Revolutionizing Pharmaceutical Industry

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Regulatory Compliance, Quality, and GMP

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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…

PharmaGuide Hub

March 6, 2026

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4 min read

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 Hub

March 5, 2026

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3 min read

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 Hub

January 10, 2026

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3 min read

INVESTIGATION REPORT FOR PRODUCT MIXUP

During routine in-process blister inspection on 05/12/2025, one red-coloured Methylcobalamin 1500 mcg tablet was…

PharmaGuide Hub

December 5, 2025

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3 min read

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…

PharmaGuide Hub

December 4, 2025

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3 min read

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 Hub

December 2, 2025

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3 min read

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 Hub

November 29, 2025

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3 min read

INVESTIGATION REPORT FOR THE OBSERVATION OF BATCH MANUFACTURING RECORD (BMR) & BATCH PACKAGING RECORD (BPR) ENTRIES THAT WERE NOT FILLED ONLINE

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…

PharmaGuide Hub

November 28, 2025

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3 min read

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 Hub

November 25, 2025

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3 min read

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 Hub

November 24, 2025

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2 min read

Revolutionizing Pharmaceutical Industry

Empowering Pharma Excellence: Your Ultimate Guide to Regulatory Compliance, Quality, and GMP

Empowering Pharma Excellence: Your Ultimate Guide to
Regulatory Compliance, Quality, and GMP