Quality Assurance

Pharmaceutical Quality Risk Management: FDA & ICH Q9 Guide

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Quality Risk Management for New Products, Processes, Equipment, Facilities, Technology Transfer and Scale-Up   Introducing a new pharmaceutical product, manufacturing process, equipment, facility modification, technology transfer, scale-up activity, or process change can create significant quality risks. A change that appears technically simple may affect: Critical Quality Attributes (CQAs) Critical Process Parameters (CPPs) Material attributes Process capability … Read more

Pharmaceutical eQMS Digitalization FDA Compliance

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Pharmaceutical eQMS & Digitalization FDA Compliance: A Practical Guide for FDA-Regulated Companies Digital transformation is changing how pharmaceutical companies manage quality, compliance, documentation, and operational risk. For many years, pharmaceutical Quality Assurance departments relied heavily on paper-based systems, spreadsheets, email approvals, and manually maintained quality records. While these approaches can support basic operations, they can … Read more

Continual Improvement of the Pharmaceutical Quality System: A Practical FDA, ICH & PIC/S Framework

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Continual Improvement of the Pharmaceutical Quality System: A Practical FDA, ICH & PIC/S Framework A pharmaceutical quality system should do more than demonstrate compliance. It should enable an organization to identify emerging risks, understand process performance, learn from quality events, and continuously improve its operations. For pharmaceutical manufacturers supplying the United States, continual improvement should … Read more

Key Quality Systems in the Pharmaceutical Industry 

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Key Quality Systems in the Pharmaceutical Industry  A Pharmaceutical Quality Management System (PQMS) is a comprehensive framework designed to ensure that pharmaceutical products are consistently manufactured, tested, stored, and distributed to meet predefined quality, safety, efficacy, and regulatory requirements. It is based on the principles of ICH Q10 Pharmaceutical Quality System, WHO GMP, EU GMP, … Read more

SOP for Procedure for Assigning New Product Retest Date

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SOP for Procedure for Assigning New Product Retest Date 1.0 Objective To establish a procedure for assigning or extending the retest date of products based on stability data, ensuring product quality, safety, and compliance with regulatory requirements. 2.0 Scope This SOP is applicable to all finished products manufactured for which retest date assignment or extension … Read more

SOP for Loan License Product Manufacturing

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SOP for Loan License Product Manufacturing 1. Purpose To define the procedure for manufacturing, control, and release of products under a loan license arrangement, ensuring compliance with applicable GMP guidelines and regulatory requirements. 2. Scope This SOP applies to all products manufactured at the site under a loan license agreement for third-party (contract giver) companies. 3. … Read more

PREPARATION, REVIEW, CONTROL AND REVISION OF SITE MASTER FILE (SMF)

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PREPARATION, REVIEW, CONTROL AND REVISION OF SITE MASTER FILE (SMF) 1.0 OBJECTIVE To describe the procedure for preparation, review, approval, control, and revision of the Site Master File (SMF). 2.0 SCOPE This SOP is applicable to the preparation and maintenance of the Site Master File covering: Facility Premises Equipment Personnel Quality Management System Utilities 3.0 … Read more

Hazard Analysis and Critical Control Point – HACCP

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Hazard Analysis and Critical Control Point – HACCP 1.0 OBJECTIVE To lay down the procedure for conducting Hazard Analysis and Critical Control Point (HACCP) study to identify, evaluate, and control hazards that may affect the safety, quality, and efficacy of products. 2.0 SCOPE This procedure is applicable to all products manufactured at the facility and … Read more

SOP ON HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP)

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SOP ON HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP) 1.0 OBJECTIVE To lay down the procedure for conducting Hazard Analysis and Critical Control Point (HACCP) study to systematically identify, evaluate, and control hazards that may affect the safety, quality, and efficacy of products. 2.0 SCOPE This procedure is applicable to all products manufactured at the … Read more

SOP FOR HANDLING OF NON-CONFORMANCE OBSERVATION

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SOP for HANDLING OF NON-CONFORMANCE OBSERVATION 1.0 OBJECTIVE The purpose of this SOP is to establish a systematic procedure for identification, reporting, investigation, classification, control, and closure of non-conformances observed during product processing, and to prevent their recurrence in future manufacturing processes or product delivery. 2.0 SCOPE This procedure is applicable to all types of … Read more