FAILURE MODE AND EFFECTS ANALYSIS (FMEA) FOR TABLET THICKNESS OUT OF SPECIFICATION DURING COMPRESSION
Tablet compression is a critical manufacturing operation in which the prepared granules or powder blend are…
Browsing Tag
Quality Control
162 posts
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…
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…
CHANGE CONTROL REPORT REPLACEMENT OF RAPID MIXER GRANULATOR (RMG)
CHANGE CONTROL REPORT
1. SECTION-I : REQUEST FOR CHANGE
Change Control Number
CC/PROD/2026/RMG/001
Initiating…
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…
AUDIT COMPLIANCE REPORT USE OF EXPIRED RAW MATERIALS
During the WHO GMP inspection of the AABBCC pharmaceutical manufacturing facility, inspectors observed that…
AUDIT COMPLIANCE REPORT FOR CROSS-CONTAMINATION DURING DISPENSING
AUDIT COMPLIANCE REPORT FOR CROSS-CONTAMINATION DURING DISPENSING
1. Context of Observation
During the WHO GMP…
CHANGE CONTROL REPORT FOR CHANGE IN TESTING SPECIFICATION
CHANGE CONTROL REPORT
CHANGE IN TESTING SPECIFICATION
PRESENT / EXISTING PROCEDURE(S)
Testing of Paracetamol…
PERFORMANCE QUALIFICATION PROTOCOL CUM REPORT OF COLD STORAGE ROOM
The objective of the performance qualification is to demonstrate that the process as operated under
normal…