AUDIT COMPLIANCE REPORT FOR VENDOR QUALIFICATION SYSTEM INADEQUATE
1. Context of Observation
During the WHO GMP inspection conducted at AABBCC Pharmaceutical Plant, the inspection…
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Audit Compliance
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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…
COMPLIANCE REPORT FOR NO PERIODIC QUALITY RISK MANAGEMENT (QRM) EXERCISES PERFORMED
During the WHO GMP inspection of a pharmaceutical plant, Name AABBCC, an observation was made that NO PERIODIC…
COMPLIANCE REPORT FOR QUALITY MANUAL NOT UPDATED AS PER CURRENT REGULATORY REQUIREMENTS
During the WHO GMP inspection of a pharmaceutical plant, Name AABBCC, an observation was made that the QUALITY…
COMPLIANCE REPORT FOR ROLES AND RESPONSIBILITIES OF QA AND QC ARE NOT CLEARLY DEFINED
During the WHO GMP inspection of a pharmaceutical plant, Name AABBCC, an observation was made that the ROLES AND…