SRM college of pharmacy ,m.pharm 1st yr ...this slide describes about cgmp & this is reference for m.pharm students

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.