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INDEX

SR.NO. CONTENT PAGE NO.

1. Industrial profile 2

2. Capsule 3-8

3. Liquid 9-11

4. Packaging 12-18

5. Quality control & Quality Assurance 19-21

6. Raw and packaging material storage 22-23

7. Conclusion 24

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INDUSTRIAL PROFILE
Talking about the Organization Vibgyor Laboratories (INDIA) would really be a story of an
enterprise, which from just a very small beginning could attain the forefront position in its place
only through firmness of purpose, honesty of effort and sincerity of labor.

The organization Vibgyor Laboratories (India), is today a well-reputed industry in Allahabad

with their manufacturing unit as well as marketing unit with 11 to 25 numbers of employees

The company is established in1970 by H.S. Prasad of the company, located in No. 27, Daud
Nagar Industrial Colony, Naini Allahabad-211008

This is the manufacturer of multivitamin & antioxidant Syrup, multivitamin & antioxidant
capsules, protein powders.

The key product is KOFGON SYRUP being manufactured by the laboratory on large scale.

 PROPRIETOR- Mr. Harish Prasad Rana

 CEO- Mr. Vibhor Rana

 CHIEF MFG CHEMIST- Mr Sanjay Chaturvedi

 PRODUCTION CHEMIST- Mrs. Preeti Sharma

 QA AND BUSINESS HEAD- Mr Anuraag Jaiswal

 PACKING AND DISPATCH MANAGER- Mr Balraj Bajaj

 QC CHEMIST- Mr Surendra Kushwaha

VISION STATEMENT

To provide best quality product in minimal cost having experienced knowledge of the market,
manufacturing. We have been able to attain huge client base. Factor responsible for our
enormous success are as follow: In depth industry knowledge Timely completion of orders

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transparent business dealing qualified and trained team of professionals for manufacturing and
marketing.

Figure 1 Marketed preparation of Capsule

INTRODUCTION
Capsules are a solid dosage form in which the drug substance is enclosed in a water soluble shell
or an envelope. A capsule shell is made from gelatin. The capsules are available both as hard
capsule and soft capsule.

Advantages of capsules:
1. The drugs having unpleasant odour and taste can be administered by enclosing them
in a tasteless shell.
2. They are economical.
3. They are easy to handle and carry.
4. Capsules are made from gelatin hence they are therapeutically inert.

Disadvantage
1. The hygroscopic drug cannot be filled in capsules.

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TYPES OF CAPSULE
Capsules are available in two types:
1. Soft gelatin capsule.
2. Hard gelatin capsule.

SOFT GELATIN CAPSULE

Figure 2 Soft Gelatin Capsule

These are used for administration of liquid medicaments. Soft gelatin capsules are available in
round, oval and tube like shapes. They are made from gelatin. The gelatin is plasticized by the
addition of glycerin and sorbitol etc. the soft gelatin shell may contain a preservative to prevent
the growth of fungi. They are used to enclose liquid medicaments like oils, suspensions, food
concentrates and ophthalmic products.

Filling of soft gelatin capsules:

Soft gelatin capsules are generally filled mechanically. The manufacturing of capsule shell and
the filling of the medicament take place simultaneously. A rotary machine is used for this
purpose.
Rotary machine – In a rotary die machine, the soft gelatin capsules are prepared and
then filled immediately with the liquid medicaments.

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The machine consists of two hoppers. Liquid gelatin mixture is placed in one hopper and
the liquid medicament in the other hoper. There are two rotating die which rotate in opposite
directions. When fluid gelatin mixture enters into the machine from the hopper, it provides two
continuous ribbons. These ribbons come over the rotating dies from opposite directions and enter
in between the dies. Thus, half shell of the capsule is formed. At this stage the measured quantity
of the medicament is filled it with the stroke of a pump. With the subsequent movement of the
dies, the other half of the capsule is formed. The two halves of the capsules are sealed together
by the heat and pressure of rotating die. The capsules formed are washed thoroughly and dried.

Figure 3 Rotary machine

HARD GELATIN CAPSULES

These are used for administration of solid medicaments. The capsule shell is prepared from
gelatin, colour and titanium dioxide to make it opaque. It consists of two parts i.e. body and cap.
The powdered material is filled into the cylindrical body of the capsule and then the cap is filled
into the cylindrical body of the capsule and then the cap is placed over it. The empty capsules are
available in various sizes. They are numbered according to the capacity of the capsules.

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Capsule number

Figure 4 Hard Gelatin Capsule

and its Approximate
Capacity

Capsule number Approximate capacity in mg

000 950

00 650

0 450

1 300

2 250

3 200

4 150

5 100

Excipients used in filling of capsules: While filling solid medicaments in a powder form
into the body of a hard gelatin capsule, the following additives, too, are included in formulation.

1. Diluents: The diluent is needed in certain cases where the quantity of the medicament is
too small in bulk to get it filled in the smallest available capsule size. In such cases,
diluent is added to bring the medicament upto desired bulk. The commonly used diluents
are lactose, mannitol, sorbitol, starch etc.
2. Absorbents: When medicaments are physically incompatible with each other e.g.
eutectic substances or hygroscopic substances. In such cases, absorbents, such as oxides

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and carbonates of magnesium and calcium and kaolin are added to the powdered drug.
These inert materials act as a protective sorbent.
3. Glidants: To ensure a regular flow of powder into the automatic capsule machine
glidants are mixed with medicaments. E.g. talc, magnesium stearate and calcium stearate.
4. Antidusting compounds: During the filling of capsule by and automatic filling machine,
a lot of dust comes out of the machine. The dust is inhaled by operator of machine. It can
pose a serious health hazard if allowed to be unchecked, especially, when the dust of the
potent drugs is inhaled by the workers. To avoid this, some antidusting components, like
inert edible oils, are added to the formulation.

Filling of hard gelatin capsules

The capsule can be filled either by hand or by a semi-automatic device or by an automatic filling
machine.
Capsule filling machine (Hand operated) It consists of:
1. A bed having 200-300 holes
2. A loading tray having 200-300 holes
3. A powder tray
4. A pin plate having 200-300 pins
5. A sealing plate having a rubber top.
6. A lever.
7. A cam handle

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Figure 5 Manual Capsule Filling Machine
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Figure 6 Capsule Section of Industry

The empty capsules are filled in the loading tray and it is placed over the bed. The cam handle is
operated to separate the caps from their bodies. The powder tray is placed in a proper position
and filled with an accurate quantity of powder with scraper. The excess of powder is collected on
the platform of the powder tray. The pin plate is lowered and the filled powder is pressed by
moving the pin downwards. After pressing, the pin plate is raised and remaining powder is filled
into the bodies of the capsules. The powdered tray is removed after its complete filling. The cap
holding tray again placed in position. The plate with the rubber top is lowered and the lever is
operated to lock the caps and bodies. The loading tray is then removed and filled capsules are
collected.

EVALUATION PARAMETERS

1. Uniformity of weight
2. Content of the active ingredient in capsule
3. Disintegration test
4. Dissolution test

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Figure 7 Marketed Preparation of Liquid

INTRODUCTION
Liquid dosage forms are essential pharmaceutical products which involves a mixture of active
drug components and nondrug components (excipients). Liquid dosage forms are prepared by
dissolving the active drug substance in an aqueous or non- aqueous (e.g. glycerin, ether, alcohol)
solvent by suspending the drug in appropriate medium or by incorporating the drug substance
into an oil or water phase. Ex: Suspension, Emulsion, Syrups, Elixirs.
Syrups:

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Saturated solution of sucrose in purified water, sweet viscous preparations. Concentration of

sugar is 66% (w/w). Syrups containing medicinal substances are called medicated syrups and
those containing aromatic or flavored substances are known as flavored syrups
MANUFACTURING

Process - Pharmaceutical syrups are produced by mixing purified water, sweeteners,

active ingredients (API), aromas, flavors and other ingredients (thickeners, etc.). The ingredients
are added by means of metering or dosing systems like flow meters and load cells to one or more
reactors, the order and quantity of the ingredients to add is specified in the recipe. Usually,
preparations are heated before finishing the addition of components. Solid products are added by
means of solid-liquid blenders or vacuum systems. When the process is finished, the end product
is filtered (if required) and sent to a storage tank. The product is transferred from the storage
tanks to the filling machines by pumps.

Solid ingredient
Dosing system Production tank

Liquid ingredient

Filling Machine Storage tank filtration

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TECHNIQUE MONITORING PHYSICAL STABILITY

Multiple light scattering coupled with vertical scanning is the most widely used technique to
monitor the dispersion state of a product, hence identifying and quantifying destabilization
phenomena. It works on concentrated dispersions without dilution. When light is sent through
the sample, it is back scattered by the particles. The backscattering intensity is directly
proportional to the size and volume fraction of the dispersed phase. Therefore, local changes in
concentration (sedimentation) and global changes in size (flocculation, aggregation) are detected
and monitored.

ACCELERATING METHOD OF SHELF LIFE PREDICTION

The kinetic process of destabilization can be rather long (up to several months or even years for
some products) and Figure 8 Liquid Section of Industry it is often required for the

formulator to use further accelerating methods in order to reach reasonable development time for
new product design Thermal methods are the most commonly used and consists in increasing
temperature to accelerate destabilization (below critical temperatures of phase inversion or
chemical degradation). Temperature affects not only the viscosity, but also interfacial tension in
the case of non-ionic surfactants or more generally interactions forces inside the system. Storing
a dispersion at high temperatures enables simulation of real life conditions for a product (e.g.
tube of sunscreen cream in a car in the summer), but also to accelerate destabilization processes
up to 200 times.

Mechanical acceleration including vibration, centrifugation and agitation are sometimes used.
They subject the product to different forces that pushes the particles / droplets against one
another, hence helping in the film drainage. However, some emulsions would never coalesce in
normal gravity, while they do under artificial gravity. Moreover, segregation of different
populations of particles have been highlighted when using centrifugation and vibration.

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INTRODUCTION
Packaging is defined as the collection of different components which surround the
pharmaceutical product from the time of production until its use. Packaging pharmaceutical
products is a broad, encompassing, and multi-faceted task. Packaging is responsible for
providing life-saving drugs, medical devices, medical treatments, and new products like medical
nutritionals (nutraceuticals) in every imaginable dosage form to deliver every type of
supplement, poultice, liquid, solid, powder, suspension, or drop to people the world over. It is
transparent to the end user when done well and is open to criticism from all quarters when done
poorly. Distribution of products is now more global than ever. Mass customization of packaging
to permit its use in multiple markets is a topic that needs exposition and discussion.
Environmental issues, including sustainability, will always be a subjective dimension to any
packaging design. Packaging is an emerging science, an emerging engineering discipline, and a
success contributor to pharmaceutical industries. Packaging can reside, or report through
research and development (R and D), engineering, operations, purchasing, marketing, or the
general administrative department of a company. For the majority of products produced in
pharmaceutical industries it is probably the single largest aggregate purchase made by a
company of materials critical to the protection, distribution, and sale of the product. The
pharmaceutical packaging market is constantly advancing and has experienced annual growth of
at least five percent per annum in the past few years. The market is now reckoned to be worth
over 20 billion a year. As with most other packaged goods, pharmaceuticals need reliable and
speedy packaging solutions that deliver a combination of product protection, quality, tamper
evidence, patient comfort and security needs. Constant innovations in the pharmaceuticals
themselves such as, blow fill seal vials, anti-counterfeit measures, coating technology, , unit
dose vials, two-in-one prefilled vial design, prefilled and child-resistant packs have a direct
impact on the packaging. The review details several of the recent pharmaceutical packaging
trends that are impacting packaging industry, and offers some predictions for the future.

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FUNCTIONS OF PHARMACEUTICAL PACKAGING

1. The containment of the product is the most fundamental function of packaging for
medicinal products. The design of high-quality packaging must take into account both the
needs of the product and of the manufacturing and distribution system. This requires the
packaging: not to leak, nor allow diffusion and permeation of the product, to be strong
enough to hold the contents when subjected to normal handling and not to be altered by
the ingredients of the formulation in its final dosage form.
2. Protection - The packaging must protect the product against all adverse external
influences that may affect its quality or potency, such as light, moisture, oxygen,
biological contamination, mechanical damage and counterfeiting/adulteration.
3. Presentation and information - Packaging is also an essential source of information on
medicinal products. Such information is provided by labels and package inserts for
patients.
4. Identification - The printed packs or its ancillary printed components serves the functions
of providing both identity and information.
5. Convenience- The convenience is associated with product use or administration.

CATEGORIES OF PHARMACEUTICAL PACKAGING MATERIAL

1. Primary packaging system is the material that first envelops the product and holds it
i.e., those package components and subcomponents that actually come in contact with the
product, or those that may have a direct effect on the product shelf life e.g., ampoules and
vials, prefilled syringes, IV containers, etc.
2. Secondary packaging system is outside the primary packaging and used to group
primary packages together e.g., cartons, boxes, shipping containers, injection trays, etc.
3. Tertiary packaging system is used for bulk handling and shipping e.g., barrel, container,
edge protectors, etc.

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MATERIALS USED FOR PHARMACEUTICAL PACKAGING

Traditionally, the majority of medicines (51%) have been taken orally by tablets or capsules,
which are either packed in blister packs (very common in Europe and Asia) or fed into plastic
pharmaceutical bottles (especially in the USA). Powders, pastilles and liquids also make up part
of the oral medicine intake. However, other methods for taking medicines are now being more
widely used. These include parentral or intravenous (29%), inhalation (17%), and transdermal
(3%) methods.

These changes have made a big impact on the packaging industry and there is an increasing need
to provide tailored, individual packaging solutions, which guarantee the effectiveness of
medicines.

The present review article details several key trends that are impacting packaging industry, and
offers some predictions for the future packaging encompassing solid oral dosage forms and
injectables.

RECENT PACKAGING TECHNOLOGY

BLOW-FILL-SEAL TECHNOLOGY

Aseptic blow-fill-seal (BFS) technology is the process by which plastic containers are formed,
filled with sterile filtered product and sealed in an uninterrupted sequence of operations within
the controlled sterile environment of a single machine.

The blow-fill-seal process is a robust, advanced aseptic processing technology, recognized by

worldwide regulatory authorities for its inherent operational advantages over conventional
aseptic production. Blow-fill-seal systems offer a unique combination of flexibility in packaging
design, low operating cost and a high degree of sterility assurance. The machines require a
minimum number of operating personnel and have a relatively small space requirement.

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A variety of polymers may be used in the process, low and high-density polyethylene and
polypropylene being the most popular. The innate ability to form the container/closure during the
actual aseptic packaging process allows for custom design of the container to meet the specific
needs of the application. This flexibility not only improves container ease of use, but provides a
means of interfacing with many of today's emerging drug delivery technologies, most notably in
the field of respiratory therapy.

Container molding

Thermoplastic is continuously extruded in a tubular shape .When the tube reaches the correct
length, the mold closes and the parison is cut .The bottom of the parison is pinched closed and
the top is held in place with a set of holding jaws. The mold is then transferred to a position
under the filling station.

Container filling

The nozzle assembly lowers into the parison until the nozzles form a seal with the neck of the
mold Container formation is completed by applying a vacuum on the mold-side of the container
and blowing sterile filtered air into the interior of the container. The patented electronic fill
system delivers a precise dosage of product into the container. The nozzles then retract into their
original position.

Container sealing

Following completion of the filling process, the top of the container remains semi-molten.
Separate seal molds close to form the top and hermetically seal the container .The mold opens
and the container is then conveyed out of the machine.

The cycle is then repeated to produce another filled container. The filled containers are tested
and checked to ensure that they meet the very strict specifications laid down for such products.

The duration of the complete cycle is between 10-18 seconds, depending on the container design
and the amount of liquid to be filled.

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Advantages of BFS Technology

BFS technology offers considerable advantages over conventional aseptic filling of preformed
(plastic or other) containers, which are described as follows:

1. BFS technology reduces personnel intervention making it a more robust method for the
aseptic preparation of sterile pharmaceuticals.
2. There is no need to purchase and stock a range of prefabricated containers and their
closures. Bulk containers of plastic are required.
3. Cleaning and sterilization of prefabricated containers and closures is not required. A
clean, sterile container is made within the BFS machine as it is required for filling.
4. The cost of material transport, storage and inventory control is reduced.
5. Validation requirements are reduced.
6. The technology allows the design of high-quality, custom-designed containers with
tamper-evident closures in a variety of shapes and sizes.
7. There is a large choice of neck and opening device shapes.
8. A single compact BFS machine takes the place of several conventional machines, saving
floor space. In addition, zones for transport to successive filling and closing procedures
are not required because these operations all take place in the BFS machine itself.
9. The operation of BFS machines is less labor intensive than conventional aseptic filling.
10. The code numbers and variable data such as batch number and expiry date can be molded
into the container itself rather than being added at a subsequent stage.
11. The process lends itself to the production of single dose containers and therefore
preservatives are not necessary as they are with multi-dose containers.

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Blow-fill-seal technology has gained much market focus in recent years due to the increased
focus on biologics, proteins and other complex solutions. These important products often cannot
withstand exposure to high temperatures for extended periods of time without degradation of
their active components. Conventional terminal sterilization, therefore, is not an acceptable
method to produce a ‘sterile’ product. Bulk sterilization, sterilization by gamma irradiation or
filter sterilization followed by direct packaging utilizing the blow-fill-seal process are often used
successfully for these types of products.

BLISTER & STRIP PACKING

Blister packs are commonly used as unit-dose packaging for pharmaceutical tablets, capsules or
lozenges. Blister packs can provide barrier protection for shelf life requirements, and a degree
of tamper resistance. In the US, blister packs are mainly used for packing physician samples of
drug products, or for Over the Counter (OTC) products in the pharmacy. In other parts of the
world, blister packs are the main packaging type since pharmacy dispensing and re-packaging
are not common. A series of blister cavities is sometimes called a blister card or blister strip as
well as blister pack. The difference between a strip pack and blister pack is that a strip pack does
not have thermo-formed or cold formed cavities; the strip pack is formed around the tablet at a
time when it is dropped to the sealing area between sealing moulds. In some parts of the world
the pharmaceutical blister pack is known as a Push-Through-Pack (PTP), an accurate description
of two key properties (i) the lidding foil is brittle making it possible to press the product out
while breaking the lidding foil and (ii) a semi-rigid formed cavity being sufficiently collapsable
to be able to dispense the tablet or capsule by means of pressing it out with the thumb. The main
advantages of unit-dose blister packs over other methods of packing pharmaceutical products are
the assurance of product/packaging integrity (including shelf life) of each individual dose and the
ability to create a compliance pack or calendar pack by printing the days of the week above each
dose. Blister packs are created by means of a form-fill-seal process at the pharmaceutical
company or designated contract packer. A form-fill-seal process means that the blister pack is
created from rolls of flat sheet or film, filled with the pharmaceutical product and closed (sealed)
on the same equipment. Such equipment is called a blisterline. There are two types of blister
machine' design: rotary and flat-plate.

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Figure 9 Strip Packing

Figure 10 Blister Packing

BLISTER/STRIP CHECKING DURING PACKING

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Strip checking person should inspect for empty pocket, and pocket cut, half broken tablet (in
case of blister) and remove defective strip or blister if any. The person should check the printing
for clarity and smudging and appearance of strip and remove defective strip or blister if any.
Checking person should collect the defective strip or blister in a duly label container “Rejected”.
The counting person should count the required no. of blister, and send it to carton filling person.

INTRODUCTION

Quality control, or QC for short, is a process by which entities review the quality of all factors
involved in production. ISO 9000 defines quality control as "A part of quality management
focused on fulfilling quality requirements. This approach places an emphasis on three aspects.
Elements such as controls, job management, defined and well managed processes, performance
and integrity criteria, and identification of records.

Controls include product inspection, where every product is examined visually, and often using
a stereo microscope for fine detail before the product is sold into the external market. Inspectors
will be provided with lists and descriptions of unacceptable product defects such as cracks or
surface blemishes for example.

The quality of the outputs is at risk if any of these three aspects is deficient in any way.

Quality control emphasizes testing of products to uncover defects and reporting to management
who make the decision to allow or deny product release, whereas quality assurance attempts to
improve and stabilize production (and associated processes) to avoid, or at least minimize, issues
which led to the defect(s) in the first place.[citation needed]
For contract work, particularly work

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awarded by government agencies, quality control issues are among the top reasons for not
renewing a contract.

Quality assurance (QA) refers to the planned and systematic activities implemented in a quality
system so that quality requirements for a product or service will be fulfilled. It is the systematic
measurement, comparison with a standard, monitoring of processes and an associated feedback
loop that confers error prevention. This can be contrasted with quality control, which is focused
on process outputs.

Two principles included in QA are: "Fit for purpose", the product should be suitable for the
intended purpose; and "Right first time", mistakes should be eliminated. QA includes
management of the quality of raw materials, assemblies, products and components, services
related to production, and management, production and inspection processes.

Suitable quality is determined by product users, clients or customers, not by society in general. It
is not related to cost and adjectives or descriptors such "high" and "poor" are not applicable. For
example, a low priced product may be viewed as having high quality because it is disposable

where another may be viewed as having poor quality because it is not disposable.

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Figure 11 Process of Quality Control

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PHARMACEUTICAL TESTING INSTRUMENTS

Dissolution Test Apparatus Flame photometer

Disintegration Tester Karl Fischer Moisture Titrator

Bulk & Tapped Density Tester Leak Test Apparatus

Tablet Hardness Tester Melting Point Apparatus

Friability Tester Pyrogen Tele Thermometer

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Fluorometer Figure 12 Testing Instruments

OBJECTIVE
To lay down a procedure for proper identification, storage & handling of Raw & Packing
material.

SOP
SOP shall be applicable for storage and handling of Raw & Packing materials at Stores
Department.

RESPONSIBILITY

Stores Assistant/Officer

ACCOUNTABILITY

Head of Department

PROCEDURE

 After receiving the materials, store person shall unload the materials in staging area and
clean the material (container/packs) with the help of vacuum cleaner/dry lint free cloth
and transfer the material in designated quarantined storage area after physical verification
and affix quarantine label.
 Store person shall record his observation in a Physical verification Record for RM or
Physical verification Record for PM.
 When the material is released by QC, QC person shall affix the “APPROVED” label on
each container/bags and Store person shall transferred the material in designated
approved storage area as per their storage condition.

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STORAGE OF RAW MATERIAL

 If raw material storage limit is 2°C to 8°C, transfer the material in cold storage and daily
record is maintained.
 If material storage limit is below 25°C transfer the material in RM.
 If the material storage condition is not specified store the material in RM Store.
 If the material is rejected by Q.C. dept. it must be shifted to the REJECTED storage area
under lock & key. A logbook of rejected material in this area is to be maintained.
 Information of rejection of the materials should be given to the purchase dept.
 After dispensing, loose quantity of the material should be closed tightly with nylon
thread and shifts it into the original container.
 In case temperature of stores exceeds the limit inform to maintenance for rectification.
 Rejected raw material shall be sent back to the supplier as per the instructions given by
the purchase department.
 If rejected material is destroyed in factory premises, prepare the destruction note and
follow the SOP.

STORAGE OF PACKING MATERIALS

Different packing material to be stored respectively as defined below:

 PRINTED LABELS
After Q. C. Approval, keep all printed label products wise / item codes wise in their
respective cupboards under lock and key.

 PRINTED PACKING MATERIAL

After Q. C. Approval, keep all printed paper packaging material with segregation of item
/ lot wise on racks / Pallets.

 PRINTED / PLAIN ALUMINIUM FOIL/ PVC / PVDC FILM

After Q.C. Approval, keep plain / printed aluminum foil / PVC/PVDC film in Foil
storage room.

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CONCLUSION

Thus at the end I have reach at the conclusion that during at my one month industrial training in
Vibgyor Laboratorie (India), Naini, Allahabad. I have understand the environment of industry
and how much company’s staff do the hard work in production of such a bulk number of
products, and also given me a vast knowledge of Pharmaceutical industry, how one can cope up
with the problem while working in this field.

A Pharmaceutical manufacturing unit is placed where not only been best possible formulations
are prepared to serve the social surrounding but also industrial training program are carried out to
prepare technically skilled manufacturing Chemist and Analyst.

In this industry both the above two functions are carried out under the supervision of well
skilled, experienced and technical persons with complete attention n and honesty that improves
not only growth in profit of industry but also produce best Chemist and Analysts for future .

I wish sharp growth in profile of industry in the coming days and I also admire it to be one of the
best places for producing better Chemist and Analysts beyond the formulation.

My opinion about the industry “Best place for occasionally been noted by someone this is one of
them which is noted by me”

I like the environment, staff’s and Head’s of Departments and heartily wish to work with them
ever when opportunity is given to me.

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