2. CGMP
CGMP refers to the Current Good
Manufacturing Practice regulations
enforced by the US Food and Drug
Administration (FDA). CGMPs provide
for systems that assure proper design,
monitoring, and control of
manufacturing processes and facilities.
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4. IMPORTANCE
Ensure that the
product are safe for
human dose.
Prevent the toxicity .
Side effect due to
variation in drug
content.
Prevent or control
contamination.
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5. PRINCIPLES
1. Design and construct the facilities and
equipment properly.
2. Follow written procedure and instruction.
3. Documentation work.
4. Validation work.
5. Check the facilities and equipment.
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6. 6. Write step by step operating procedure and work on
in sanitation.
7.Design , demonstrate, develop job competence.
8.Protect against contamination
9.Control component and product related to process.
10.Conduct planned and periodic audit.
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7. OBJECTIVE
• To understand where the regulation come from, who has
enforcement authority, and why you need to comply.
• To understand the fundamental benefits, key part of GMP.
• To minimize the risk involved in pharmaceutical production
that can’t eliminated by testing the final product.
• Poor chance for the patient to detect anything wrong.
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8. GUIDELINES
AREA TO BE
COVERED
• GENERAL CONSIDERATION
• PERSONNEL
• PREMISES
• EQUIPMENT
• SANITATION
• STANDERED OPERATING PROCEDURE
• RAW MATERIAL
• SELF INSPECTION AND AUDIT
• MASTER FORMUIA RECORD
• BATCH RECORD
• WARE HOUSING AREA
• REFERANCE SAMPLE
• VALIDATION AND PROCESS VALIDATION
• LABELS AND OTHER PRINTED MATERIALS
• QA
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10. LOCATION AND SURROUNDING
Building for the
manufacturing situated
such that should be avoid
the risk of contamination
Premise used for
manufacturing of drug
should be designed to
ensure good sanitation
Premise should be
carefully maintain
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11. BUILDING AND FECILITIES
Buildings used for
manufacturing should be
constructed ,adapted ,
maintain to suit the
manufacturing operation
under hygienic condition
Avoid possibility of contamination and
cross contamination by providing
suitable mechanism
Avoid the risk of mix up of
different category of drugs or
with the raw materials
Premise should be constructed ,
equipped to provide maximum
protection against insects and
other animals
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14. WAREHOUSING AREA
• Adequate area shall be designed to allow sufficient &orderly
warehousing of various categories of materials &product.
• To ensure good storage condition they shall be dry, clean
with acceptable temperature limit.
• There shall be separate sampling area for active raw materials
and excipient.
• Printed, packaging materials shall be stored in safe , separate
area.
• Regular checks shall be made to ensure adequate steps are
taken against spillage , breakage, leakage etc.
• Pest control should be done regularly. 14
16. WATER SYSTEM
There should be
validated system for
the treatment of
water drown from
own or other source
to render it potable
in accordance with
standards .
Purified water s
used for all the
operation except
washing and
cleaning operation
potable water may
be used
Water shall be
stored in tank.
It should be
free from
microbial
growth.
Tank shall be
cleaned
periodically and
record should be
maintained by
licensee in its
behalf
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17. DISPOSAL OF WASTE
Disposal of sewage and
effluent shall be in
conformity with the
requirement of
Environment Pollution
control Board.
All biomedical
waste shall be
destroyed as per
Biomedical waste
Rule 1996
Record should
be maintained
for all disposal
waste.
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18. PRODUCTION AREA
• The production area shall be designed to allow the production
preferably in uniform - flow & with logical sequence of operation.
• To avoid cross contamination separate dedicated , self contained
requirements made available for product like penicillin.
• Working and in- process space shall be adequate to permit logical
positioning of equipment, material, movement of personnel to avoid
cross contamination& minimize the risk of wrong application of any
manufacturing &controlling measures.
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19. ANCILIARY AREA
• Rest &refreshment area shall be separate from each other . These area shall
not be lead directly to manufacturing &storage area.
• Facilities for storing, changing cloth & washing are easily accessible &
adequate for number of users.
• Toilet for males &females are separates & not directly connected to
production , storage area.
• Tool & spare parts for use in sterile area shall be disinfectant before carried
into the production area.
• Animal housing shall be isolated from other area.
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20. QUALITY CONTROL AREA
• It is independent of production area. Separate area shall be provided for
each physic- chemical , biological, micro biological , radio isotope analysis.
• Separate instrument room with adequate area shall be provided for sensitive
instruments employed for analysis.
• Adequate space shall be provided to avoid mix-up & cross contamination.
Sufficient storage space provided for test sample, retained sample, reference
standards , records.
• The laboratory is provided with regular supply of water of appropriate
quality for cleaning and testing purpose.
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21. SANITATION IN THE PREMISES
• The manufacturing area should not be used for any other purpose.
• The manufacturing premises shall be maintained in an orderly manner ,
free from accumulation of dust.
• Eating , drinking , smoking not permitted in the manufacturing area.
• Manufacturing area should not be used for storage of materials except
materials being processed.
• A routine sanitation programme shall be drawn up &observed which be
properly record
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22. EQUIPMENT
• All manufacturing equipment not in use must be stored in a manner
to keep it clean and good working condition.
• All equipment must have an accurate well documented log showing
what produced in it.
• All equipment must have an cleaning log showing when . How ,
whom each part of the equipment was cleaned.
• All equipment must have an identification number which appear in
the batch record.
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23. Equipment used for manufacturing of drug shall constructed, designed
&maintained to
• Achieve operational efficiency to attain desire quality.
• Prevent physic , chemical change through surface contact.
• Prevent contact of any substance required for operation of equipment
like lubricant.
1. The accuracy of the equipment used for specific filling shall be checked
& conformed at regular intervals and record such check shall be
maintained.
2. The parts of the production equipment come in contact with the
product shall not be reactive to an extend that would affect the quality of
the product.
3. To avoid accidental contamination non toxic grade of lubricant are used.
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24. • Equipment used exclusively by a product
,individual log is not required.
• All equipment must be sanitised after the
cleaning
• All equipment must be validated.
• Equipment should not be used as storage of
things that does not belong to them.
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27. PERSONNEL
The manufacture should have an
adequate number of personal with
necessary qualification.
The personal for quality assurance
and quality control shall be suitably
qualified and experienced.
Written duties of technical and
quality control personnel shall be
laid and followed strictly.
Training improves human
performance on job.
Smoking, drinking, chewing are
prohibited in the area of production
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29. SANITATION OF WORKERS
• All the personnel wear
clean body covering,
appropriate their work.
• Smoking , eating , drinking
are not permitted in area
of production , storage.
• Direct contact shall be
avoid between the hands&
raw materials , products
• Avoid talking, use mask .
• Don’t touch the body parts
while handling the product.
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30. DOCUMENTATION & RECORDS
• Its aim is to define specification for all material, method of manufacture& control
etc , To ensure that all the personnel concerned with manufacture know the
information necessary to decide whether or not to release a batch of drug for
sale. And to provide an audit trail that shall permit investigation of the history of
any suspected defective batch
Documents designed, prepared, reviewed &controlled shall comply with these rule.
1. Document approved , signed, dated by appropriate and authorised person.
2. Document shall specify the title, nature, purpose.
3. It should be regularly reviewed and kept up to date.
4. If any alteration made in the document shall be signed and dated.
5. The record shall be completed at the time of each operation in such away that
all significant activities concerning the manufacturing of pharmaceutical product
are traceable. 30
31. MASTER FORMULA RECORD
• There shall be master formula record relating to manufacturing procedure for each
product and batch size to be manufactured. It is prepared by competent medical
staff.
It include:-
• The name of the product together with product reference code relating to its
specification.
• The patent or proprietary name of the product along with generic name ,description
of the dosage , strength, batch size.
• Name , quality , reference material, all starting material used.
• A statement of excepted final yield of the product.
• Detailed step wise processing instruction and the time taken for each step.
• Any special precaution to observed and packing details
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32. BATCH MANUFACTURING RECORD
• The licensee shall maintain BFR as per schedule U for each
batch of drug produced.
• It provide complete manufacturing history of each batch of
drug. Showing that it is manufactured , tested, as per
manufacturing procedure and master formula.
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33. DISTRIBUTION RECORD
• Record for the distribution maintain in a manner such that finished
batch of a drug can be traced to retain level to facilitate prompt and
complete recall of the batch if necessary.
• Periodic audit of warehousing practices followed at distribution
centre shall be carried out and record shall maintain .
• Detailed instruction for ware housing and stocking of large volume
parenteral ,if stocked shall be complied with after the batch is
released for distribution
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34. REFERENCES
1.Novel Drug Delivery System and Regulatory affaires by Dr.
Yajmansudhaker& Jayaveera page no :355-367.
2.Pharmaceutical jurisprudence and Ethics (forensic pharmacy)
by Dr.S.P.Agarwal page no:63-79.
3.Industrial pharmacy by Dr . Shyamala Bhaskaran pageno 259-
266.
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