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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Investigation Reports
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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 PRODUCT MIXUP
During routine in-process blister inspection on 05/12/2025, one red-coloured Methylcobalamin 1500 mcg tablet was…
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 CAPPING OBSERVED IN MULTIPLE TABLETS AFTER COMPRESSION STAGE
During routine in-process checks at the compression stage of Batch PGH/T/25-002, multiple tablets were observed…
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 BATCH RECORD ENTRIES THAT WERE NOT FILLED ONLINE
During an internal audit conducted on 27/11/2025, it was observed that:
• Activities for granulation and…
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 PRODUCT NAME ON SHIPPER LABEL
On 28/10/2025, during routine QA inspection of tertiary shippers for Batch PGH/T/25-002, it was observed that…
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…