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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Pharmaceutical industry
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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 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 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 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 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…