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…
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PRODUCT NON CONFIRMANCE
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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 SMALL BROKEN GLASS PIECES IN AMPOULES
During routine in-process checks at the washing stage of ampoules for batch PGH/I/25-009 (Paracetamol…
INVESTIGATION REPORT FOR THE OBSERVATION OF RAW MATERIAL FROM UNAPPROVED VENDOR IN RM WAREHOUSE
On 08/09/2025, during standard dispensing checks in the dispensing area, the container label showed a vendor…
INVESTIGATION REPORT FOR THE BATCH WAS MANUFACTURED BEFORE THE API RELEASE STATUS WAS UPDATED IN THE SYSTEM
In GMP-regulated environments, no manufacturing process can begin until all raw materials and APIs are released…
INVESTIGATION REPORT FOR THE OBSERVATION OF RUBBER PIECES IN GRANULES AFTER BLENDING STAGE
On 01/08/25, during the post-blending inspection of the Pantoprazole 40 mg batch PGH/T/25-012, multiple small…
INVESTIGATION REPORT FOR LEAK TEST FAILURE OF BLISTER PACK
On 14/07/25, during routine in-process quality checks, a leak test was conducted on 10 blister packs of Calcium…