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 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 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) 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 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) 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 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
SOP FOR CONTAMINATION CONTROL STRATEGY (CCS) 1.0 OBJECTIVE 1.1 To describe the procedure for establishing, implementing, and maintaining a comprehensive Contamination Control Strategy (CCS) to ensure that risks of microbial, particulate, and endotoxin/pyrogen contamination are systematically identified, evaluated, controlled, monitored, and continuously improved in accordance with the principles of EU GMP Annex 1. 2.0 SCOPE … Read more
Key checklist of WHO TRS 1044-annex-2 For products that have been filled aseptically, samples should include containers filled at the beginning and end of the batch. Additional samples (for example, taken after critical interventions) should be considered based on risk. For products that have been heat sterilized in their final containers, samples taken should be … Read more
Pharmaceutical Quality System (PQS) Questions 1. The manufacture of sterile products requires: A. Minimal controlsB. Specific controls and measuresC. Only visual inspectionD. No specialized systemsAnswer: B Questions 2. The primary goal of the PQS for sterile products is to: A. Increase production speedB. Minimize microbial, particulate, and endotoxin/pyrogen contaminationC. Reduce documentationD. Eliminate the need for … Read more