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…
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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 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 UNAVAILABILITY OF DAILY TEMPERATURE MONITORING RECORD FOR REFRIGERATOR
As per GMP requirements and company SOPs, refrigerators used for pharmaceutical raw materials, intermediates,…
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 FLY KILLER NEAR DISPENSING AREA WAS NOT IN WORKING CONDITION
Fly killers are installed in manufacturing and dispensing areas to control insect contamination and maintain a…
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 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…