Investigation Reports Quality Assurance (QA SOP) 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… PharmaGuide HubMarch 5, 2026No comments
Investigation Reports Quality Assurance (QA SOP) 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,… PharmaGuide HubJanuary 10, 2026No comments
Investigation Reports Quality Assurance (QA SOP) 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… PharmaGuide HubDecember 2, 2025No comments
Investigation Reports Quality Assurance (QA SOP) 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… PharmaGuide HubNovember 29, 2025No comments
HOLD TIME STUDY Quality Assurance (QA SOP) 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)… PharmaGuide HubNovember 25, 2025No comments
HOLD TIME STUDY Quality Assurance (QA SOP) 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)… PharmaGuide HubNovember 24, 2025No comments
PRODUCT DEVELOPMENT REPORT (PDR) Quality Assurance (QA SOP) 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… PharmaGuide HubNovember 22, 2025No comments
HOLD TIME STUDY Quality Assurance (QA SOP) 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… PharmaGuide HubNovember 18, 2025No comments
Investigation Reports Quality Assurance (QA SOP) 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… PharmaGuide HubOctober 31, 2025No comments
Investigation Reports Quality Assurance (QA SOP) 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… PharmaGuide HubOctober 24, 2025No comments