Master Formula that was not approved
During the WHO GMP inspection conducted at the AABBCC pharmaceutical manufacturing facility, the following…
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Audit Compliance
14 posts
PERFORMANCE RE-QUALIFICATION PROTOCOL CUM REPORT OF COMPRESSED AIR
The purpose of carrying out Performance Re-Qualification of Compressed Air System is to establish the documented…
PROTOCOL COM REPORT FOR PRESSURE DIFFERENCE QUALIFICATION
To determine the procedure for Pressure difference qualification and to establish that desired quantity of air…
AUDIT COMPLIANCE REPORT FOR VENDOR QUALIFICATION SYSTEM INADEQUATE
1. Context of Observation
During the WHO GMP inspection conducted at AABBCC Pharmaceutical Plant, the inspection…
INVESTIGATION REPORT FOR THE OBSERVATION OF SIFTER MESH DAMAGE DURING GRANULE SIFTING OPERATION
Background
During routine granule sifting operation using the vibratory sifter, the operator observed abnormal…
AUDIT COMPLIANCE REPORT OF TREND ANALYSIS OF DEVIATIONS NOT PERFORMED
Context of Observation
During the WHO GMP inspection conducted at AABBCC pharmaceutical manufacturing facility,…
AUDIT COMPLIANCE REPORT PRODUCT QUALITY REVIEW (PQR) NOT PREPARED ANNUALLY
During the WHO GMP inspection of a pharmaceutical plant, Name AABBCC, an observation was made that AUDIT…
AUDIT COMPLIANCE REPORT OF NO DEFINED QUALITY METRICS OR KPIs
During the WHO GMP inspection of a pharmaceutical plant, Name AABBCC, an observation was made that AUDIT…
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…
COMPLIANCE REPORT FOR CAPA SYSTEM WAS INEFFECTIVE, AND REPEAT DEVIATIONS WERE OBSERVED
During the WHO GMP inspection of a pharmaceutical plant, Name AABBCC, an observation was made that CAPA SYSTEM…