Audit Compliance Uncategorized AUDIT COMPLIANCE REPORT FOR VENDOR QUALIFICATION SYSTEM INADEQUATE 1. Context of Observation During the WHO GMP inspection conducted at AABBCC Pharmaceutical Plant, the inspection… PharmaGuide HubMay 23, 2026No comments
Audit Compliance Quality Assurance (QA SOP) 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… PharmaGuide HubMay 19, 2026No comments
Audit Compliance Quality Assurance (QA SOP) AUDIT COMPLIANCE REPORT OF TREND ANALYSIS OF DEVIATIONS NOT PERFORMED Context of Observation During the WHO GMP inspection conducted at AABBCC pharmaceutical manufacturing facility,… PharmaGuide HubMay 15, 2026No comments
Audit Compliance Quality Assurance (QA SOP) 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… PharmaGuide HubMay 14, 2026No comments
Audit Compliance Quality Assurance (QA SOP) 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… PharmaGuide HubMay 13, 2026No comments
Audit Compliance Quality Assurance (QA SOP) 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… PharmaGuide HubMay 12, 2026No comments
Audit Compliance Quality Assurance (QA SOP) 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… PharmaGuide HubMay 11, 2026No comments
Audit Compliance Quality Assurance (QA SOP) 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… PharmaGuide HubMay 9, 2026No comments
Audit Compliance Quality Assurance (QA SOP) 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… PharmaGuide HubMay 8, 2026No comments
Audit Compliance Quality Assurance (QA SOP) 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… PharmaGuide HubMay 6, 2026No comments