INVESTIGATION REPORT FOR WATER BATH DAILY TEMPERATURE MONITORING RECORD WAS NOT AVAILABLE
Water baths are critical equipment used in pharmaceutical manufacturing laboratories and production areas for…
Browsing Tag
investigation
25 posts
INVESTIGATION REPORT FOR TREND ANALYSIS RESULT OF CONDUCTIVITY TEST FOUND OUT OF LIMIT DURING REVIEW OF PHASE III WATER REPORT
During the routine review of the Phase III purified water report, the Conductivity value was found out of the…
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…
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 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 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 LOW HUMIDITY OBSERVED DURING CAPSULE FILLING
During routine capsule filling operations for Batch No. PGH/T/25-002, the environmental monitoring system…
INVESTIGATION REPORT FOR THE WATER SANITIZATION FAILURE AS PER DEFINED FREQUENCY
As per the approved SOP, the purified water system is required to be sanitized once every 15 days using a…