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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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 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 IMPROPER BINDER ADDITION AT GRANULATION STAGE
During routine monitoring of the granulation stage, it was observed that the granules showed non-uniform…
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…
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…