Revolutionizing Pharmaceutical Industry

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Regulatory Compliance, Quality, and GMP

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INVESTIGATION REPORT FOR THE OBSERVATION OF GRANULATION MOISTURE CONTENT WAS FOUND OUT OF SPECIFIED LIMIT AFTER DRYING

During routine in-process testing at the granulation stage, the moisture content (LOD) of dried granules from…

PharmaGuide Hub

April 29, 2026

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4 min read

Engineering SOP (EG SOP)

PROCEDURE FOR HANDLING OF ABNORMAL OBSERVATIONS AND SCADA ALARMS IN THE OPERATION OF PURIFIED WATER SYSTEM

Operate the purified water system as per SOPs. During the system monitoring, if any mechanical snags are…

PharmaGuide Hub

April 28, 2026

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2 min read

INVESTIGATION REPORT FOR PRODUCT MIXUP

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

PharmaGuide Hub

April 27, 2026

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4 min read

INVESTIGATION REPORT FOR THE OBSERVATION OF DIFFERENTIAL PRESSURE OUT OF LIMIT

During routine monitoring on 11/03/26, it was observed that the differential pressure between the Coating…

PharmaGuide Hub

April 25, 2026

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3 min read

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…

PharmaGuide Hub

March 31, 2026

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4 min read

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:…

PharmaGuide Hub

March 24, 2026

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3 min read

INVESTIGATION REPORT FOR TREND ANALYSIS RESULT OF CONDUCTIVITY TEST FOUND OUT OF LIMIT DURING REVIEW OF PHASE III WATER REPORT

During the routine review of the Phase III purified water report, the Conductivity value was found out of the…

PharmaGuide Hub

March 7, 2026

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3 min read

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

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