INVESTIGATION REPORT FOR STICKING OF TABLETS TO PUNCHES OBSERVED DURING COMPRESSION STAGE
During routine tablet compression of Paracetamol 500 mg Tablets, operators observed granule material adhering to…
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INVESTIGATION REPORT
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INVESTIGATION REPORT FOR CROSS-CONTAMINATION OBSERVED BETWEEN PRODUCTS DURING GRANULATION STAGE
During routine in-process inspection at the granulation stage, foreign granules with different color and…
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…
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…
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…