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…
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SOP
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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 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 CAPPING OBSERVED IN MULTIPLE TABLETS AFTER COMPRESSION STAGE
During routine in-process checks at the compression stage of Batch PGH/T/25-002, multiple tablets were observed…
INVESTIGATION REPORT FOR THE OBSERVATION OF LESS CARTON IN PACKED SHIPPER
During routine QA inspection of finished goods at the end of the packing process, it was observed that one…
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…