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…
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Pharmaceutical industry
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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…
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 IMPROPER BINDER ADDITION AT GRANULATION STAGE
During routine monitoring of the granulation stage, it was observed that the granules showed non-uniform…
PROCEDURE FOR HANDLING OF ABNORMAL OBSERVATIONS AND SCADA ALARMS IN THE OPERATION OF PURIFIED WATER SYSTEM
Operate the purified water system as per SOPs.
During the system monitoring, if any mechanical snags are…
INVESTIGATION REPORT FOR PRODUCT MIXUP
During routine in-process blister inspection on 05/12/2025, two red-coloured Methylcobalamin 1500 mcg tablet was…
INVESTIGATION REPORT FOR THE OBSERVATION OF DIFFERENTIAL PRESSURE OUT OF LIMIT
During routine monitoring on 11/03/26, it was observed that the differential pressure between the Coating…
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…