CURRENT GOOD MANUFACTURING
PRACTICES AS PER WHO
M.PHARMACY 2nd SEMISTER
DEPARTMENT OF PHARMACEUTICS
TRINITY COLLEGE OF PHARMACEUTICAL SCIENCES
Activities of cGMP
Surroundings ,Building and Facilities
Manufacturing operation control
Sterile Pharmaceutical products
Site plant security
Documentation and records
• cGMP is defined as “it is a 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”
• cGMP is thus concerned with both production and quality control matters.
• cGMP provides complete guidelines on designing material and product
specifications, testing methods and reproducing methods for same.
• The drug regulatory authorities all over world e.g. WHO,
M.H.RA.(U.K),T.G.A(Australia),M.C.C(South Africa),U.S.F.D.A etc. Provides
guidelines based on their requirements.
ACTIVITIES OF cGMP
• cGMP expects that all the people should be trained.
• It provides complete guidelines on requirements of facilities
• cGMP talks about how you should control the quality of
materials at every stage.
• It also further talks about quality , production systems and
• The manufacturer should have an adequate number of personal with the
necessary qualification and practical experience.
• Academic qualification required in various areas of specialization
▫ Production: B.Pharm ; M.Pharm; Ph.D.
▫ Q.C/Q.A: B.Pharm ; M.Pharm , M.S.C
P.G. in material management
▫ Finance :M.com, M.B.A, Chartered accountants
• People in an origination are the main resource and as more value and
importance than other resources like facilities ,equipment and materials.
• A trained person generally has the knowledge, skill and attitude relevant to
their job and that too in the appropriate levels.
• Training improves human performance on job, working capacity.
• Smoking ,drinking, chewing, food drinking material should not be
permitted into manufacturing, production areas
SURROUNDINGS,BUILDING AND FACILITIES
• Premises must be located, designed, constructed, adapted ,maintained to suit the
operation to be carried out.
• Premise should be designed and equipment maximum protection against the entry
of insects or other animals
• Washing and toilet facilities should be provided for each individuals in working
areas, cupboards must be provided in change rooms for keeping cloths, other
• Rest and refreshment rooms should be separate from other areas, animal
houses should be well-isolated from other areas, with separate entrance .
• Storage area should sufficient capacity to allow orderly storage of the various
types of materials and products,
• Temperature and humidity conditions should be maintained in storage areas,
• Production area adequate space to prevent cross contamination, area should be
effectively ventilated with air control facilities.
Equipment design, size, and location.
Equipment cleaning and maintenance.
Balances and other measuring equipment
shall be calibrated and checked
on periodical basis in accordance
with the SOP’s and records
• Stored properly and records maintained as per schedule U .
• All incoming raw material shall be quarantined immediately after receipt or
• Stored in such a manner that FIRST IN FIRST OUT principle.
• Purchased from approved sources under valid purchase voucher stored
appropriately with labels.
• Authorized staff shall be appointed by license in raw material department
he/she may be from QC department.
• If any product failed established specification or other relevant qualities
should be rejected
• Reagents made up in the laboratory should be prepared according to
written procedure and appropriately labeled. the label should indicate the
concentration, standardization factor, shelf life.
• The word “QUALITY” has its origin in a Latin word “Qualitas” means
• “quality should be built into the product, and testing alone cannot be relied
onto ensure product quality.”
• Each and every manufacturing unit should have its own QC laboratory
with qualified and experienced staff.
It is concerned with sampling, specification, testing, documentation and release
• S.O.P are maintained for each and every step in the process.
• Each specification for raw
materials, intermediates, final
product ,packing materials shall
be approved and maintained by
• Should be independent of the production areas and divided in to separate sections.
• And radio-isotope analysis
• Space shall be provided for
test samples, retained samples , reference standard.
• Suitable to construction materials and ventilation.
Manufacturing Operational Control
• The main objective of the manufacturing is to produce a quality
• Production operation should follow manufacturing and marketing
• Simultaneous operations should not performed in the same room to prevent
• Cleaning, sanitation and disinfection of manufacturing premises falls under
the category of achieving purity in the finished pharmaceutical by avoiding
• “It is the documented evidence which provide a high degree of assurance
that a specific process will consistently produce, a product meeting its pre -determined specifications and quality attributes” .
• Components of a production process such as facilities and equipment must
be validated before use.
• In pharmaceutical industry cleaning validation of facility , equipment and
apparatus is also considered.
• inspection of equipment for cleanliness immediately before use.
Sterile pharmaceutical products
• Sterile pharmaceutical products are very critical and sensitive products. these
products are free from living organisms , pyrogens and particulate matter.
• The production of sterile preparations should be carried out in clean area .
• The entry of personal and goods into sterile preparation rooms should be
through air lock systems.
• Only the minimum number of
Persons should be present in
Clean area .
Site and plant security
• Site and plant security is an essential part of the pharmaceutical
• This is mainly related to see that unauthorized persons are not entering in
the plant, which may results into adulteration of product.
DOCUMENTATION AND RECORDS
• A document is any written ,printed or computer generated information that
is going to provide some evidence. The method of making a document is
called as a documentation.
• It is part of QA and play an imp role in implementation of GMP.
• Documents shall specify the title ,nature and purpose and arranged in such
a manner that it should be easy to check.
• There should be a separate record
book shall be maintained for each
batch and should include
product name, batch no, size, etc.
• Inculcation of cGMP in the organization provides increased
quality of products with less wastage , more profit and
P.P Sharma, How to Practice GMPs., 3rd Edition.,2001,206-275.
FDA “Guidance for Industry: Q7A Good Manufacturing Practice
Guidance for Active Pharmaceutical Ingredients,” Section 19.
ICH Q7 Good Manufacturing Practice Guide For Active Pharmaceutical
Ingredients. Current step 4 version; November 2000 Website. Available
from: http://www.ich.org/LOB/media/MEDIA433.pdf [Last cited on 2010
Manohar A Potdar., cGMP for Pharmaceuticals., Pgno:1-259, 339-382.
FDA “Laboratory Inspection Guide.”
FDA “Inspection Guide for Bulk Drug Substances.”
Try not to become a man of success but
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