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…
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INVESTIGATION REPORT FOR INCORRECT API DISPENSING OBSERVED DURING DISPENSING STAGE
During dispensing verification of raw materials for batch PGH/L/XX-NNN, it was observed that the quantity of…
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…
CHECKER VALIDATION PROTOCOL
PURPOSE:
The purpose of this document is to qualify, confirm and verify that the visual checkers consistently…
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 PRODUCT MIXUP
During routine in-process blister inspection on 05/12/2025, two red-coloured Methylcobalamin 1500 mcg tablet was…
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 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 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…