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…
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Quality Control
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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…
INVESTIGATION REPORT FOR THE OBSERVATION OF UNDER-DRYING OF GRANULES AT DRYING STAGE
During in-process testing at the post-drying stage, granules were found to have moisture content above the…
INVESTIGATION REPORT FOR THE OBSERVATION OF OVER-DRYING OF GRANULES IN FLUID BED DRYER
During in-process testing at the post-drying stage, the granules were found to have moisture content below the…
INVESTIGATION REPORT FOR THE OBSERVATION OF BLEND SEGREGATION
During routine blend uniformity sampling after transfer of lubricated blend to the quarantine area, significant…
INVESTIGATION REPORT FOR THE OBSERVATION OF GRANULATION MOISTURE CONTENT WAS FOUND OUT OF SPECIFIED LIMIT AFTER DRYING
During routine in-process testing at the granulation stage, the moisture content (LOD) of dried granules from…
INVESTIGATION REPORT FOR WATER BATH DAILY TEMPERATURE MONITORING RECORD WAS NOT AVAILABLE
Water baths are critical equipment used in pharmaceutical manufacturing laboratories and production areas for…
INVESTIGATION REPORT FOR ASSAY FAILURE OF RANITIDINE 150 MG TABLETS
• Product Name: Ranitidine 150 mg Tablet
• Batch Number: PGH/T/26-011
• Date of Incident: 18/02/26
• Company:…
INVESTIGATION REPORT FOR TREND ANALYSIS RESULT OF CONDUCTIVITY TEST FOUND OUT OF LIMIT DURING REVIEW OF PHASE III WATER REPORT
During the routine review of the Phase III purified water report, the Conductivity value was found out of the…
INVESTIGATION REPORT FOR CAPPING OBSERVED IN MULTIPLE TABLETS AFTER COMPRESSION STAGE
During routine in-process checks at the compression stage of Batch PGH/T/25-002, multiple tablets were observed…