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
Regulatory Compliance
545 posts
INVESTIGATION REPORT FOR ASSAY FAILURE OF RANITIDINE 150 MG TABLETS
• Product Name: Ranitidine 150 mg Tablet
• Batch Number: PGH/T/26-011
• Date of Incident: 18/02/26
• Company:…
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 MARKET COMPLAINT FOR MISSING OF ONE TABLET IN A STRIP OF DEXAMETHASONE TABLETS
On 20/02/2026, the company received a market complaint stating that one strip of Dexamethasone Tablets from…
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 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 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…
HOLD TIME STUDY PROTOCOL CUM REPORT FOR DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL CHLORPHENIRAMINE MALEATE SYRUP
Hold time – The established time period for which dispensed raw materials, intermediates (in-process materials)…