AUDIT COMPLIANCE REPORT FOR SOPs NOT REVISED PERIODICALLY
AUDIT COMPLIANCE REPORT FOR SOPs NOT REVISED PERIODICALLY
1. Context of Observation
During the WHO GMP…
Browsing Tag
SOP
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AUDIT COMPLIANCE REPORT INCORRECT SIEVE SIZE USED DURING MILLING
CONTEXT OF OBSERVATION
Product Details
• Product Name: XXXXX Tablets
• Batch Number: XXXXX
• Batch Size: XXXXX…
AUDIT COMPLIANCE REPORT IMPROPER QUARANTINE STATUS MANAGEMENT
Context of Observation:
During inspection, the inspectors identified the following deficiencies:
• Several…
SOP FOR RAW MATERIAL EXPIRY CONTROL AND FEFO MANAGEMENT SYSTEM
1. Receiving Raw Materials
Inspection at Receipt: Upon arrival, trained personnel must inspect and document each…
AUDIT COMPLIANCE REPORT FOR QUALITY AGREEMENTS MISSING WITH CONTRACT MANUFACTURERS
AUDIT COMPLIANCE REPORT FOR QUALITY AGREEMENTS MISSING WITH CONTRACT MANUFACTURERS
1. Context of Observation:…
CHANGE CONTROL REPORT FOR EXPANSION OF COMPRESSION AREA
CHANGE CONTROL REPORT FOR EXPANSION OF COMPRESSION AREA:
PRESENT / EXISTING PROCEDURE(S)
The existing…
CHANGE CONTROL REPORT FOR REVISION OF MASTER FORMULA RECORD (MFR)
CHANGE CONTROL REPORT FOR REVISION OF MASTER FORMULA RECORD (MFR):
PRESENT / EXISTING PROCEDURE(S)
The…
CHANGE CONTROL REPORT FOR CHANGE IN TESTING SPECIFICATION
CHANGE CONTROL REPORT
CHANGE IN TESTING SPECIFICATION
PRESENT / EXISTING PROCEDURE(S)
Testing of Paracetamol…
CHANGE CONTROL REPORT FOR CHANGE IN CALIBRATION FREQUENCY
CHANGE CONTROL REPORT:
PRESENT / EXISTING PROCEDURE(S)
Calibration of instruments is currently performed at…
CHANGE CONTROL FOR INSTALLATION OF MECHANICAL STIRRER FOR BINDER SOLUTION PREPARATION
Present/Existing Procedure(s):
Currently, liquid binder solution preparation is carried out manually in the…