GOOD

MANUFACTURING
PRACTICES
DEPARTMENT OF
ARPITA JENA ASSISTANT PROFESSOR
PHARMACEUTICAL ANALYSIS
DEFINITION OF GMP

BY WHO: “GMP is that part of Quality Assurance, which ensures that products are consistently
produced and controlled to the quality standards appropriate for their intended use and the legal
requirements. GMP is thus concerned with both production and Quality control parameters”.

CONCEPT OF GMP

 GMP guidelines represent minimal standards that are necessary conditions for marketing
authorization, drugs are considered to be adulterated, if GMP’s are not met.

 It comprises strong recommendations on quality management, personnel, production

facilities and equipment's, documentation and records, production and in-process controls,
packaging and labelling, storage and distribution, laboratory controls, validation, complaints
and recalls.

 It helps in implementing modern quality systems and risk management approaches to meet
the requirements of quality products to ensure their intended use.

 It ensures that quality is build into the organization and the processes and operations in the
manufacture of the products should be carried out strictly.

 The guideline serves as a basic minimum requirement for both local and foreign
pharmaceutical companies to be authorized for import products. It is also a reference and
guidance tool to the Authority for GMP inspection and licensing of establishments.

GMP REQUIREMENTS

 All manufacturing processes are clearly defined, systematically reviewed and should be
capable of consistently manufacturing medicinal products of the required quality and
complying with their specifications and/or marketing authorization.

 Critical steps of manufacturing processes and significant changes to the process are
validated.

 All necessary facilities for GMP are provided including.

 1. Appropriately qualified and trained personnel.

 2. Adequate premises and space.

 3. Suitable equipment and services.

 4. Correct materials, containers and labels.

 5. Approved procedures and instructions.

 6. Instructions and procedures are written in an instructional form in clear and unambiguous
language, specifically applicable to the facilities provided.

 7.Operators are trained to carry out procedures correctly.

 8. Records are made, manually and/or by recording instruments, during manufacture. Any
significant deviations are fully recorded and investigated.

 9. Records of manufacture including distribution which enable the complete history of a

batch to be traced are retained in a comprehensible and accessible form.

 10. The distribution of the products minimizes any risk to their quality.

 11. A system is available to recall any batch of product, from sale or supply.

 12. Complaints about marketed products are examined, the causes of quality defects
investigated and appropriate measures taken in respect of the defective products and to
prevent re-occurrence.
PERSONNEL  There must be sufficient
qualified personnel to
carry out all the tasks
which are the
responsibility of the
manufacturer.
 Individual responsibilities
should be clearly
understood by the
individuals and recorded.
 All personnel should be
aware of the principles of
GMP that affect them
and receive training,
including hygiene
instructions.
 The manufacturer should
have an adequate
number of personnel
with the necessary
qualifications and
practical experience. The
responsibilities placed on
any one individual should
not be so extensive as to
present any risk to
quality.
 The manufacturer must
have an organization
chart. People in
responsible positions
should have specific
duties recorded in
written job descriptions
and adequate authority
to carry out their
responsibilities. There
should be no gaps or
unexplained overlaps in
the responsibilities of
those personnel
concerned with the
application of GMP.
 Key Personnel includes
the head of production,
the head of Quality
Control, and the head of
engineering and if at least
one of this person is not
responsible for the
release of products the
 authorized person(s)
designated for the
purpose (Quality
Assurance Head).
 The heads of production
and Quality Control must
be independent from
each other.

BUILDING AND FACILITIES

 Buildings should be of
suitable size, construction
location to facilitate
cleaning, maintenance,
and proper operations.
 Space should be
adequate for the orderly
place of equipment and
materials to prevent mix-
ups.
 The movement of
components and product
through the building
must be designed to
prevent contamination.
 Operations should be
performed within
specifically defined areas
having adequate control
systems and to prevent
contamination or mix-
ups.
 Holding rejected
materials and storage of
in-process materials
released components,
drug product containers,
closures and labelling.
 Manufacturing and
processing operations.
 Packaging and labelling
operations.
 Quarantine storage
before release of drug
products.
 Storage of drug products
after release.
 Aseptic processing
 Floors, walls, and ceilings
of smooth, hard surfaces
that is easily cleanable.
  Temperature and
humidity control.
 An air supply filtered
through High Efficiency
Particulate air (HEPA)
filters under positive
pressure regardless of
whether flow, laminar or
non-laminar.
 A system for monitoring
environmental
conditions, a system for
cleaning and disinfecting
the room and equipment
to produce aseptic
conditions.
 A system for maintaining
any equipment used to
control the aseptic
conditions.
 Heating, ventilation, and
air conditioning (HVAC).
 Adequate ventilation is
required in all areas.
 Sewage, trash, and other
refuse in and from the
building and immediate
premises must be
disposed of in a safe and
sanitary manner.

EQUIPMENTS
 Equipment’s should be of
appropriate design,
adequate size, and
suitably located to
facilitate operations for
its intended use and for
cleaning and
maintenance.
 Equipment’s, should be
constructed so that
surfaces that contact
components, in-process
materials, or drug
products should not be
reactive.
 Any substance required
for operation such as
lubricants or coolants
shall not come into
 contact with drug
products, containers and
so on.
 Equipment and utensils
should be cleaned,
maintained, and sanitized
at appropriate intervals
to prevent malfunctions
or contamination that
would alter the drug
product beyond the
official requirements.
 Written procedures must
be established and
followed for cleaning and
maintenance of
equipment and utensils
used in the processing of
a drug product.

SANITATION AND HYGIENE

 A high level of sanitation
and hygiene should be
practiced in every aspect
of the manufacture of
pharmaceutical products.
 Sanitation and hygiene
covers personnel,
premises, equipment and
apparatus, production
materials and containers,
products for cleaning and
disinfection, and anything
that could become a
source of contamination
to the product.
 Potential sources of
contamination should be
eliminated through an
integrated
comprehensive program
of sanitation and hygiene.
 The layout and design of
premises must aim to
minimize the risk of
errors and permit
effective cleaning and
maintenance in order to
avoid cross-
contamination and
facilitate cleaning.
  A high level of personal
hygiene should be
followed and observed by
all those concerned with
manufacturing processes.
In particular, personnel
should be instructed to
wash their hands before
entering production
areas. Signs to this effect
should be posted and
instructions observed.

CONTROL OF COMPONENTS, DRUG PRODUCTS CONTAINERS AND

CLOSURES  1. General requirements.
 2. Receipt & storage of
untested components,
drug product containers
and closures.
 3. Testing and approval or
rejection of components,
drug product containers
and closures.
 4. Use of approved
components, drug
product containers, and
closures.
 5. Retesting of approved
components, drug
product containers, and
closures.
 6. Rejected components,
drug product containers,
and closures.
 7. Drug product
containers and closures.
 All containers and
closures intended for use
shall comply with the
pharmacopeial
requirements. Suitable
validated test methods,
sample sizes,
specifications, cleaning
procedure and
sterilization procedure,
wherever indicated, shall
be strictly followed to
ensure that these are not
reactive, additive,
absorptive, or leach to an
 extent that significantly
affects the quality or
purity of the drug.
 No second hand or used
containers and closures
shall be used.

PRODUCTION AND PROCESS CONTROLS

 Written procedures for
production and process
control must be written
and followed. These
procedures should be
designed to assure that
the drug products have
the identity, strength,
quality and purity they
are represented to
possess.
 All actions must be
documented at the time
of performance. Any
deviations from the
written procedures must
be recorded and justified.
 The batch must be
formulated with the
intent to provide not less
than 100% of the labeled
amount of active
ingredient.
 Weighing, measuring, or
subdividing operations
for all components must
be adequately
supervised.
 Actual yield and
percentage of theoretical
yield should be
determined at the
completion of each
appropriate phase of
manufacturing,
processing, packaging or
holding.
PACKAGING AND LABELING CONTROLS
 Materials examination
and usage criteria.
 Labeling issuance.
 Packaging and labeling
operations.
 Tamper-evident
packaging requirements
for over-the-counter
(OTC) human drug
products.
 Drug product inspection.
 Expiration dating.

HOLDING AND DISTRIBUTION

 Warehousing procedures.
 Distribution procedures.
 Prior to distribution or
dispatch of given batch of
a drug, it shall be ensured
that the batch has been
duly tested, approved
and released by the
quality control personnel.
Pre-dispatch inspection
shall be performed on
each consignment on a
random basis to ensure
that only the correct
goods are dispatched.
 Detailed instructions for
warehousing and stocking
of Large Volume
Parenteral, if stocked,
shall be in existence and
shall be complied with
after the batch is
released for distribution.
Periodic audits of
warehousing practices
followed at distribution
centres shall be carried
out and records thereof
shall be maintained.
Standard Operating
Procedures shall be
developed for
warehousing of products.

LABORATORY CONTROLS
 General requirements
 Testing and release for
distribution
 Stability testing
 Special testing
requirements
 Reserve samples
 Animals used in testing
components

RETURNED AND SALVAGED DRUG PRODUTCS

 1. Returned drug
products
 2. Drug product salvaging
• Adequate areas shall be
designed to allow
sufficient and orderly
warehousing of returned
or recalled products.
• Segregation shall be
provided for the storage
of rejected, recalled or
returned materials or
products.
 REPORTS AND RECORDS (DOCUMENTATION)
 1. General requirements
 2. Equipment cleaning
and use log
 3. Component, drug
product container,
closure, and labelling
records
 4. Master production and
control records
 5. Batch production and
control records
 6. Production record
review
 7. Laboratory records
 8. Distribution records
 9. Complaint files

THANK YOU
Mrs. ARPITA JENA
ASSISTANT PROFESSOR, DEPARTMENT OF PHARMACEUTICAL ANALYSIS
Pharmaq07@gmail.com