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…
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Incident
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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…
INVESTIGATION REPORT FOR THE OBSERVATION OF SMALLER SHIPPER THAN STANDARD SIZE
During routine in-process inspection at the secondary packaging area on 03/11/2025, it was observed that one set…
INVESTIGATION REPORT FOR WRONG EXPIRY DATE PRINTED DURING SECONDARY PACKING STAGE
During in-process inspection on 27/10/2025, it was observed that the secondary carton of Calcium Carbonate 500…
INVESTIGATION REPORT FOR THE RECORDED OF WRONG FILL VOLUME
During the audit, it was identified that the line clearance and in-process check sheet indicated a fill volume…
INVESTIGATION REPORT FOR THE OBSERVATION OF DIFFERENTIAL PRESSURE OUT OF LIMIT
During routine monitoring on 11/10/25, it was observed that the differential pressure between the compression…
INVESTIGATION REPORT FOR THE OBSERVATION OF TEMPERATURE OUT OF LIMIT DURING COMPRESSION
During the in-process monitoring of the compression stage for Batch No. PGH/T/25-002, it was observed that the…
INVESTIGATION REPORT FOR THE OBSERVATION OF SMALL BROKEN GLASS PIECES IN AMPOULES
During routine in-process checks at the washing stage of ampoules for batch PGH/I/25-009 (Paracetamol…