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
Questions and answers of Incident Procedure in Pharma EUGMP- Annex-1 Question 1. What is an incident as per the definition? A planned deviation B. An unplanned or uncontrolled event C. A customer complaint D. A routine process step Answer: B Question 2. Incidents occur due to: A. Market complaints B. System failure, equipment breakdown, or manual … Read more
Single-Use Systems (SUS) & Closed systems EUGMP- Annex-1 Questions 1. Single-use systems (SUS) are used as an alternative to: A. Terminal sterilizationB. Reusable equipmentC. Gowning systemsD. HVAC systemsAnswer: B Questions 2. SUS may consist of: A. Only filtersB. Only sensorsC. Individual components or multiple componentsD. Stainless-steel tanksAnswer: C Questions 3. SUS should be designed to … Read more
Environmental and Process Monitoring EUGMP- Annex-1 Questions 1. The purpose of an environmental monitoring programme is to ensure: A. Faster batch releaseB. That cleanrooms maintain appropriate air cleanlinessC. Operator competencyD. Media sterilityAnswer: B Questions 2. Environmental monitoring programmes must also: A. Increase product shelf lifeB. Detect excursions from environmental limitsC. Eliminate all viable particlesD. Replace … Read more