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Regulatory Compliance, Quality, and GMP

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CHANGE CONTROL REPORT FOR CHANGE IN TESTING SPECIFICATION

CHANGE CONTROL REPORT CHANGE IN TESTING SPECIFICATION PRESENT / EXISTING PROCEDURE(S) Testing of Paracetamol…

PharmaGuide Hub

June 16, 2026

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2 min read

CHANGE CONTROL REPORT FOR CHANGE IN CALIBRATION FREQUENCY

CHANGE CONTROL REPORT: PRESENT / EXISTING PROCEDURE(S) Calibration of instruments is currently performed at…

PharmaGuide Hub

June 15, 2026

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CHANGE CONTROL REPORT FOR THE ADDITION OF NEW API VENDOR

PRESENT / EXISTING PROCEDURE(S) Currently, procurement of API is performed from approved vendors listed in the…

PharmaGuide Hub

June 13, 2026

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3 min read

CHANGE CONTROL FOR INSTALLATION OF MECHANICAL STIRRER FOR BINDER SOLUTION PREPARATION

Present/Existing Procedure(s): Currently, liquid binder solution preparation is carried out manually in the…

PharmaGuide Hub

June 12, 2026

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2 min read

Master Formula that was not approved

During the WHO GMP inspection conducted at the AABBCC pharmaceutical manufacturing facility, the following…

PharmaGuide Hub

June 11, 2026

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4 min read

INVESTIGATION REPORT FOR THICKNESS VARIATION OBSERVED IN TABLETS DURING COMPRESSION STAGE

Background During routine in-process quality checks performed during tablet compression, significant variation…

PharmaGuide Hub

June 10, 2026

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INVESTIGATION REPORT FOR LAMINATION OF TABLETS OBSERVED DURING COMPRESSION

Background During routine compression activities for Paracetamol 500 mg Tablets, operators observed separation…

PharmaGuide Hub

June 9, 2026

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4 min read

INVESTIGATION REPORT FOR THE OBSERVATION OF WEIGHT VARIATION BEYOND LIMIT DURING COMPRESSION

During routine in-process checks performed during compression of Paracetamol 500 mg Tablets, tablet weights were…

PharmaGuide Hub

June 8, 2026

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INVESTIGATION REPORT FOR THE OBSERVATION OF CAPPING DURING COMPRESSION

Background During routine compression of Paracetamol 500 mg Tablets, operators observed separation of the upper…

PharmaGuide Hub

June 6, 2026

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INVESTIGATION REPORT FOR PICKING OF TABLETS OBSERVED DURING COMPRESSION

Background During routine compression activity of Paracetamol 500 mg Tablets, operators observed that portions…

PharmaGuide Hub

June 4, 2026

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4 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