Inspection and Auditing
Inspection - Answer-To control and enforce compliance with general GMP practices
Inspection - Answer-To authorize the manufacture of specific pharmaceutical products, normally in a
response to a licensing application
Pre-approval inspections
Inspection of pharmaceutical manufacturers
Inspection of drug distribution channels
Self-inspection - Answer-4 kinds of inspection
Pre-Approval Inspection (PAI) - Answer-Assures that a manufacturing site named in a drug application is
capable of manufacturing a drug product, and that the submitted data is accurate and complete.
Pre-Approval Inspection (PAI) - Answer-Objective of _________: Evaluation of establishment's
compliance with GMP requirements (environment, QM, personnel, facilities, equipment)
Pre-Approval Inspection (PAI) - Answer-Objective of _________: Evaluation of procedures and controls
implemented in pre-approval batches
Pre-Approval Inspection (PAI) - Answer-Objective of _________: Audit of completeness and accuracy of
the manufacturing and testing information and the process validation protocol
Pre-Approval Inspection (PAI) - Answer-Objective of _________: Collection of samples for validation and
verification of analytical methods
, NCEs (New Chemical Entities)
Drugs with narrow TI and drugs for serious conditions requiring an assured therapeutic response
Products associated with serious AEs, complaints, recalls
Products that are difficult to manufacture or test or products with doubtful stability
New applicants or manufacturers
Applications from manufacturers who have previously failed to comply with GMP - Answer-Priorities of
PAI
Misrepresentation of data or conditions relating to pre-approval batches
Pre-approval batches not manufactured in accordance with GMP
Inconsistencies and/or discrepancies raising significant questions concerning the validity of the records"
- Answer-Conditions where approval is withheld for PAI
Routine inspection, Concise inspection, Follow-up inspection, Special inspection, Quality systems review
- Answer-5 types of inspection for pharmaceutical manufacturers
Routine Inspection - Answer-Full inspection of all applicable components of GMP and licensing
provisions
Routine Inspection - Answer-Indicated when the manufacturer is newly established
Routine Inspection - Answer-Indicated when the manufacturer requests renewal of LTO
Routine Inspection - Answer-Indicated when the manufacturer has introduced new product lines or new
products, or has made significant modifications on existing product/s, or has made changes in key
personnel, product, or equipment
Inspection - Answer-To control and enforce compliance with general GMP practices
Inspection - Answer-To authorize the manufacture of specific pharmaceutical products, normally in a
response to a licensing application
Pre-approval inspections
Inspection of pharmaceutical manufacturers
Inspection of drug distribution channels
Self-inspection - Answer-4 kinds of inspection
Pre-Approval Inspection (PAI) - Answer-Assures that a manufacturing site named in a drug application is
capable of manufacturing a drug product, and that the submitted data is accurate and complete.
Pre-Approval Inspection (PAI) - Answer-Objective of _________: Evaluation of establishment's
compliance with GMP requirements (environment, QM, personnel, facilities, equipment)
Pre-Approval Inspection (PAI) - Answer-Objective of _________: Evaluation of procedures and controls
implemented in pre-approval batches
Pre-Approval Inspection (PAI) - Answer-Objective of _________: Audit of completeness and accuracy of
the manufacturing and testing information and the process validation protocol
Pre-Approval Inspection (PAI) - Answer-Objective of _________: Collection of samples for validation and
verification of analytical methods
, NCEs (New Chemical Entities)
Drugs with narrow TI and drugs for serious conditions requiring an assured therapeutic response
Products associated with serious AEs, complaints, recalls
Products that are difficult to manufacture or test or products with doubtful stability
New applicants or manufacturers
Applications from manufacturers who have previously failed to comply with GMP - Answer-Priorities of
PAI
Misrepresentation of data or conditions relating to pre-approval batches
Pre-approval batches not manufactured in accordance with GMP
Inconsistencies and/or discrepancies raising significant questions concerning the validity of the records"
- Answer-Conditions where approval is withheld for PAI
Routine inspection, Concise inspection, Follow-up inspection, Special inspection, Quality systems review
- Answer-5 types of inspection for pharmaceutical manufacturers
Routine Inspection - Answer-Full inspection of all applicable components of GMP and licensing
provisions
Routine Inspection - Answer-Indicated when the manufacturer is newly established
Routine Inspection - Answer-Indicated when the manufacturer requests renewal of LTO
Routine Inspection - Answer-Indicated when the manufacturer has introduced new product lines or new
products, or has made significant modifications on existing product/s, or has made changes in key
personnel, product, or equipment
