WHO GMP for Sterile Pharmaceutical Products Clean Areas & Facilities Question 1. Sterile preparation production should be carried out in: A. Open manufacturing spacesB. Controlled warehousesC. Clean areasD. Regular production roomsAnswer: C Question 2. Entry to clean areas should occur through: A. Free-access doorsB. AirlocksC. Emergency exitsD. Storage roomsAnswer: B Question 3. Air supplied to … 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
Personnel EUGMP- Annex-1 Question 1. The manufacturer must ensure there are sufficient personnel who are: A. Newly hiredB. Qualified, trained, and experiencedC. Working part-timeD. Only externally certifiedAnswer: B Question 2. Personnel must be trained in the manufacture and testing of: A. Veterinary products onlyB. Sterile productsC. CosmeticsD. Medical devicesAnswer: B Question 3. Only the ______ number of … Read more
Questions & Answers Utilities, Water Systems, Steam, Gases, and Heating/Cooling Systems EUGMP- Annex-1 Question 1. The level of controls applied to utility systems should be based on: A. Historical dataB. Auditor preferenceC. Risk to product qualityD. Cost of maintenance ANSWER – C Question 2. Utility system impact must be assessed and documented as part of the: A. Preventive … Read more
Terminally Sterilized Products EUGMP- Annex-1 Question 1. Preparation of components and materials for terminally sterilized products should be performed in at least: A. Grade AB. Grade BC. Grade CD. Grade DAnswer: D Question 2. The purpose of using at least a Grade D room for preparation is to limit: A. Temperature deviationB. Microbial, endotoxin/pyrogen, and particle contaminationC. … Read more
Examples of operations and grades for aseptic preparation and processing operations EUGMP- Annex-1 Question 1. Which activity is performed in Grade A? A. Cleaning of equipmentB. Aseptic compounding and mixingC. Preparation of solutions to be filteredD. Handling of components after cleaningAnswer: B Question 2. Aseptic assembly of filling equipment belongs to which grade? A. Grade DB. … Read more
Aseptic Preparation and Processing in Pharma EUGMP- Annex-1 Question 1. The aseptic process should be: A. Informal and flexibleB. Clearly definedC. Performed without documentationD. Determined only by productionAnswer: B Question 2. Risks associated with the aseptic process should be: A. Ignored unless criticalB. Identified, assessed, and controlledC. Controlled only by QAD. Evaluated only onceAnswer: B Question 3. Accepted … Read more
Sterile Product Finishing EUGMP- Annex-1 Questions 1. Open primary packaging containers must be maintained under which conditions? A. Grade BB. Grade CC. Grade AD. Grade DAnswer: C Questions 2. Final containers should be closed using: A. Any available methodB. Manually approved methodsC. Appropriately validated methodsD. Vendor-recommended methods onlyAnswer: C Questions 3. Containers closed by fusion include: A. … 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
Sterilization by Heat EUGMP- Annex-1 1. Each heat sterilization cycle should be recorded: A. Only in handwritten logsB. Either electronically or by hardcopyC. Only when deviations occurD. Only if requested by inspectorsAnswer: B 2. Control and monitoring systems for heat sterilisation should include: A. No redundancyB. Only visual indicatorsC. Safeguards and/or redundancy to detect non-conforming … Read more