INVESTIGATION REPORT CAPSULE SHELL SOFTENING DUE TO HIGH HUMIDITY
INVESTIGATION REPORT
Capsule Shell Softening Due to High Humidity During Pharmaceutical Manufacturing…
Browsing Tag
AUDIT COMPILANCE
10 posts
AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED CORRECTIONS IN BATCH RECORDS
AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED CORRECTIONS IN BATCH RECORDS
1. Context of Observation
During the WHO…
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
1. Context of Observation
During the WHO…
AUDIT COMPLIANCE REPORT FOR FAILURE TO RECORD EQUIPMENT CLEANING
AUDIT COMPLIANCE REPORT FOR FAILURE TO RECORD EQUIPMENT CLEANING
1. Context of Observation
During the WHO GMP…
AUDIT COMPLIANCE REPORT FOR UNAPPROVED CHANGES IN MANUFACTURING PROCESS
AUDIT COMPLIANCE REPORT FOR UNAPPROVED CHANGES IN MANUFACTURING PROCESS
1. CONTEXT OF OBSERVATION
During the…
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 FOR LACK OF MANAGEMENT REVIEW OF QUALITY MANAGEMENT SYSTEM (QMS)
Response to WHO GMP Observation
Observation
Observation: Lack of Management Review of Quality Management System…
AUDIT COMPLIANCE REPORT FOR VENDOR QUALIFICATION SYSTEM INADEQUATE
1. Context of Observation
During the WHO GMP inspection conducted at AABBCC Pharmaceutical Plant, the inspection…
AUDIT COMPLIANCE REPORT FOR CHANGE CONTROL SYSTEM NOT PROPERLY IMPLEMENTED
During the WHO GMP inspection of a pharmaceutical plant, Name AABBCC, an observation was made that AUDIT…