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2 DEFINATION OF GMP
2 PRINCIPLES OF GMP
2 IMPORTANCE OF GMP
2 INTERRELATIONSHIPS OF QA,QC,GMP
2 IMPORTANT DOCUMENTS IN GMP
2 ATTRIBUTES OF GOOD DOCUMENTS
2 GENERAL PROVISIONS
1.BUILDING&FACILITIES
2.EQUIPMENTS
Quality
Safety Efficacy
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Is that part of GMP concerned with
sampling, specification & testing,
documentation & release
procedures which ensure that the
necessary & relevant tests are
performed & the product is
released for use only after
ascertaining itǯs quality
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À d GMPs dit c tis c a?
2. Definitions
1. Warehousing procedures.
2. Distribution procedures.
1. General requirements.
2. Testing and release for distribution.
`. Stability testing.
4. Special testing requirements.
5. Reserve samples.
6. Laboratory animals.
7. Penicillin contamination.
1. General requirements.
2. Equipment cleaning and use log.
`. Component, drug product container, closure, and
labeling 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.
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