REPORT ON INDUSTRIAL TRAINING - I

A Report Submitted in Partial Fulfillment of the Requirements

of the Degree of
BACHELOR OF PHARMACY

Submitted by

BABLU
ROLL NO. 2008660500011

Under the Supervision of

Mr. RAJAT KUMAR BHARTI
(Assistant Professor)

(A . N . A INSTITUTE OF PHARMACEUTICAL SCIENCES AND RESEARCH, BAREILLY)

Dr. A.P.J ABDUL KALAM TECHNICAL UNIVERSITY

UTTAR PRADESH LUCKNOW (U.P.)

Session 2022-2023

1
 ACKNOWLEDGEMENTS

I am grateful to God for the good health and wellbeing that were necessary to complete this Project.

I wish to express my sincere thanks to Dr. MUSTAQEEM ABDULLAH (Director, A.N.A Institute of
Pharmaceutical Sciences and Research, Bareilly) for providing me with all the necessary facilities for the
Industrial training.

I place on record, my sincere thank you to Mr .Ratandeep Chauhan (Head of A.N.A Institute of Pharmaceutical
Sciences and Research, Bareilly) for the continuous encouragement.

The completion of this undertaking could not have been possible without the participation and assistance of
Faculties of Pharmacy Department. Their contributions are sincerely appreciated and gratefully acknowledged.
However, the group would like to express their deep appreciation and indebtedness particularly to Dr. Rajat
Kumar Bharti (Assistant Professor) for their guidance and co-operating and endless support, kind and
understanding spirit during our thesis presentation. I am extremely thankful and indebted to him for sharing
expertise, and sincere and valuable guidance and encouragement extended to me.

I take this opportunity to express gratitude to all of the Department faculty members for their help and support. I
also thank my parents for the unceasing encouragement, support and attention. I am also grateful to my partner
who supported me through this venture. Above all, to the Great Almighty, the author of knowledge and
wisdom, for his countless love. We thank you…..

BABLU

B.Pharm Third Year

Roll no 2008660500011
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 ENDORSEMENT BY THE PRINCIPAL OF INSTITUTE
This certifies that the report work entitled “ A Report of Industrial Training-I is genuine work done by Bablu
under the guidance of Mr. Rajat Kumar Bharti (Assistant Professor), A.N.A Institute of Pharmaceutical
Sciences and Research Bareilly .

Mr. Rajat Kumar Bharti Dr . Mustaqeem Adullah

(Assistant Professor) ( Director )

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4
 DECLARATION

I declare that I have done industrial training at “G.M.H. LABORATORIES ,BADDI, DISTT-SOLAN
DISTT (H.P.) ''
for 30 days as an Industrial Pharmacist.

I have submitted information above that is true.

It is an authentic record of work carried out me under the guidance of A.N.A INSTITUTE OF
PHARMACEUTICAL RESEARCH & SCIENCE BAREILLY , is being submitted for partial fulfillment f of the
requirement for the award of bachelor degree in B.PHARM .This has not been submitted anywhere else for the
award of any other degree/diploma.

Internal Examinar Signature External Examinar Signature

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 ABOUT OF G.M.H. LABORATORIES ,BADDI, DISTT-SOLAN (H.P.)

GMH Laboratories is a 16 years 10 months old Proprietorship Firm incorporated on 13-Jul-2006, having its
registered office located at Plot No 13, Industrial Area, Bhatoli Kalan, Baddi, Himachal Pradesh. The major
activity of GMH Laboratories is Manufacturing, Sub-classified into Manufacture of Pharmaceuticals Medicinal
Chemical and Botanical Products and is primarily engaged in the Manufacture of Allopathic Pharmaceutical
Preparations.
GMH Laboratories is classified as a Small enterprise in the financial year 2020-21. It has its unit situated at
Baddi, Himachal Pradesh.

ORGANIZATION DETAILS

Name of Enterprise - GMH Laboratories

Type of Enterprise - Small (Financial Year 2020-21)

Organization Type - Proprietary

Date of Incorporation -13-Jul-2006

Major Activity - Manufacturing

Social Category - General

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 Date of Commencement of Production/Business - 18-June 2007

OFFICIAL ADDRESS

Flat/Door/Block No. Plot No 13

Name of Premises/ Building Industrial Area

Village/Town Bhatoli Kalan

Block Baddi

Road/Street/Lane Baddi

City Baddi

State Himachal Pradesh

Pin Code 173205

BRANCH

Baddi, Solon, Himachal Pradesh

GMH Laboratories, Plot No. 13, GMH Laboratories, Baddi, Plot No. 13 Bhatoli-Kalan Industrial Township B,
Baddi, Solon, Himachal Pradesh, 173205

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 CONTENT
1.INTRODUCTION OF INDUSTRIAL PHARMACY
2 .OBJECTIVES OF INDUSTRIAL TRAINING
3.DEPARTMENTS IN PHARMACEUTICAL INDUSTRY

❖ RESEARCH AND DEVELOPMENT DEPARTMENT

❖ QUALITY CONTROL DEPARTMENT
❖ GOOD MANUFACTURING PRACTICES
❖ GOOD LABORATORY PRACTICES
❖ QUALITY ASSURANCE DEPARTMENT
❖ QUALITY ASSURANCE VS QUALITY CONTROL
❖ MICRO DEPARTMENT
❖ PRODUCTION DEPARTMENT
❖ PACKAGING DEPARTMENT

4.PRODUCTION OF TABLET

❖ EXCIPIENTS USED IN TABLET MANUFACTURING

❖ PROCESS OF FORMULATION
Wet Granulation Method
Dry Granulation Method
Direct Compression Method
❖ EQUIPMENTS USED IN FORMULATION
Sifter Equipment
Mixers
Dryers
Compressors
Coating Equipments
Packaging Equipments
Labelling Equipments
❖ QUALITY CONTROL TESTS FOR TABLET
❖ CONCLUSION

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 INTRODUCTION OF INDUSTRIAL PHARMACY
Manufacturing, developing, marketing, and distributing drug goods, as well as ensuring their quality, are all
included in the field of industrial pharmacy.

Current general issues in the pharmaceutical business are the subject of the research. Examples include
formulation and characterization of sticky amorphou
amorphous substances, problem-solving
solving for pediatric medications,
and miniaturization of manufacturing processes.

Using their pharmaceutical expertise, industrial pharmacists monitor drug development to assure precise
production and verify the efficacy and safety oof recently launched medications.

A world where the conditions are favorable for creating novel, secure, efficien
efficient, high-quality,
quality, and reasonably
priced medical products. Make sure that patients have access to the goods and services that Industrial
pharmacists work in companies that essentially manufacture medicines, however there are many different stages
of this process,and pharmacists are involve
involved in most of them.From initial design to public launch

Pharmacists and pharmaceutical scientists, working with other pharmacists and other healthcare professionals,
deliver.

The conversion of raw materials into o certain dosage forms.Or it is manufacturing, development,marketing and
distribution of drug products including quality assurance of these activities .

E.g.: Tablets, capsules, suspensions and nampoule etc.

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 OBJECTIVE OF INDUSTRIAL TRAINING

The objective of the training work is to expose the faculty / students to the working of industry, thereby getting
acquainted with day to day Drug Handling and Manufacturing, Quality Control, Quality Assurance of the
Formulations. They can achieve knowledge by executing hands on training of instruments and job execution.

Main objectives are:

1. To provide students the opportunity to test their interest in a specific career before permanent duties are
made.
2. To develop skills in the application of theory to practical work situations.
3. To develop skills and techniquesues directly applicable to their careers.
4. To build a good communication skill with group of workers and learn to learn proper behavior of
corporate life in industrial sector.
5. The student will be able instilled with good moral values such as responsibility, commitment and
trustworthy during their training.

DEPARTMENTS IN PHARMACEUTICAL INDUSTRY

In this article we will discuss about the four main departments of pharmaceutical industries. The departments
are: 1. Good Manufacturing Practice 2. Good Laboratory Practice 3. Quality Control 4. Quality Assurance.

1. RESEARCH AND DEVELOPMENT DEPARTMENT

Research and development (R&D) is the foundation for discovering innovative medicines and vaccines that
change patients’ lives. Pfizer’s R&D program is designed to develop safe and effective breakthroughs for
patients across the globe

RESEARCH FOR FORMULATION OF NEW DRUG COMPOUND

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E.g.: Discover new drug like Evotaz (atazanavir and cobicistat) tablets for HIV and check its pharmacological
properties then transfer
ransfer to development department to develop the new drug department.

Generally, the R&D process includes basic and translational research, in addition to medicines and vaccine
development:

● Basic research: Investigates the

he biological underpinnings of disease and potential therapeutic targets.
Performed by academic research centers, government agencies, and industry, often in close
collaboration with one another.

● Translational research:: Connects new knowledge about a process or compound to a practical medical
application or therapy. Typically performed by biopharmaceutical companies.

● Medicine and vaccine development: Investigates the safety and efficacy of new medicines and
vaccines through clinical trials.
s. Typically performed by biopharmaceutical companies.

2. QUALITY CONTROL DEPARTMENT

Quality Control is most important part of Quality Team. Quality Control Department is deal with sampling,
specification & analytical procedure preparation & appropriate execution. Quality Control department is also
documentation and release procedures.

This ensures the necessary and relevant tests carried out for the release of products. The product to be released
for sale or supply should be carried out only after checking their quality.

Quality Control is not confined to lab. operations, but it is involved in all decisions which concern the quality.

The independence of Quality Control from production is considered fundamental to the satisfactory operation of
Quality Control.

The basic requirements of Quality Control are as below:

(a) Adequate facilities, trained personnel and approv
approved procedures must be available for sampling, inspecting

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&testing starting materials, packaging materials, intermediate, bulk, and finished products, and where
appropriate monitoring environmental conditions for GMP purposes should be done.

COMPONENTS OF QUALITY CONTROL

Records Batch Inspection And

Sampling

Validation QC Labs

Quality Control

Sampling Retained Samples

(b) Samples of starting materials, packaging materials, intermediate products, bulk products and finished
products are taken by personnel according to the methods approved by Quality Control.

(c) The test method should be validated.

(d) Records are made, manually and/or by recording data on-line. This should demonstrate that all the required
sampling, inspecting and testing procedures were actually carried out. Any deviations from the recommended
norms should be recorded and investigated.

(e) The finished products contain active ingredients complying with the qualitative and quantitative
composition, their storage in proper containers must be done. The containers must be labelled.

(e) The finished products contain active ingredients (a.i.) complying with the qualitative and quantitative
composition, their storage in proper containers must be done. The containers must be labelled.

(f) Inspection and the date of testing of materials, intermediate, bulk, and finished products should be formally
assessed. The products deviations from specified procedures must be checked.

(g) No batch of product is released for sale or supply prior to certification by a qualified person, which is in
accordance with the requirements of the marketing authorization.

(h) Sufficient reference samples of starting materials and products are retained to permit future examination of
the product, if necessary. The product is retained in its final pack unless exceptionally large packs are produced.

QUALITY CONTROL ACTIVITIES

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Quality control activities are carried out to monitor and record the results of quality assurance, measure quality
performance levels and recommend necessary changes (corrective actions) to the overall quality management
plan. Quality control activities serve as a foundation for using continuous improvement approaches throughout
the project implementation process.

The following are examples of activities for quality control:

● Use control measurements to analyze and evaluate the quality standards and processes.
● Perform quality control assessments and audits.
● Compare quality control measurements against established control limits and tolerances.
● Identify non-compliance and reasons for that.

GOOD MANUFACTURING PRACTICE (GMP)

Good Manufacturing Practice (also called ‘current Good Manufacturing Practice’, cGMP’) is a part of Quality
Control this ensures that products are consistently produced and controlled to the quality standards appropriate
to their intended use as required by the marketing authorization or product specification.

Additionally, GMP requires that all manufacturing and testing equipment has been qualified as suitable for use,
and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing)
utilized in the drug manufacturing process have been validated (according to predetermined specifications), to
demonstrate that they can perform their purported functions.

GMP is concerned with both production and quality control. Requirements of GMP ensure that:

(a) All manufacturing processes are clearly defined, systematically reviewed in the light of experience and are
shown to be capable of manufacturing medicinal products of the required quality consistently as per
recommended specifications.

(b) Validation is required for their manufacturing processes.

(c) All necessary facilities including qualified and trained personnel, adequate premises and space, suitable
equipment and services, correct materials, containers and labels; approved proce-dures and instructions and
suitable storage and transport facilities may also be provided for carrying out GMP.

(d) The instructions and procedures are to be written in an instructional form in clear and unambiguous
language. The operators should be trained and the records must be maintained during manufacturing. This
shows that all the steps related to defined procedures were taken into consideration. Thus, the quantity and
qual-ity of the product remain the same in all the concerned batches.

If any significant deviations occur, it must be recorded and investigated. Similarly, records of manu-facturing
including distribution enable the complete history of a batch. This is re-tained in a comprehensible and
accessible form. The distribution (wholesaling) of the products should also minimize any risk to its quality.

The system must be available to recall any batch of product, from sale or supply. If any complaint lodged about
mar-keted products, the causes of quality de-fects should be investigated and appropri-ate measures can be
taken so that the defective products must not be produced in future.

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GMP is a good business tool which helps to refine both compliance and per-formance in manufacturing
company.

People Products

GOOD MANUFACTURING PRACTICES

Procedures

Process Premisses &

Equipment

5 PRINCIPLES OF GOOD MANUFACTURING PROCESS

GMP requirements are largely of common sense practices which will help the manu-facturer so as it moves
towards a quality approach using continuous improvement, shows the creation and maintenance of a GMP
lifestyle in a company to begin with set up of standards of performance.

These include GMP regulations and other standards which are necessary for any company. All the relevant
departments in the company must have trained personnel of GMP and other standards.

In different countries there are different regulatory authorities that enforce to apply the GMPs such as Food and
Drug Authority (FDA) in the United States, the Medicines and Healthcare products Regulatory Agency
(MHRA) in the United Kingdom, the Korea Food and Drug Administration (KFDA) in the Republic of Korea
(South Korea), the Ministry of Health in Iran, India and Pakistan.

Each of the inspectorates carry out routine GMP inspections to ensure that drug products are produced safely
and correctly; additionally, many countries perform Pre-Approval Inspections (PAI) for GMP compliance prior
to the approval of a new drug for marketing.

The regulatory agencies of different countries like the FDA in the US are authorized to conduct unannounced
inspections.

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Some inspections may be scheduled. FDA routine domestic inspections are usually unannounced, but must be
conducted according to 704(A) of the FD&C Act (21USC374). Courts have held that any time the firm is open
for business reasonably for an inspection.

GOOD LABORATORY PRACTICE (GLP)

The laboratory premises and equipment should meet the general and specific requirements for Quality Control
(QC)areas.

The personnel, premises, and equipment in the laboratories should be appropriate to the tasks imposed by the
nature and the scale of the
he manufacturing operations.

Good Laboratory Practice (GLP) is a quality system covering the organizational process and conditions under
which non-clinical
clinical laboratory studies are planned, performed, monitored, recorded, reported, and archived. GLP
ensures the quality and integrity of safety test data submitted to the government for the issuance of research
permits.

(i) Documentation:

Laboratory documentation should follow the standard principles. An important part of this documentation deals
with Quality Control.
ontrol.
The major requirements of QC department are: specifications for the laboratory, sampling procedures of the
item, and testing procedures (including analytical worksheets and/or laboratory notebooks). Minimum
Availability in of Documents In Quality control department as per given below ;

● Specifications.
● SOP for Sampling, Testing, Records ( Including test worksheets & Laboratory notebooks format ),
Recording and verifying ;
● SOP for calibration/qualification of instruments and Maintenance of Equipment also department should
maintain Records of the same.
● SOP of investigation of out of specification and out of Trend results.
● testing reports and/or certificates
ficates of analysis.

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 ● Data from environmental (air,water & other utilities ) monitoring, where required;

(ii) Sampling:

The sampling taking should be done in accordance with approved written procedures. The method of sampling,
the equipment to be used, the amount of the sample to be taken and any othe
otherr type of instructions the type and
condition of the sample container besides precautionary measures especially with regard to the sampling of
sterile or noxious materials must be considered. The instructions for the cleaning and storage of sampling
equipment should also be mentioned.

(iii) Testing:

The testing procedure comprises of analytical methods. The analytical methods should be validated. All testing
operations described in the marketing authorization should be carried out according to the recommendation.
recommend The
results should be recorded and checked to make sure that they are reproducible.

The tests performed should be recorded and the records should include the important data such as:

(a) Name of the material or product and, where applicable, dosage fform,

(b) Batch number and, where appropriate, the manufacturer and/or supplier,

(c) References to the relevant specifications and testing procedures,

(d) Test results, including observations and calcula-tions, and reference to any certificates of analysis,

(e) Dates of testing,

(f) Initials of the persons involved in testing,

(g) Initials of the persons verified the testing and the calculations and

(h) A clear statement of release or rejection of the product (or other status) and the signature of the designated
design
responsible person with date.

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Good Laboratory Practice Examples

Below are general Good Laboratory Practice examples:

● Wear Personal Protective Equipment (PPE) at all times.

● Communicate with other members of the research lab.
● Participate in refresher training
raining and safety exercises.
● Be aware of what you’re doing at all times.
● Pay attention to unfamiliar smells and substances.
● Use the right lab equipment for the task or activity.
● Regularly clean, calibrate, and maintain equipment.

4. QUALITY ASSURANCE (QA):

Quality Assurance is a wide ranging concept which covers all matters individually or collectively that influence
the quality of a product. It is the sum or total of the organized arrangements made with the object of ensuring
the medicinal products aree of the quality required for their intended use.

Therefore, Quality Assurance includes GMP. In a pharmaceutical production process, quality assurance is
involved in several activities such as: purchasing, dispatching, warehousing, operational protocols,

manufacturing,
anufacturing, training, quality control, validation and packaging.

A quality assurance is considered by merging a series of actions. These actions collectively ensure product
quality. As a result, the quality assurance system must establish specific activ
activities
ities before the start of production.

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This also includes the control factors and product evaluation before formation of final product. The system of
Quality Assurance for the manufacture of medicinal products should ensure that the products are designed and
developed in a way that follows the requirements of GMP and GLP.

The production and control operations are clearly specified and GMP has been adopted. The managerial
responsibilities must be clearly specified and arrangements made for the manufacture, supply and use of the
starting, and packaging materials should also be taken care of. All necessary controls or intermediate products,
and any other in-process controls and validations must be carried out.

Finally, the finished product should be correctly processed and checked according to the defined procedures. It
is important to mention that the medicinal products are not sold or supplied before a qualified person certified
each production batch in accordance with the requirements of the marketing authorization, and any other
regulations relevant to the production, control and release of medicinal products.

The satisfactory arrangements exist to ensure that the medicinal products are stored, distributed and
subsequently handled so that quality is maintained throughout their shelf life. On the other hand, there is a
procedure for self-inspection and/or quality audit which regularly appraises the effectiveness and applicability
of the Quality Assurance system.

There are several objectives that must be met with pharmaceutical quality assurance. If a manufacturer falls
short of these objectives, they may face heavy fines and possible legal actions that can jeopardize the business.

Today, we’re going to go over the common objectives of pharmaceutical importance. Understanding these
objectives will shed light on how important pharmaceutical quality assurance truly is.

Objectives of Pharmaceutical Quality Assurance

There are several objectives of pharmaceutical quality assurance that must all be met. If an organization is
unable to meet these quality objectives, it will need to revisit the entire pharmaceuticals manufacturing process.
Below are each of the primary objectives that every quality assurance program must strive to meet.

Ensure The Public’s Safety

The ultimate objective of any pharmaceutical manufacturer is to create a product that will keep the public safe.
A properly manufactured medication has the potential to greatly improve someone’s life. Creating a quality
product has a profound impact on the overall health and well-being of society.

However, if quality assurance is not up to par, the medication that should be saving someone’s life can end up
threatening it or causing irreversible harm. Every team member involved in pharmaceutical quality assurance
should always keep the person taking the medication in mind.

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Strict quality control is required to meet this objective. This includes thorough employee training, continuous
improvement of quality management systems, minimizing or eliminating deviation, documenting control,
carrying out internal audits, and periodic management reviews.

Protect Against Negative Publicity

In the perfect world, the public would love your organization and be grateful that you’re manufacturing life-
saving medications. However, the pharmaceutical industry has seen its share of scandals over the years that
have shaken public confidence.

Your ultimate goal should be to gain public confidence, but short of that, the objective is to protect against
negative publicity. Having a robust quality assurance system in place will ensure that every drug that’s shipped
is safe and effective. Following good manufacturing practices (GMP) and implementing quality inspection
policies will help drug manufacturers produce only the highest quality products.

If your organization focuses on the first objective, keeping the public safe, then you should naturally protect
against negative publicity.

Continually Increase Production Efficiency

Quality assurance is largely about ensuring that a quality product is being shipped. The second aspect of quality
assurance is that it allows your organization to regularly examine the entire manufacturing process, from raw
material inspection to product development.

Companies must find ways to innovate to become more efficient at manufacturing drugs, but they shouldn’t do
this at the risk of quality. Every relevant regulation must be adhered to while simultaneously efficiently
producing medications.

Consider that technologies now exist that allow for many of the production processes to become automated.
While embracing this change may seem like it’s focused on increasing production, it also provides
manufacturers with tighter control on each stage of production.

Guarantee Compliance

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Every drug manufacturer must be able to prove that they are in compliance with any relevant regulations. A
robust and thoroughly documented quality assurance system will help drug manufacturers prove that they are
meeting regulatory compliance requirements.

Many compliance issues that companies face are not the result of intentional wrongdoing, but instead, the result
of poor workflows, human error, or lacking collaboration. Focusing on quality assurance will have the
inevitable result of examining each of these factors. Workflows must be examined to prove quality, and
increased good manufacturing practices training will help reduce human error.

The Importance of Quality Assurance Training

If medication fails to work as intended or is defective, it can safely be considered a threat to public health. All
pharmaceutical companies must strive to ensure that all manufactured drugs are free from contaminants and will
achieve their intended purpose. There are several methods and practices used throughout pharmaceutical
manufacturing to guarantee the quality of the end result, and all of them begin with training.

One example is drug stability testing, which measures how various properties of a medication change when
exposed to various conditions. Training your quality assurance personnel on how to carry out this type of testing
will help the quality assurance team understand how the drug should be stored.

We’ve mentioned compliance before, and it bears repeating again. Staying in compliance is one of the primary
objectives of any drug manufacturer. However, how can the quality assurance department be expected to stay in
compliance if they do not receive proper training?

Every employee involved with drug manufacturing should receive the appropriate training that will allow them
to ensure compliance. Learning about good manufacturing practices, for example, will help employees ensure
that they are following the best manufacturing practices at every stage.

QUALITY CONTROL VS QUALITY ASSURANCE

Even though the terms quality control and quality assurance are sometimes used interchangeably, they have
some key differences. Quality criteria, such as ensuring an item complies with specifications, are the main
emphasis of quality control. Quality assurance is the sum of all processes and actions necessary to demonstrate
that the requirements for quality are satisfied.

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Because of this distinction, quality specialists may eventually change their specialization as they progress in
their careers from quality assurance too quality control. For upper management, customers, and government
inspectors, quality assurance programs and departments make sure that products adhere to all quality
requirements and safety regulations. A part of quality assurance is quality control.

MICROBIOLOGY DEPARTMENT

The most important contribution of microbiology to the pharmaceutical industry is the development of
antibiotics. All antibiotics were originally the products of microbial metabolism, however the recent genetic
manipulations have enabled led the production of more enhanced drugs.

Vaccines are also a very important contribution of microbiology towards development of drugs. The production
of vaccines against bacterial diseases usually requires the growth of large amounts of bacteria. Steroids
St can also

be obtained from microorganisms.

Apart from drugs and bio products development, microbiology contributes towards quality control of a
pharmaceutical laboratory. Prevention of microbial contamination of drugs, injectables, eye drops, nasal
solutions and inhalation products is undertaken following pharmacopeial guidelines.

Microbiological Test Methods

Microbiological tests for pharmaceuticals fall into several categories.

The Growth Promotion test

The growth promotion test is an important quality control function in the pharmaceutical industry. It is
imperative for establishing the ability and nutritive property of any media used to support growth when the
inoculum contains a small number of microorganisms.

Sterility Testing.
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Sterility testing is done on wide range of pharmaceutical products as parental preparations, ophthalmic & other
non-injectable preparations, bulk solids and liquid solutions, antibiotic solids, and medical consumables and
devices.

Microbial Limits Test

This test is used to estimate the total number of viable microorganisms or specific pathogens present in
pharmaceutical products as tablets, capsules, oral suspensions, injectables, ophthalmic and nasal solutions and
other medical devices.

It is based on the principle that any viable microbial cell present in a sample will produce a single colony when
provided with a growth medium and favourable growth conditions.

The enumeration of these colony-forming units (cfu) gives an estimate of the microbial population of the
product. The microbial content of the product includes the total bacterial count (TBC), total yeast and mold
count (TYMC). These tests are mandatory for the release of drug products.

Bioburden Testing

Bioburden of raw materials and finished pharmaceutical products helps to determine whether the product
complies with the requirements of the US Pharmacopeia. Bioburden is the total number of microorganisms
present on a product prior to sterilisation.

Water Testing

Water is one of the major commodities consumed by the pharmaceutical industry. Total viable count is studied
to rule out microbial contamination. Tests for presence of coliforms, E. coli and any other pathogens as
Pseudomonas sp. Clostridia, Salmonella, Staphylococcus etc.are performed.

Bacterial Endotoxin (LAL Testing)

Endotoxins are natural compounds released by the cell wall of gram negative bacteria that are potentially toxic
to humans. This material is pyrogenic (causing high fevers in humans). The test for bacterial Endotoxin is used
to detect or quantify endotoxins using Limulus Amoebocyte Lysate (LAL) which is an extract of blood cells
from the horseshoe crab (Limulus polyphemus)

Drug quality and safety is the most important aspect of microbiological testing pharmaceutical products. The
presence of any pathogenic bacteria, yeasts, moulds or bacterial toxins produced by microorganisms is strictly
regulated to ensure prevention of any risk.

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PRODUCTION DEPARTMENT

The process of Drug Manufacturing performed in Production Department in Pharmaceutical Unit into a series
of unit operations, such
ch as dispensing, granulation, coating, tablet pressing, blistering, mixing, filling
f etc.

Guidelines for Production

Production should be performed and supervised by competent people.All handling of materials and products,
such as receipt and quarantine, sampling, storage, labelling, dispensing, processing, packaging and distribution
should be done in accordance with written procedures or instructions and, where necessary, recorded.

● All incoming materials should be checked to ensure that the consignment ccorresponds
orresponds to the order.
Containers should be cleaned where necessary and labelled with the prescribed data.

● Damage to containers and any other problem which might adversely affect the quality of a material
should be investigated, recorded and reported to the Quality Control Department.

● Incoming materials and finished products should be physically or administratively quarantined

immediately after receipt or processing, until they have been released for use or distribution.

● Intermediate and bulk products purchased as such should be handled on receipt as though they were
starting materials.

● All materials and products should be stored under the appropriate conditions established by the
manufacturer and in an orderly fashion to permit batch segregation and sstock
tock rotation.

● Checks on yields, and reconciliation of quantities, should be carried out as necessary to ensure that there
are no discrepancies outside acceptable limits.Operations on different products should not be carried out
simultaneously or consecutively
ively in the same room unless there is no risk of mix
mix--up or cross

23
 contamination.

● At every stage of processing, products and materials should be protected from microbial and other
contamination.

● When working with dry materials and products, special precau

precautions
tions should be taken to prevent the
generation and dissemination of dust. This applies particularly to the handling of highly active or
sensitizing materials.

● At all times during processing, all materials, bulk containers, major items of equipment and where
wh
appropriate rooms used should be labeled or otherwise identified with an indication of the product or
material being processed, its strength (where applicable) and batch number. Where applicable, this
indication should also mention the stage of product
production.

● Labels applied to containers, equipment or premises should be clear, unambiguous and in the company’s
agreed format. It is often helpful in addition to the wording on the labels to use colours to indicate status.
status

● Checks should be carried out to ensure that pipelines and other pieces of equipment used for the
transportation of products from one area to another are connected in a correct manner.

● Access to production premises should be restricted to authorised personnel.

PACKAGING DEPARTMENT

Pharmaceutical packaging (or drug packaging) is the packages and the packaging processes for pharmaceutical

preparations. It involves all of the operations from production through drug distribution channels to the end
consumer.

The Role of Packaging in the Pharmaceutical Industry

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Calling packaging a matter of life and death sounds dramatic in most cases, but if you’re speaking of
pharmaceutical packaging, the phrase rings true. Packaging plays an extremely important role in the
pharmaceutical industry, serving a variety of crucial functions that are linked to consumer protection.

Packaging Protects Pharmaceuticals from Physical Damage

One of the most obvious functions of pharmaceutical packaging is protection against physical damage as a
product moves through the supply chain. Medication that has been crushed, broken, or spilled during transport
is useless to a patient. Pharmaceutical packaging is instrumental in preventing such incidents.

Packaging Protects Pharmaceuticals from Quality Degradation

Many pharmaceutical products can be compromised by environmental factors like light or air. A compromised
pharmaceutical product may fail to perform its intended function, leading to dangerous consequences for
patients. Packaging plays a critical role in combating external elements, preventing chemical alterations and
thus preserving the efficacy of medications.

Packaging Provides Product Information

If misused, pharmaceutical products can cause more harm than good to patients. Pharmaceutical packaging is a
perfect medium for communicating vital drug facts like dosage instructions and product warnings; it allows
patients to use medications in a safe and informed manner.

Pharmaceutical packaging also allows for serialization and aggregation. Serialization is the assignment of a
unique serial number to each sellable prescription product unit. This serial number provides information about
the product’s origin, batch number, and validity date. Counterfeit and substandard drugs pose a major threat to
public health, which is why serialization is so important in the pharmaceutical industry.

Pharmaceutical Packaging Protects Children

Children are known for eating things that they shouldn’t. If a child gets into a parent’s medication, the results
could be deadly. Pharmaceutical packaging companies manufacture child resistant packaging to prevent this
kind of tragic accident.

PRODUCTION OF TABLET
A tablet (also known as a pill) is a pharmaceutical oral dosage form (oral solid dosage, or OSD) or solid unit
dosage form. Tablets may be defined as the solid unit dosage form of medication with suitable excipients.

It comprises a mixture of active substances and excipients, usually in powder form, that are pressed or
compacted into a solid dose. The main advantages of tablets are to ensure a consistent dose of medicine that is
easy to consume.

RAW MATERIALS /EXCIPIENTS USED IN TABLET MANUFACTURING

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Pharmaceutical excipients are ingredients other than the active pharmaceutical ingredient (API) present in a
finished pharmaceutical drug formulation. These are frequently used as lubricants, diluent, binders, flavorings,
coating and coloring agents for the formulation.

Excipients used in the formulation of tablets

i. Binders

Binders also referred to as granulators or granulating fluid, are polymeric, natural or synthetic materials that
impart cohesive qualities to powdered materials used in tablet manufacture. They ensure the tablets remain
intact after compression, as well as improve the free-flowing qualities of the powdered materials without
retarding disintegration or dissolution.

Binders are used alone or in combination with one another. They are added as dry powders (e.g., cellulose and
polyvinyl pyrrolidone) or in the form of their solution that is, by dissolving it in a suitable and appropriate
solvent.

The quantity used has considerable influence on the properties of the compressed tablets. The use of excessive
binder will make a hard tablet that will not disintegrate easily when the tablet comes in contact with moisture
and will also cause excessive wear of punches and dies.

Binders must be non-toxic and must have a good compatibility profile. Materials commonly used as binders
include acacia gum, hydroxypropylmethylcellulose, tragacanth, polyvinyl pyrrollidone (PVP), corn starch,

ii. Bulking Agents/ Diluents/ Fillers

These are approved excipients added to any tablet formular when the quantity of active pharmaceutical
ingredient is very small. They are added to increase the size of the tablets to get a significant tablet weight that
can be handled or compressed, thereby rendering the manufacturing process more reliable and reproducible.
The quantity of bulking agent that appears in a formula is normally determined by the quantity of the drug, the
nature and amount of other ingredients in the formulation.

Bulking agents must be approved like all other raw materials used in tablet formulation. They should be
chemically inert, non-hygroscopic, hydrophilic and must exhibit good compression properties. The
compatibility of the bulking agent with the drug substance must be considered as studies have shown that some
interfere with the absorption of drug substances from the gastrointestinal tract e.g., calcium salts used as bulking
agent for the broad-spectrum antibiotic tetracycline.

Lactose is a common bulking agent used in both tablet and capsule formulations as it fulfils most of the ideal
characteristics of bulking agents. It is unsuitable for patients who are lactose intolerant. Other examples of
bulking agents used in tablet manufacture include mannitol, dicalcium phosphate, calcium sulfate, dry starch,
cellulose, kaolin, sodium chloride, anhydrous lactose, sorbitol, sucrose etc.

iii. Disintegrants
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Disintegrants or disintegrating agents are raw materials that appear in some tablets. They are added to
formulations to overcome the cohesive strength imparted during compression, thus facilitating the breakdown of
the tablet into granules for ready drug availability once they come in contact with moisture. There is still a lack
of understanding with respect to the mechanisms by which disintegrants elicit their functions.

Disintegrants such as starch, sodium starch glycolate and microcrystalline cellulose may enable tablet
disintegration by increasing the porosity and wettability of the compressed tablet matrix. Croscarmellose
sodium, crospovidone, sodium starch glycolate and pregelatinized starch swell in the presence of aqueous
fluids, thereby facilitating tablet disintegration due to the increase in the internal pressure within the tablet
matrix. Tablet disruption following gas production (carbon dioxide) as seen in effervescent tablets is another
mechanism used to enhance tablet disintegration.

Disintegrants may be added intragranular, extragranular or both (which may be varied to achieve the best
result). It does not always mean that the higher the concentration of disintegrants the faster the rate of
disintegration.

The concentration may have a direct relationship with the rate of disintegration until it gets to maximum after
which disintegration rate decreases with increase in concentration of disintegrants.

Factors that influence the actions of disintegrants

Various factors have been identified to influence the actions of disintegrants and they include:

● The amount/ concentration of the disintegrant in the formular.

● The type of disintegrant used.
● The influence of co-excipients (binder, lubricants etc).
● Presence of surfactants/ surface acting agents.
● The nature of the drug substance itself.
● Particle size and particle shape.
● Mixing type, size and time.
● Compressional pressure used during tablet manufacture/ Tablet hardness.

Example of disintegrants used in the manufacture of tablets include corn and potato starches, cation-exchange
resins, Veegum HV, alginic acid, agar, bentonite, natural sponge, guar gum, citrus pulp, methylcellulose,
carboxymethylcellulose etc.

A group of materials known as “super disintegrants” have gained popularity as disintegrating agents. Compared
to the more traditional disintegrants, super disintegrants act extraordinarily fast in exploding tablets in seconds.
Their likely mechanism of action is a combination of proposed theories including water wicking, swelling,
deformation recovery, repulsion and heat of wetting.

Super disintegrants comprise three groups namely:

1. Modified starches
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 2. Modified cellulose
3. Cross-linked povidone

Examples of super disintegrants include croscarmellose, locust bean gum (at 10% w/w), crospovidone, sodium
starch glycolate (Primojel, Explotab) etc.

iv. Lubricants

Lubricants as the name suggest, reduce friction between the powder mix and the die walls during compression
and ejection. They also prevent the mixed powders/ granules from sticking to the processing zone of the tablet
press especially the punches and die. In some cases, lubricants reduce inter-particulate friction and thus,
improve flow rates of powders or granules. The best lubricants are those with low shear strength but strong
cohesive tendencies perpendicular to the line of shear.

Lubricants can be classified based on their solubility characteristics into

● Soluble lubricants e.g., Polyethylene glycol (PEG), Polyoxyethylene stearates, and Lauryl sulphate salts.
● Insoluble lubricants e.g., Magnesium stearate, glyceryl behenate, stearic acid, glyceryl palmitostearate
etc.

v. Flavours and Sweeteners

Sucrose is the most commonly used sweetening agent. Other examples include acesulfame potassium,
aspartame, glucose, dextrate, dextrose, fructose, mannitol, maltose, alitame, isomalt, saccharin, sorbitol,
sucralose, and xylitol.
Flavours are substances that provide sensory characteristics to food. In addition to being directly related to odor,
they play a key role in how a particular food tastes.They include almond, anise, celery, cassia or cinnamon,
clove, lemon, nutmeg, orange, rosemary, savory, basil, sweet marjoram, thyme, and wintergreen.

UNIT OPERATIONS (THE PROCESSES OF FORMULATION)

There are three methods by which tablets are manufactured;

● Wet granulation
● Dry granulation (Slugging)
● Direct compression

Manufacturing process depends on many factors, including the compression properties of the therapeutic
agents, the particle size of the therapeutic agent, excipients and the chemical stability of the therapeutic agent
throughout the producing method.

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(A) WET GRANULATION METHOD

It is most commonly used method for the manufacturing of tablets.

● Water is frequently used as the granulation fluid (and heat is employed to dry the formed granules), it is
important to ensure that the therapeutic agent is chemically stable during the granulation process.
● The wet granulation exhibit sufficient mechanical properties to be subsequently exposed to other unit
operations, Eg: film coating.

Tablet quality is directly affected by the choice and concentration of binder and the type and volume of
granulation fluid. Due to the number of unit operations to the required, the manufacture of tablets by wet
granulation is not as efficient as other methods. Eg: direct compression.

DRY GRANULATION

When tablet ingredients are sensitive to moisture and unable to withstand elevated temperature during drying
and when the tablet ingredient have insufficient cohesive properties, slugging may be used to form granules.

This technique is used in preparation of aspirin, aspirin combination, and acetophenetidin.

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DIRECT COMPRESSION

● Wet granulation and dry granulation methods having series of unit operations, both time consuming and
potentially costly.

● Potentially more attractive option for the manufacture of tablets involves powder mixing and subsequent
compression of the powder mix, thereby obviating the need for granulation. This process is called direct
compression.

The mechanism of particle-particle

particle interactions in tablets produced by direct compression are similar to those operative
in tablets produced by dry granulation and roller compaction.

EQIPMENTS USED IN FORMUATION

1.SIFTER

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Sifter is used to separate the mass composition of solids, liquid from solid, and grade the material as per particle
size. It is a type of pharmaceutical machine used for the separation of pharmaceutical solids or liquids.

VIBRATORY SIFTER

2. MIXERS

The various type of pharmaceutical mixer are used in performing more than one function with capability such
as suspending solids in a liquid, blending, emulsifying liquids, dissolving polymers, powders and granular.

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 PLANETARY MIXER BIN BLENDER

MASS MIXER

3. DRYERS

Dryers are used in a variety of industries, such as the food processing, pharmaceutical, paper, pollution control
and agricultural sectors. Diverse materials need to be dried in completely different businesses, such as
chemicals for research and medical concerns, paper for printing and packaging operations and edible materials
for further processing into popular foods and snacks.

Dryers are used to remove liquids or moisture from bulk solids, powders, parts, continuous sheets or other
liquids by evaporation or sublimation. Dryers can be broken up into two mmain
ain types: direct and indirect.
Direct dryers convectively heat a product through direct contact with heated air, gas or a combusted gas
product. Indirect dryers conductively heat a product through contact with a heated wall.

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 FLUIDIZED
UIDIZED BED DRYER TRAY DRYER

4. COMPRESSORS

Compression Machine (also referred to as Tablet press machine, tablet making machine, tablet machine, or
tablet punching machine) is a mechanical device that is used to compress the granules or mixture of API and
excipients to uniform and predetermined size, shape, and weight of tablets for research, pilot-scale,
pilot and full
production.

SINGLE LAYER TABLET COMPRESSES MULTIPLE TABLETS PUNCHING MACHINE

5. COATING EQUIPMENTS

Tablet coating machines are used to coat the surface of tablets with a thin coating of film. The film is employed
mostly to: mask the colour, taste and smell of the drug. protect the drug from physical or chemical harm.

SUGAR COATING MACHINE FILM COATING MACHINE

6. PACKAGING EQIPMENTS

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Packaging machinery is used throughout all packaging operations, involving primary packages to distribution
packs. This includes many packaging processes: fabrication, cleaning, filling, sealing, combining, labeling, over
lapping and palletizing

STRIP PACKAGING MACHINE BLISTER PACKAGING MACHINE

7. LABELING EQUIPMENTS

Drug labelling is also referred to as prescription labelling, is a written, printed or graphic matter upon any drugs
or any of its container, or accompanying such a drug. Drug labels seek to identify drug contents and to state
specific instructions or warnings
ings for administration, storage and disposal.

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 WET GLUE LABELLING MACHINE SELF ADHESIVE STICKER LABELLING MACHINE

QUALITY CONTROL TESTS FOR TABLETS

Different types of tests are performed due to

● To ensure safety,potency,efficacy,stability,patient acceptability and patient compliance of tablet.

● To check whether a pharmaceutical tablet satisfy certain standards to claim it to be a quality drug or not .
● To check that the quality parameters are with in the acceptance limits or not.

Official Tests

1. Weight Variation Test

In this test, samples of 20 tablets are removed from a batch from time to time during compression, and then are
weighed to determine whether
hether they conform to the required weight criteria. There still may be a difference in
the individual weights even when 20 tablets show the expected total weight.

2.Friability test

Tablet friability testing involves weighing the sample of tablets and the
thenn placing them into a rotating drum. The
drum is then rotated 100 times. The sample is then reweighed to find the % weight loss.

3. Disintegration test

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The disintegration test is used to show how quickly the tablet breaks down into smaller particles, allowing for a
greater surface area and availability of the drug when taken by a patient.

DISINTEGRATION TESTER FRIABILITY TESTER

CONCLUSION
In the end I am glad to tell you that training in “G.M.H. LABORATORIES , BADDI,DISTT. SOLAN (H.P.) ''
for 30 days as a Industrial Pharmacist was an excellent and fabulous experience.

During the training I actually learned about the Pharmaceutical compa

company
ny and above its working the theoretical
knowledge is worth for getting a degree, and it is accessible in the book. We can only imagine about the thing
we read, but practical life is always different and excellent one.

During My training period, I had seenn the various instruments and apparatus in the industry. The highly
sophisticated instruments that work precisely must be operated with intense care for optimum use. We could
acquire a lot of information regarding the latest instruments and their working pprocedures.
rocedures.

Similarly from practical point of view a pharmaceutical company is very difficult. During the training session I
tried to my level best to gain practical knowledge as much as I can. I improved my basic classified doubts and
also understood the importance of maintaining of quality of products at Pharmaceutical company.

I was successfully able to complete my short venture of training. Lastly I hope that my training report fulfill the
intended requirements.
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