INVESTIGATION REPORT FOR PICKING OF TABLETS OBSERVED DURING COMPRESSION
Background
During routine compression activity of Paracetamol 500 mg Tablets, operators observed that portions…
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Incident
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INVESTIGATION REPORT FOR WEIGHING BALANCE CALIBRATION FAILURE OBSERVED DURING DISPENSING STAGE
During routine dispensing activity for batch PGH/L/XX-NNN, the weighing balance used for dispensing of raw…
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 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 MARKET COMPLAINT FOR MISSING OF ONE TABLET IN A STRIP OF DEXAMETHASONE TABLETS
On 20/02/2026, the company received a market complaint stating that one strip of Dexamethasone Tablets from…
INVESTIGATION REPORT FOR THE OBSERVATION OF ORANGE PEEL EFFECT OBSERVED DURING THE IN-PROCESS CHECK AT COATING STAGE
Background:
On 15/02/2026, during routine in-process inspection at the coating stage, tablets were visually…
INVESTIGATION REPORT FOR REFRIGERATOR DAILY TEMPERATURE MONITORING RECORD WAS NOT AVAILABLE
As per GMP requirements and company SOPs, refrigerators used for pharmaceutical raw materials, intermediates,…
INVESTIGATION REPORT FOR THE OBSERVATION OF DOUBLE TABLET PACKED IN A SINGLE BLISTER POCKET DURING PRIMARY PACKING
During in-process blister inspection on 04/12/2025, one pocket was observed to contain two tablets. The line was…
INVESTIGATION REPORT FOR THE OBSERVATION OF LESS CARTON IN PACKED SHIPPER
During routine QA inspection of finished goods at the end of the packing process, it was observed that one…