GMP

Good
Manufacturing
Practice
 What is GMP?
Good Manufacturing Practice (GMP)
is a system for ensuring that products are
consistently produced and controlled
according to quality standards. Good
manufacturing practices (GMP) are the
practices required in order to conform to
the guidelines recommended by agencies
that control the authorization and
licensing of the manufacture and sale of
food and beverages, cosmetic, pharmaceu
tical products dietary supplements and
medical devices. 
What is GMP?
It is designed to minimize the risks involved in any
pharmaceutical production that cannot be eliminated
through testing the final product. GMP is governed by
the Food and Drug Administration (FDA) to ensure the
safety and integrity of drugs.
GMP covers all aspects of production from the
starting materials, premises, and equipment to the
training and personal hygiene of staff. Detailed written
procedures are essential for each process that could
affect the quality of the finished product. There must
be systems to provide documented proof that correct
procedures are consistentlyfollowed at each step in the
manufacturing process - every time a product is made. 
Why GMP is important?

• Poor quality medicines are not only a health hazard, but a waste
of money for both governments and individual consumers.
• A poor quality medicine may contain toxic substances that have
been unintentionally added.
A medicine that contains little or none of the claimed ingredient
will not have the intended therapeutic effect.
• Most countries will only accept import and sale of medicines that
have been manufactured to internationally recognized GMP.
Governments seeking to promote their countries' export of
pharmaceuticals can do so by making GMP mandatory for all
pharmaceutical production and by training their inspectors in
GMP requirements.
Avoids poor quality medicines
Saves waste of money 
Helps boost pharmaceutical export opportunities
Reduces and prevents errors
Prevents toxicity
Prevents mislabeling
Avoids adulteration
 General requirements of
gmp

• Avoid risks and possibilities of mix-up at all stages

of manufacturing ,labeling package and testing.
• Comfort of the personnel working and regular
monitoring of temperature and humidity,particle
count,DOP(dispersed oil particule ) testing etc.
• Proper drainge system which prevents
backflow.Avoid open channels and if provided
must be able to clean and disinfect.
• Buildings shall be designed,constructed,adapted
and maintained to permit production of drugs
under hygienic conditions.
 General requirements
of gmp
• The factories for manufacture of drugs shall be so
situated that it avoid risk of contamination from
external enviromental including open
sewage,drain,public lavatory.
• Buildings must be well illuminated, effectivel
ventilated with proper air handling units.
• Water shall be stored in tanks, which do not
adversely affect quality of water and ensure
freedom from microbiological growth.
• The tank shall be cleaned periodically and records
maintained by the license in this behalf.
 1.Desing and
2. Following the
construct the
written procedures 3.Document work.
facilities and
and ınstructions.
equipments properly.

10 Basic 4.Validate work.

(confirm)
5. Monitor facilities
and equipment.
6. Write step by step
operating procedures
and work on

Principles of intstructions.

GMP 7.Design, develop

9. Control
8. Protect against components and
and demonstrate job
contamination. product related
competence .
processes.

10. Conduct planned

and periodic audits.
 Imagine this scenario: you work for a pharmaceutical
company and have just purchased a product and need to
find a manufacturer to make this product for you. Your
boss has just told you to find a GMP certified

Facilities and
manufacturer. Sounds easy enough, but what exactly is a
GMP certified manufacturer and why do you need one?

cGMP
The acronym stands for Good Manufacturing Practices,
and to be GMP certified means that the manufacturer
has demonstrated a strong regulatory commitment and
compliance to international GMP standards
4 Key
Considerations Is the manufacturer registered with the Food
and Drug Administration (FDA)?It’s a simple

for Choosing a
process for anymanufacturer to do and it’s the
baseline fact to check off the list.

Pharmaceutica
l Contract
Manufacturing Has the facility been inspected by the FDA,
preferably within the last two years?
Facility Manufacturing facilities need to prove to the
FDA that they have a facility in compliance
with current GMP standarts (cGMP) The
specific inspection group is the CDER Group
(Center for drug Evaluation and research) or the
 FDA Office of Compliance.  Their inspectors will
do a full systems-based cGMP inspection on
that facility.
 What is the facility’s FDA rating? Once the FDA inspectors have
completed their inspection, the facility is rated. The FDA rates facilities

4 Key
with three types of classifications:

Considerations VAI - which is Voluntary Action Indicated; this is a good rating

for Choosing a
Pharmaceutica NAI - which is No Action Indicated; this is also a good rating

l Contract OAI - this is not a good rating. If a facility gets an OAI rating it means
there’s been some objectionable activities or there are systems that are

Manufacturing
deficient. In all OAI cases, the FDA is looking for improvements or
changes to that facility before the rating can be upgraded.

Facility Does the facility have an FDA acceptance letter?

SOME OF
THE MAIN Unexpected contamination of products, causing damage to
Insufficient
Incorrect labels
or tooon
much
containers,
active
health ingredient,
which
or even could
death. resulting
mean that
in in

RISKS
effective
patients treatment
receive theorwrong
edverse
medicine.
effects.
 cGMP
( current good manufacturing practices)
 cGMP refers to the current good manufacturing
practice regulations enforced by the US Food Drug
Administration (FDA).

what are cGMP provide for systems that assure proper design,
cGMPs? monitoring and control of manufacturing processes
and facilities.

Adherence to the cGMP regulations assures the

identity, strength, quality and purity of drug products
by requiring that manufacturers of medications
adequately control manufacturing operations.
 A consumer usually cannot detect ( through smell,
touch, sight) that a drug product is safe or it will
work.

Why are
cGMP so While cGMPs require testing, testing alone is not

important?
adequate to ensure quality.

In most instances testing is done on a small sample

of a batch ( for example, a drug manufacturer may
test 1000 tablets from a batch contains 2million
tablets) so that most of the batch can be used for
patient rather than destroyed by testing.
The Six Components of GMP

• Quality • Production • Laboratory

• Facilities & • Packaging &

• Materials
Equipment Labeling
GMP
• Is that part of quality assurance aimed
at ensuring that products are
consistently manufactured to a quality
appropriate to their intended use.
 Quality Control
• Is that part of GMP concerned with sampling,
specification and testing, documentation and
release procedures which ensure that the
necessary and relevant tests are performed and
the product is released for use only after
ascertaining it’s quality.
Quality control responsibilities:

TESTING OF BULK TESTING OF FINISHED STABILITYY PROGRAM REVIEW BATCH RELEASE PRODUCT,
COMPONENETS PRIOR PRODUCT PRIOR TO RECORDS, LABELS QC TEST RESULTS
TO USE BY RELEASE FOR SALE
PRODUCTION

TRAINING, AUDITING CUSTOMER

COMPLAINTS
 Quality assurance
• It is the sum of total of the organized
arrangements with the objective of
ensuring that products will be of the
quality required for their intended use.
Functions:

Adequates are made Process validation in

Adequate control on
for manufacturing,
starting material, accordance with
supply and the use of
intermediate and bulk established
correct starting and
products procedures
packing material
 • QC is that part of GMP • QA is the sum total of
QC & QA which is concerned with organized arrangements
sampling, specifications, made with the object of
testing and with in the ensuring that product
organization, will be of the quality
documentation and required by their
release procedures intended use.
which ensure that the
necessary and relevant
tests are carried out.
 • QA is all those planned
• QC is operational
or systematic actions
laboratory techniques necessary to provide
and activities used to adequate confidence
fulfill the requirement that a product will
of quality. satisfy the requirements
• QC is lab based. for quality.
• QA is company based.
 cGMP • pharmaceutical stability studies are an essential
component of the development and lifecycle of
Pharmaceutical pharmaceutical products, in particular,
supporting the development process and IND /
Stability NDA submission activities. They allow
Studies and evaluation of active pharmaceutical ingredient
(API) stability or drug product stability under
ICH Storage the influence of a variety of environmental
factors such as temperature, humidity and light.
 • analytical laboratory network provides
development and validation of stability-
Stability indicating methods utilizing a range of
technologies to identify and quantify
Testing and degradation products. Routine time point
testing includes the usual tests such as assay
Analysis and impurity analysis, dissolution, moisture,
hardness, friability and disintegration.
   EQUIPMENT

Equipment used in the

manufacture, processing, packing, The layout and design of
or holding of a drug product shall equipment must aim to avoid
be of proper design, sufficient cross-contamination, build-up of
size, and suitably located to dust or dirt and in general any
facilitate operations for its reverse effect on the quality of
intended use and its cleaning and products.
maintenance.
The properties of the materials of construction of the equipment are
concerned, 
there are two major concerns:

• The possibility of contamination, or degradation, of

the product by the material from which the
equipment is constructed.
  
• The action of the product, or material in-process, on
the material from which the equipment is
constructed.
ALL SERVICE PIPINGS PRODUCTION LABORATORY NON-DEDICATED CURRENT DRAWINGS
AND DEVICES EQUIPMENT SHOULD EQUIPMENT AND EQUIPMENT SHOULD OF CRITICAL
SHOULD BE BE THOROUGHLY INSTRUMENTS BE CLEANED EQUIPMENT AND
PROPERLY MARKED CLEANED ON A SHOULD BE SUITED ACCORDING TO SUPPORT SYSTEMS
AND SPECIAL SCHEDULED BASIS. TO THE TESTING VALIDATED CLEANIN SHOULD BE 
ATTENTION PAID TO PROCEDURES G PROCEDURES MAINTAINED.
THE PROVISION OF UNDERTAKEN. BETWEEN
NON- PRODUCTION OF
INTERCHANGEABLE DIFFERENT
CONNECTIONS  OR PHARMACEUTICAL P
ADAPTORS FOR RODUCTS TO
DANGEROUS GASES PREVENT CROSS-
AND LIQUIDS.  CONTAMINATION. 
   Materials

Intermediate and
General Starting materials Packaging materials
bulk products

Rejected, recovered,
Finished products reprocessed and Recalled products Returned goods
reworked materials

Reagents and
Reference standards Waste materials
culture media
 The main objective of a pharmaceutical plant is to produce
finished products for patients’ use from a combination of materials
(starting and packaging). 

Materials include starting materials, packaging materials, gases,

solvents, process aids, reagents and labelling materials. 

General: No materials used for operations such as cleaning, lubrication

of equipment and pest control, should come into direct contact
with the product. Where possible, such materials should be of a
suitable grade (e.g. food grade) to minimize health risks. 

All incoming materials and finished products should be

quarantined  immediately after receipt or processing, until they
are released for use or distribution.
Starting Materials
 The purchase of starting materials is an important
operation that should involve staff who have a particular
and thorough knowledge of the products and suppliers. 

 If one delivery of material is made up of different batches,

each batch must be considered as separate for sampling,
testing and release. 
Packaging Materials
 The purchase, handling and control of primary and printed
packaging materials should be as for starting materials. 

 All products and packaging materials to be used should be

checked on delivery to the packaging department for
quantity, identity and conformity with the packaging
instructions. 
 Intermediate and Bulk
Products
Intermediate and bulk products should be
kept under appropriate conditions.
Intermediate and bulk products purchased
as such should be handled on receipt as
though they were starting materials.
Finished Products

    Finished products should be

held in quarantine until their
final release, after which they
should be stored as usable stock
under conditions established by
the manufacturer. 
Reference Standards

 Whenever official reference standards exist, these

should preferably be used. 
 Reference standards prepared by the producer
should be tested, released and stored in the same
way as official standards. 
Waste Provision should be made for the proper and safe
Materials storage of waste materials awaiting disposal. Toxic
substances and flammable materials should be stored
in suitably designed, separate, enclosed cupboards.

Waste material should not be allowed to accumulate.

It should be collected in suitable receptacles for
removal to collection points outside the buildings.
 Processing Operations
Before any processing operation is started, steps should be taken to ensure that the
work area and equipment are clean and free from any starting materials, products,
product residues, labels or documents not required for the current operation.

Pipes used for conveying distilled or deionized water and, where appropriate, other
water pipes should be sanitized and stored.

Measuring, weighing, recording, and control equipment and instruments should be

serviced and calibrated at prespecified intervals and records maintained.
PACKAGING OPERATIONS
 When the programme for packaging operations is being set up,
particular attention should be given to minimizing the risk of
cross contamination, mix-ups or substitutions. 
 Products that have been involved in an unusual event during
packaging should be reintroduced into the process only after
special inspection, investigation by staff.
 Any divergence or failure of a batch to meet production
specifications should be thoroughly investigated.A written
record of the investigation should be made and should include
the conclusion and follow up action.
API Manufacturing Process
API
Secondary Manufacturing Dosage Forms
Secondary Manufacturing Process - Tablets
SMP – Sterile Parenteral for Injection
Biotechnology Manufacturing Process

API
COMPONENTS OF
GMP
• GMP requires that the manufacturing process is fully defined before being initiated and
all the necessary facilities are provided. In practice, personnel must be adequately
trained, suitable premises and equipment used, correct materials used, approved
procedures adopted, suitable storage and transport facilities available, and appropriate
records made. The manufacturing premises of good design and regularly monitored is
the most important component. There should be quality control of finished product, raw
materials and packaging materials. The equipment of good design is to be considered
and all the equipments are required to be maintained properly. There should be a correct
choice of cleaning equipment. The staffs should be trained well and should be wearing
protective clothing while on work. There should be written procedures for carrying out
the operations.
• REFERENCES Good
Manufacturing Practices (GMP)
for Medicinal Products Jaya Bir
Karmacharya Omnica
Laboratories Private Limited
Nepal PAGE 105-108
 Good manufacturing
practices for
pharmaceutical products
• GMP is that part of QA which ensures that products are
consistently produced and controlled to the quality
standards appropriate to their intended use and as
required by the marketing authorization. GMP are
aimed primarily at diminishing the risks inherent in any
pharmaceutical production. Such risks are essentially
of two types: cross-contamination (in particular of
unexpected contaminants) and mix ups (confusion)
caused by, for example, false labels being put on
containers.
Under GMP:

(a) all manufacturing processes are clearly defi ned, systematically (b) qualifi cation and validation are performed
reviewed in the light of experience, and shown to be capable of
consistently manufacturing pharmaceutical products of the required
quality that comply with their specifi cations;
(c) all necessary resources are provided,
including:
(i) appropriately qualifi ed (ii) sufficent premises and (iii) suitable equipment
and trained personnel; space and services;

(iv) appropriate materials, (v) approved procedures (vi) suitable storage and
containers and labels; and instructions; transport;

(vii) adequate personnel,

laboratories and
equipment for in-process
controls;
(d) instructions and procedures are written in
(e) operators are trained to carry out procedures
clear and unambiguous language, specifi cally
correctly;
applicable to the facilities provided;

(f) records are made (manually and/or by

recording instruments) during manufacture to
(g) records covering manufacture and
show that all the steps required by the defi ned
distribution, which enable the complete history
procedures and instructions have in fact been
of a batch to be traced, are retained in a
taken and that the quantity and quality of the
comprehensible and accessible form
product are as expected; any signifi cant
deviations are fully recorded and investigated;
(h) the proper storage and distribution of the products minimizes any
risk to their quality;

(i) a system is available to recall any batch of product from sale or (j) complaints about marketed products are examined, the causes of
supply quality defects investigated, and appropriate measures taken in
respect of the defective products to prevent recurrence.
Pharmaceutical Regulatory
Agencies and Organizations
Around the World
• As the pharmaceutical industries throughout
the world are moving ahead towards becoming
more and more competitive, regulatory
agencies are being established in various
countries across the globe. Regulatory agencies
and organizations play a vital role to meet the
requirements of legal procedures related to
drug development process in a country. Every
country has its own regulatory authority, which
is responsible to enforce the rules and
regulations and issue the guidelines to regulate
drug development process,licensing,
registration, manufacturing, marketing and
labeling of pharmaceutical products.
MHRA – Medicines and TGA – Therapeutic
EMA – European FDA – US Food and Drug
Healthcare products Health Canada (Canada) Goods Administration
Medicines Agency (EU) Administration (USA)
Regulatory Agency (UK) (Australia)

Turkey - Republic of
Japanase PMDA – Chinese Authorities -
MPA – Medicinal Turkey Ministry of
Pharmaceutical and State Food and Drug
Products Agency Health Turkish
Medical Devices Agency Administration, P.R.
(Sweden) Medicines and Medical
(Japan) (China)
Devices Agency
 INTERNATIONAL REGULATORY
AGENCIES AND ORGANIZATION

WORLD HEALTH PAN AMERICAN WORLD TRADE INTERNATIONAL

ORGANIZATION (WHO) HEALTH ORGANIZATION (WTO) CONFERENCE ON
ORGANIZATION (PAHO) HARMONIZATION (ICH)
• are some of the international regulatory
agencies and organizations which  also play
essential role inall aspects of pharmaceutical
regulations  related to drug product
registration, manufacturing, distribution, price
control, marketing, research and development,
and intellectual property protection. The major
challenges of these regulatory agencies and
organizations around the worldare to ensure
the safety, quality and efficacy of medicines and
medical devices, harmonization of legal
procedures related to drug development,
monitoring and ensuring compliance with
statutory obligations.
 Chemical engineering
within the
pharmaceutical industry
• The pharmaceutical industry is heavily
regulated by regulatory bodies such as the FDA
and MHRA. With such heavy regulation there is
a need for engineers who can ensure the
processes on site adhere to applicable
regulations including GMP. This needs to be
done on both a manufacturing level and at
laboratory stages such as R&D and QC testing.
• With such a wide range of chemical processes
and manufacturing equipment used it is no
wonder that chemical engineers play an
important role in the development and
manufacture of pharmaceutical products. There
are a number of departments that benefit from
the skills a chemical engineer can bring to a
team including applicable transferable skills
when working with production and packaging
equipment. If a plant based role is not
something you are interested in there are a
number of laboratory and office based roles
within the scientific industry that would be
suitable.
Chemical engineers can work in a wide range of roles including:

PROCESS ENGINEERING / PRODUCT DEVELOPMENT RESEARCH AND TESTING/ QUALITY MANUFACTURING/PRODUC

PLANT ENGINEERING (DEVICE) DEVELOPMENT CONTROL TION ENGINEERING

QUALITY / VALIDATION PROJECT MANAGEMENT DESIGN ENGINEERING

ENGINEERING
• The pharmaceutical industry is seen as a safe
bet during unstable markets due to the need for
new medicines being essential. With this in
mind it has never been a better time to take a
role within the pharmaceutical sector. As the
pharmaceutical industry is heavily regulated,
engineers with experience working in the sector
have a large number of transferable skills for
less regulated sectors such as parts of the
chemical industry.
 Question :
what is the relation between chemical
engineering and pharmaceutical?
• Fabrication.
And reactions of medicine mostly
done in reactors which is chemical
engineering.
R&D is chemists and pharma work
but applying it to the production
scale is chemical
engineering.Process control is
pure chemical engineering.
Add to that chemical engineers
can do the chemists work.
• -Pharmaceutical require GMP
(Good Manufacturing Process)
based on chemical engineering
unit operation.
Pharmaceutical require basic
and fundamental formulation
and analysis while chemical
engineering determine cost
effective process based on
feasibility study.
Chemical Engineering is used for
the mass production of
pharmaceutical products or life
saving products.