuring pharmaceutical products are
of the required quality as per the intended use.

Quality assurance is a good practice in the manufacture of pharmaceutical

products, as it is the process of vouching for integrity of products to meet the
standard for the proposed use. It is an obligation that ensures manufacturers meet
the needs of end-user needs in terms of safety, quality, efficacy, strength, reliability
and durability. Quality is a benchmark of perfection for the end-user.

Although it is almost obvious that the formation of a pharmaceutical quality

system is the sole responsibility of the quality assurance unit or department, a
majority of the required elements that are seen to be duties of quality assurance
may be implemented through a networked organization that incorporated suitable
specialized departments. As such, they may be handled under the umbrella of other
functions.

Thus, the best way of dealing with it is through a quality assurance department or
unit as a global function that has a direct line or reporting to senior management or
executive level. Quality assurance would therefore focus on provision of suitable
systems as well as defining them in SOPs and higher level instructions on
provision of appropriate information.

Quality assurance exists to serve a number of objectives that include the

following:

 To offer a guarantee that the person who is administering medicine is

confident that every unit will achieve the desired effect.
 To protect users for products from possible accidental defect in the
manufacture, design, storage as well as usage instructions.
 To ensure the law is complied with to the latter.
 To offer protection of the manufacturing organization.

Breaking down the central function of a quality assurance unit and delegating to

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employees in the other operation departments especially in production, makes
sense particularly in larger and highly specialized organizations that have long
connecting pathways.

This means they would be available as contact persons around to ensure quality on
the floor. Consequently, it is mandatory for quality employees to be provided with
the right decision making authority giving a guarantee for short decision routes.

For operational unit managers and quality managers to be equal partners,

employees must have well founded special knowledge of workflows within the
operational unit.

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INTRODUCTION

Scott-Edil group is a professionally managed pharmaceutical business for the manufacturing and
marketing of quality pharmaceuticals. Today, we have four regulatory approved world-class
manufacturing facilities with presence across India and over 15 countries. We cater to generics
and branded generics in India and overseas in a variety of dosage forms including syrups,
capsules, ointments, oral liquids, tablets, external preparations, dry powder injections and liquid
injections. Our range includes more than 700 products across several therapeutic segments
including antibiotics, analgesics, anti-ulcerative, vitamins and supplements, anti-hypertension
and anti-diabetes.

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Manufacturing Facilities
Scott-Edil Pharmacia Ltd. is a Pharmaceutical manufacturing unit, located at Baddi, Distt : Solan
(H.P.) India, which is approx. 45 kms. away from Chandigarh, in pollution free milieu of
shivaliks. Easily accessible and well connected. It has plot area appox. 1 Lac 70,000 sq. feet &
built up area is in access of 1 Lac square feet.

Building is constructed with good quality construction material . The flooring for the
manufacturing, filling, dispening and packing area of all the sections are smooth & epoxy filled.
Underground drainage system is provided with drain points having specially designed water
locking system.

Effluent treatment plant is installed to take care of effluents generated from various sections. A
total number of 40 independent air handling units (HVAC systems) have been provided in the
facility. Each process operation has separate air handling system and has temperature and
humidity control. The environmental control is maintained to avoid any cross contamination. A
central water chilling plant is maintained for provision of chilled water which is circulated to all
the air handling units. Dust extraction systems with hoods have been provided for all dust
generation areas/ equipment.

Separate warehouse for flammable solvents and corrosive reagents

Proper conditions like humidity & temperature are maintained to store Raw material,Packaging
material and finished Goods.
APPROVALS
Toxicity and Bioequivalence studies for new drugs are carried out at Jadhavpur University,
Kolkata. We have got DCGI permission for manufacturing and marketing of following new
drugs:

Parenterals:

Ceftriaxone + Sulbactam

Ceftriaxone + Tazobactam

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Cefepime + Tazobactam

Ceftazidime + Tazobactam

Capsules:

Rabeprazole + Domperidone

Pantoprazole + Domperidone

Amoxycillin + Dicloxacillin

Tablets:

Aceclofenac + Paracetamol

Ofloxacin + Ornidazole

Cefexime + Clavulanic Acid

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 STORAGE AREAS :

MATERIAL STORAGE TEMPERATURE

Active pharmaceutical ings Storage in A.C.room (below 25°c tem)

Excipient Stored at room temperature

Empty capsule shells Stored in an A.C. room (below 25°c tem)

Packaging material Stored at room temperature

Active ingredients and capsule shell are very sensitive hence stored at lower temperature.

The stored materials are labeled with different color of labels as per testing done in O.C
department.

COLOUR OF LABEL POSITION OF TESTING

Yellow under test

Green approved

Red rejected

All are approved samples are sent to respective department as per requirement.

Material Receipt Note are prepared for packaging Material.

3 copies of material receipt note are required.

1st is for finance it is required for payment.

2nd is for Q.C it is required for sampling.

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3rd is for store It is required for record.

For the under test area weight is according to sq route + 1.

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 Q.C. For Packaging Material :

Annealing test is performed for glass ampoules Polaris cope. polarscope consists of a
lens and sodium lamp. An ampoule is placed between lens and sodium lamp. Ampoule is
rejected if any ring or ring like structure is observed in the lens.

Hydraulic pellet press is used to test the plastic containers. Hydraulic pellet press
forms the file of plastic container whose IR spectra is taken to identify the type of plastic.

Bursting strength tester (burst o matic) is used to determine the strength of corrugated
box. The pressure required to break corrugated box is measured in PSI unit.

Pinhole detector is used to check the integrity of aluminium foil. This pinhole in the
foil is detected manually by keeping on light.

For Raw Material :

In warehouse, we can also store raw material.

For it we must have a daily check of its weight on weighing balance.

The main difference between raw material storage and packaging material storage is :-

Temprature

Packaging material is stored only at 25. c, where as raw material is stored according to.

1. Ambient (room temp)

Not exceed 39.c

2. below 25.c
3. 2 to 8.c (cooling temp)

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In U.S. Two brands are available.

1. Tyco
2. Zygneries

In raw material. First Expiry First Out System is must.

Product name for the approved department in packaging area are :

 Losartan ,Riboflavin,Simvastatin.

If material are stored for more than one year,it must be rechecked before using.

It is also know as Black Area. Because we can not open any Material in

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CENTRAL PHARMACY
Objective :- The role of central pharmacy department in any pharmaceutical industry is to
dispense required ingredients in required quantity.

The department has various sections as follows :-

1. Raw material staging room

2. Liquid dispensing booth
3. Sifting rooms
4. Sifting material staging room
5. Dispensing booth (total 5)
A. 2 booths for dispensing API
B. 3 booths for dispensing excipients.
1. Raw material staging room :-
According to the B.M.R raw material is issued from warehouse which is then transferred
to central pharmacy and is stored in this room.

2. Liquid dispensing booth :-

This room is meant for dispensing of liquid Materials.The liquid material is dispensed
through a Pump which is air operated pump. The top of the drum of the liquid to be dispensed is
attached to one of the pipe of the pump which withdraws the liquid from the drum due to
pressure and the required quantity of liquid coming out is transferred to the respective drums.
The pump has two separate divisions for dispensing.

a) For propylene glycol.

b) For liquid other than glycol

Special care is taken for propylene glycol because it is used in manufacturing of

parenteral solutions. so the sole aim here to avoid contamination of Propylene Glycol with other
liquids.

3 Sifting rooms :-

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Equipments : Vibro sifter.

Communicating mill.

The solid materials to be dispensed needs to be sifted according to the B.M.R before
dispensing. The material is sifted in a sifter. Sifting is done in order to make all the particle of
uniform size. For some product even Air Jet Mill is also use to ensure uniformity in particles
of given powder. In vibro sifter different type of mesh size is used. For sifting and milling 4
rooms are available.

4 Sifted material staging room :-

Material after sifting are transferred in this room and stored before dispensing. This room
serves as store room of sifted materials.

5 Dispensing booths :-

Dispensing booth is a place where actual dispensing takes place. The booths are air
locked to prevent the interference of outside air currents. It has reverse laminar air flow so no
unwanted air currents are formed inside the rooms. Each booth has 2 weighing machine. one
for big quantity dispense and other for small quantity dispense. which are used according to
quantities of the materials to be dispensed. The weighing machines are connected to the
computer so the quantity of the material dispensed is noted down followed by generation of
slip by computer which has all the details of the dispensed drug like. Name of material
dispensed.

Temperature of this area NMT 30 ‘C’

Humidity of this area is NMT 60%

The material which is not used must be returned to the warehouse.

Central pharmacy is also known as Grey area because here the material can be Opened.

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 TABLET MANUFACTURING

Tablet manufacturing is one of the important area as tablets form the major bulk of solid
dosage form. The various areas are :-

1 Granulation area
2 Granule quarantine area
3 Approved granule store
4 Tablet compression area
5 Tablet quarantine area
6 IPQC
7 Tablet inspection area
8 Coating area
9 Approved tablet area

Various methods of tablet manufacturing are :-

1 Wet granulation
2 Dry granulation (using roller compactor e.g. chilsonator)
3 Direct compression.
General scheme of manufacturing includes :-

1 Milling
2 Sieving
3 Mixing
4 Granulation
5 Granule drying
6 Sieving
7 Lubrication
8 Compression

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The various equipments used are :-

1 Rapid mixer granulator

2. High speed mixer granulator

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 3. Oscillating granulator

4. Turbo sifter

5. Multimill

6. Fluidised Bed Drier

1. Egg shell blender

1. Rotary press

2. Gans coater 1500 (Gasons)

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The various Tablet Ingredient are :-

1 Active ingredient (drug)

2 Diluents-lactose. spray dried lactose. mannitol. Avicel PII 101/102/112 dextrose,
Emulex. Celutab etc.
3 Binders-maize starch. PVP, IIPMC, MCCssss
4 Disintegrents-Primogel. Explotab. Ac-Di-Sol-MCC
5 Lubricants-magnesium stearate
6 Chiants –Aerosol Cab-O-Sil talc
7 Sweeters-aspartame, eyelamate
8 Colors & Flavors.

The various Tablet Defects are :-

1 Capping
2 Lamination
3 Picking
4 Sticking
5 Chipping
6 Mottling
7 Black spots
8 Weight variation

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 Granulation:

For granulation, total 5 areas are available.

It is grouped based on the capacity difference.

Area Capacity

Gra-1 60 kg 150 liter

Gra-2 100 kg 400 liter

Gra-3 300 kg 650 liter

Gra-4 400 kg 750 liter

Gra-5 500 kg 12000 liter

In the process of granulation, ingredients are loaded with The help of vacuum then binder
solutions are added in the Rapid mixture granulator.

So wet mass will form. In it impeller is used for good Mixings &

cheaper is used for avoid lump formation.

Then drying of the wet mass will done in fluid bed dryer In it with the help of hot air.
material get fluidized.

Then material are transferred from different sieves to get In powder form of mixture.

Area 5 is the one of the most biggest area in the granulation process & area 1 is smallest
area in this process.
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Compression:

In the compression different station machine are available in tablet manufacturing.

Total 12 compression machine are in the compression.

Some machine are as follows :

32 station cad mach machine.

12 station cad mach machine.

55 station cad mach machine.

75 station cad mach machine.

Here cavin & cadmach machine are available in the compression machine.

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Generally, in this process first material is passed from the hopper after in the fidder powder
filled in die then going in roller and compress the material.

Now tooling is decided according to the product.

Tooling is divide in the 3 ports like.

 Upper Punch
 Dye
 Lower Punch

Function of dye cavity :-

In the dye cavity the material is fill and compressed the both punch & ejected in out side and
according to shape product is out side and according to shape product is out side the dye
cavity.

75 & 55 station cadmach machine are more high speed in the compressed machine.

55 & 75 station machine are doubled rotary machine in the compression.

Product name : Atenolal

I.P.Q.C. of the compression :-

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1. Balance

2. Friabilator

To check the friability and tablet strength.

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 3. Disintegration tester (USP)

4. Weight variation.

Product name : loridine

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Coating :-

In the coating process ganscoater machine is used.

The capacity of ganscoater machine is 1200 mm.

In this process first the material is sprayed through the spray gun and a film of coat is
developed which is then left for 10 min for its drying.

Product name : Simvastatin

I.P.Q.C of the coating :

1 to check the roughness of the tablet

2 orange peel

3 Sticking & picking

In the tablet manufacturing total bunker area is 12

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 Tablet packaging

In the pharmaceutical industry. it is vital step that the package selected adequately preserve the
integrity of the product. The selection of a package therefore begins with a determination of the
products physical and chemical characteristics. The materials selected must have the following :

1 They must protected the preparation from the Environment Condition.

2 They must not reactive with product.
3 They must not impart to product tastes or odors.
4 They must be nontoxic.
5 They must be a FDA approved.
6 High speed packaging material.

The whole packing department is divided into main four areas.

1 Primary packaging storage

2 Approved tablet store
3 (3) Tablet quarantine store
4 Tablet inspection store

There are mainly three type of tablet packaging :

1 Packaging of tablet into strips

2 Packaging of tablet into blister
3 Packaging of tablet into plastic bottle (bulk packaging)

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 Blister Packaging :-
It is the type of packing in which the tablet is filled into plastic pockets covered with aluminum
foil.

The step of packaging are :

1 Formation of cavity into PVC foil temp = 100-180c

2 Filling of tablet into cavity

3 Coding of aluminum foil

4 Sealing of two film temp = 120-230c

5 Cooling

6 Cutting of blister

7 Packing into final paper box.

The rejected blister are separated from tablet by de-blister machine.

Strip packaging :-
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Strip packing is same as blister packing but instead of the plastic foil both the film are of
aluminum.

The equipment working on this principle is ROTOVAC 210+.

This equipment is also known as ALU-ALU packaging machine.

The step of packaging are :-

1 Filling of tablet between to foil

2 Coding of aluminum foil
3 Sealing of two film temp=125-200c
4 Cooling
5 Cutting of strip
6 Packing into final paper box
7 Printing on paper box (mfg & exp date)

Packaging area are of two type :-

1 primary packaging area

2 secondary packaging area

Packaging :-

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The containers used are mainly made up from glass and plastic

 Plastic containers :-

The principal ingredient if the various materials used for container is the thermoplastic
polymer : Although most of the plastic materials used in the medical field have a relatively
low amount of added ingredients, some contain a substantial amount of plasticizers, fillers,
antistatic agents, antioxidants and other ingredients added for special purposes

The ingredients are not usually chemically bound in the formulation and, therefore. may
migrate out of the plastic and into the product under the conditions of production and storage.

Considerable variability also has been encountered in the purity of the commercially

available polymers.

problem of leaching, absorption and permeation

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  Glass containers :-

The glass that is most resistant chemically is composed almost entirely of silicon dioxide,
but it is relatively brittle and can only be melted and molded at high temperatures.

Boric oxide somewhat modifies the above characteristics as it enters the structural
configuration, but most of the other oxides apparently enter the spaces within the structure
and reduce the strength of the interatomic forces between the silicon and oxygen.

Therefore, the latter oxides lower the melting point of the glass and are comparatively
free to migrate.

Consequently they also lower the chemical resistance of the glass that is, they may
migrate into a product over a prolonged period of contact, particularly with aqueous
solutions.

Advantages are visibility and cheap and easily made by tubing and molding. The
disadvantages are that they are easily breakable.

 Blister packaging :-

The vials are packed in the blister and for that the machine is automatic in which one side
the PVC roll came and then by means of vacuum the sufficient size of pocket is made and

31
then from the other side the aluminum roll came and then by means of heat the sealing is
done and finally at downwards the cutting of the strip occur.

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EVALUTION PARAMETERS FOR THE PRODUCTS :-

1 Leak test by means of vacuum is done. if any crack or not properly

2 sealed ampoules easily breaks and removed.

3 For checking the alkalinity of the glass the test is performed.
4 The BREWITY INSPECTION MACHINE was there for checking the glass particles,
fibers, black particle and white particle in the vials. There are 3 cameras, two of them
used for same purpose for glass and fiber particle checking while another with red LED
used to check black particle and volume determination.
5 Black particles and white particles is checked against the white and black
background respectively manually for ampoules.

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 Q.C. DEPARTMENT

Quality Assurance systems and test regimens must be in place to ensure that medicines are made
reliably and reproducibly, i.e the contents of the container match the label claim.

Quality Control evaluation is performed on materials prior to blending to confirm identification,

purity and impurities for medicine ingredients and packaging components are as per
specifications.

The level of active ingredients and other physical and chemical parameters are tested at the
completion of the dose form manufacture. As appropriate, microbiological testing is also
performed.

For all dose forms, tests include appearance, identification/content/concentration of the active
ingredient

Other tests may include:

Liquids

Colour/flavour

pH

Tablets

Rate of disintegration/dissolution in water

Hardness

Friability (toughness)

Suppositories

Melting point

Smoothness

Hardness

Creams and Lotions

pH

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Consistency

Liquid Injections

Formation of particulates

pH change

35
 PARENTRAL DEPARTMENT

Parentral [par- beyond, enteral- git] are injectables containing one or more medicament dissolved or suspended
in a suitable vehicle and are introduced into body from any route other than oral. It is administered by means of an
injection.

PARENTERAL SECTION -

 Gray zone of parentrals.

 Storage room
 Wasting
 Decartoning area
 Washing and sterilization area
 Quarantine
 I.P.Q.C
 Janitor room
 Inspection area

White zone of Parentral.

 Filling and sealing area -Sterilization area.

PROCEDURE-

 Raw material from ware house -Raw material is supplied by the ware house as per BMR
and is stored in storage room at suitable temperature and humidity.

 Decartoning of ampoules and vials.

 Washing and sterilization –

Equipments-

 Ampoule washing machine

 Ampoule sterilizing tunnel
 Depyrogenating tunnel

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 Washing-
It is carried out by-
* Highly purified water (60c) passed through 1 Om filter.
* Air jet (0.2 m filter) of compressed air. Two jets
of air
* Water for Injection (WFI)
* Air jet.

Sterlization-
Ampoules are then passed to Ampoule sterilizing tunnel to dry heat sterilizer
(Pejroklenz co.) where they are dry heat sterilized at a temperature of 330-370ºc.
 Cooling- They are then cooled by air and HEPA filters.
 Ampoule filling and sealing -This is carried out in class 100 aseptic area with:
Vertical laminar air flow system.

Equipments -

 Ampoule filling machine

 ampoules are filling at one time.

Filling-

Ampoules are first exposed to nitrogen gas to remove 02 present in it. Then they are filled
with accurate close of medicament are re-exposed to nitrogen.

Sealing-

Ampoule sealing is done by pull-sealing method using a flame of Oxygen and LPG. The
ampoules are allowed to rotate and the flame is concentrated on sealing point. As the glass is
sealed, remaining part pulled off.

Moist heat sterlization-

 Sterilization is done in order to remove and kill all micro organisms and bacteria from
preparations.
 Equipment- Double door autoclave.
 Temperature- 121 -124ºc.
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  Time- 20 minutes.

o One door of autoclave opens to filling and sealing area while other opens to unit operation
area. There are certain loading patterns which are strictly to be followed.
o PLC (Programmable Logical Curve) display reveals - temperature relationship used during
sterilization process. The room also consists of an LAF of efficiency 100/f per min. + 10.
o Leak test of ampoules- Ampoules are kept in inverted position in autoclave (0.15 vacuums) for
5 minutes. Then they are weight to analyze lose of fluid.

 Inspection-

The stored finished product is transferred to inspection room from quarantine. There are
three methods of inspection-

 Visual inspection- This is done manually by checking in front of black and white
backgrounds respectively.

 Semi- automatic inspection-Equinity- checking machine. It is used only for fibers and
particles. Four ampoules are checked at one time. Inspection is manual.

 Automatic Inspection-Equipment-Automatic inspection machine.

Optical rejection can be done due to presence of fibre, black particle, glass particle,
improper sealing and less volume.

 Packaging and Labeling-

Ampoules are blister packed with one foil of PVDC and another printed aluminum foil
which consist of following information-

 Name of medicament
 Quantity
 Composition
 Dosage

38
 Name of manufacture
 Marketed by
 Batch no.
 Expiry date
 Equipment -HSP ampoule sticker labeling machine.

39
CONCLUSION.

It was a great experience for me to take training in such a renowned & well established
pharmaceutical company.

This training period. during my educational period was very important for me to improve
myself as a pharmacist. It helped me a lot in gaining practical knowledge & what are the
latest invention & research going on. Also this training was beneficial for me because it was
a chance where I was able to imply my theoretical knowledge & for this.

I am thankful to SCOTT EDILLA Pharmaceutical & my college Institute of Pharmacy.

I am sure this training will help me a lot in future as a Professional pharmacist.

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