The document discusses the principles and practices of Current Good Manufacturing Practice (cGMP) as enforced by the US FDA, emphasizing quality assurance in the manufacturing of pharmaceutical products. It outlines essential components such as personnel qualifications, facility design, equipment maintenance, warehousing, standard operating procedures, and thorough documentation to ensure product quality and compliance with legal standards. cGMP aims to prevent contamination and mix-ups while ensuring that products meet specified quality criteria for their intended use.

1. PRESENTED BY
SOUMYA RANJANA SAHOO
DEPARTMENT OF
PHARMCEUTICS
SRM COLLEGE OF PHARMACY

2.  DEFINITION
 ACTIVITIES OF CGMP
 COMPONENTS OF CGMP
 PERSONNEL
 PREMISES
 EQUIPMENT
 WAREHOUSING AREA
 SANITATION
 SOP
 RAW MATERIALS
 PACKAGING & LABELLING CONTROL
 DOCUMENTATION AND RECORDS
 QA
 SELF AUDIT & INSPECTION
 CONCLUSION

3.  cGMP refers to the current good manufacturing
practise regulation enforced by the USFDA
 cGMP is defined as 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 provide for systems that assure proper
design,monitoring,control of manufacturing
process and facilities

4.  cGMP expects that all the people should be
trained
 It provides complete guidelines on
requirement of facilities
 cGMP provide information how you should
control the quality of materials at every stage
 It also further gives information about quality,
production system and their control

5.  GMP is a part of QA
 GMP main function is to produce quality product
consistently
 GMP must meet legal requirements of country
 GMP must meet both production and quality
control related issue
 WHO further comments that the main function
of GMP is to avoid mixups and contamination
risk

6.  Personnel should fulfil the minimum
qualification criteria.
 They should be properly trained.
 Sufficient number of experienced personnel
must be appointed.
 They must be completely free from
communicable diseases.
 If someone having skin diseases, open lesions,
allergic condition they shouldn’t allow to the
production area.

7.  Personal engaged in the manufacturing,
packing or holding of drug product should
wear clean clothes or gowns.
 Protective apparel like Head gear, face
mask, hand gloves, safety glass, foot covers
shall be worn to prevent drug product from
contamination.
 Personnel should have good sanitation and
health habits.
 Any person having any health problem
should undergo medical supervision.

10.  LOCATIONS
 DESIGN
 CONSTRUCTION

11.  Premises must be located in such a
geographical area that there is minimum risk
of contamination
 It should not located next to any other
industry or at the centre of the city
 There must be control in the pollution

12. It must be designed in such a way that
 It should have adequate space.
 Permit effective cleaning.
 Avoid cross contamination.
 It must have maximum protection against the entry of
insects, birds and animals.
 It must possess separate facility for other products such
as antibiotics, cytotoxic substances.
 Floor, Walls, Ceilings should be smooth and easy to
clean.
 Floors and walls must be coated with epoxyvinyl coating.

13.  Building used in manufacture , processing, packing, holding of
material should be of suitable size ,construction and location to
facilitate cleaning, maintenance.
 The orderly placement of equipments and materials to prevent
mix-ups between different components, drug product containers,
closures, in-process materials to prevent contamination.
 Adequate lighting should be provided in all area
 Air filter system including pre filter, HEPA filter must used and
there shall be adequate exhaust system.
 Portable water should be supplied under continuous positive
pressure
 There must be proper sewage system for disposal of the waste

14.  Adequate washing facility must provided including hot and
cold water, soap and detergents etc.
 HYGIENE AND MAINTAINANCE :
Eating,drinking,smoking should not be allowed in the
production area and the sanitization should be maintained
properly.

19.  Equipment should be designed, constructed,
maintained properly and should be made of
non reactive material such as High grade of
steel(316,302)
 Equipment should be
 Calibrated
 Accompanied by SOP
 Labelled
 Sterilized

23.  Warehousing area should be designed and adapted to ensure good
storage condition.
 Should be clean, dry ,maintained with acceptable temperature
limits.
 Should have appropriate house-keeping and rodents, pests and
vermin control.
 Separate sampling area for active raw material and excipients.
 Every material should be labelled and stored properly
 Fire prevention

30.  There should be written standard operating
procedure for each operations it includes
 For equipment
 For sampling
 For testing
 For process
 For packaging

31.  An inventory should maintained for raw material
to be used at any stage of manufacturing.
 Record should be maintain as per schedule
checked by qc department on receipt.
 It should be purchased from approved sources.
 It must be checked by qc department on
receipt.
 It should be labelled.

33. There should be a written procedures describing sufficient details
 Receipt
 Identification
 Storage
 Handling
 Sampling
 Testing of labelling and packaging material
 Any labelling or packaging material appropriate written
specification may be approved and released for use.
 Labels and other labelling material for each different drug
product,strength,dosage form or quantity of content shall be
stored separately with suitable identification.

34.  Prevention of mix-ups and cross
contamination by physical or spatial
separation from operation on other drug
products.
 Expiration dates should be appear on
labelling in accordance with the requirement
 Requirements for tamper-evident package
for packaging of OTC drug for retail shop

35.  A document is any written printed or computer
generated information that is going to provide some
evidence and the method of making document is called
as documentation.
 It is part of QA and play an important role in
implementation of cGMP
 Document shall specify the title, nature, purpose and
arranged in such a manner that it should be easy to
check.
 There should be separate record book shall be
maintained for each batch and should include product
name ,batch no, size etc.

36.  Batch production and control records shall be
printed for each batch
 Laboratory record shall include complete data
derived from all tests necessary to assure
compliance with established specification and
standard
 Distribution record shall contain the name strength
of the product and description of the dosage form,
name and address of the consignee, data and
quantity shipped etc

37.  The main objective of the quality assurance is to ensure
the products are of the quality required for their intended
use.
FUNCTIONS
 Adequate are made for manufacturing, supply and the
use of correct starting and packaging materials.
 Adequate control on starting material, intermediate and
bulk products.
 Process validation in accordance with established
procedure.

38. o Regular independent inspection is necessary to
evaluate the manufacture’s compliance with GMP in all
aspects of manufacturing
o Procedure for self inspection shall be documented
indicating
EVALUATION
CONCLUSION
RECOMENDAION FOR CORRECTIVE ACTION
o There should be BMR & MFR

39.  GMP compliance is not an option.
 Quality should be built into product.
 GMP covers all aspect of manufacturing activities prior
to supply.
 The role and involvement of senior management is
crucial.