FAILURE MODE AND EFFECTS ANALYSIS (FMEA) FOR DISPENSED MATERIAL STORED UNDER INCORRECT CONDITIONS
FAILURE MODE AND EFFECTS ANALYSIS (FMEA) FOR DISPENSED MATERIAL STORED UNDER INCORRECT CONDITIONS…
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SOP
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FAILURE MODE EFFECT ANALYSIS REPORT FOR FIFO/FEFO SYSTEM IN WAREHOUSE
According to WHO Good Manufacturing Practices (WHO GMP), EU GMP Chapter 3 (Premises and Equipment), EU GMP…
INVESTIGATION REPORT FOR RELATIVE HUMIDITY (RH) WAS NOT CONSISTENTLY MAINTAINED
INVESTIGATION REPORT FOR RELATIVE HUMIDITY (RH) WAS NOT CONSISTENTLY MAINTAINED
Background
During the WHO GMP…
AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
1. Context of Observation
During the WHO…
AUDIT COMPLIANCE REPORT FOR FAILURE TO PERFORM WEIGHING VERIFICATION
During the WHO GMP inspection of AABBCC Pharmaceutical Plant, the inspection team observed that independent…
AUDIT COMPLIANCE REPORT INADEQUATE CLEANING OF DISPENSING BOOTH
During the WHO GMP inspection of AABBCC Pharmaceutical Plant, the inspection team observed that the cleaning of…
AUDIT COMPLIANCE REPORT FOR SOPs NOT REVISED PERIODICALLY
AUDIT COMPLIANCE REPORT FOR SOPs NOT REVISED PERIODICALLY
1. Context of Observation
During the WHO GMP…
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…