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…
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Regulatory Compliance
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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)…
HOLD TIME STUDY PROTOCOL CUM REPORT FOR ITRACONAZOLE CAPSULE 100 mg
Hold time – The established time period for which dispensed raw materials, intermediates (in-process materials)…
Pharmaceutical Development report for the Ursodeoxycholic Acid Tablets BP 300 mg
A Product Development Report (PDR) for Ursodeoxycholic Acid 300 mg Tablets is a comprehensive technical document…
HOLD TIME STUDY PROTOCOL CUM REPORT FOR ACECLOFENAC PARACETAMOL & SERRATIOPEPTIDASE TABLETS
The established time period for which dispensed raw materials, intermediates (in-process materials) and bulk…
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…