Pharmaguidances Dry Heat Sterilization EUGMP- Annex-1 Questions 1. Dry heat sterilization uses high temperatures of: A) Water B) Steam C) Air or gas D) Infrared radiation Answer: C Questions 2. Dry heat sterilisation is particularly useful for removing: A) Viruses B) Moisture C) Endotoxin/pyrogen D) Organic solvents Answer: C Questions 3. Dry heat sterilisation is often … Read more
Sterilization by radiation and Sterilization with ethylene oxide (EO) EUGMP- Annex-1 Questions 1. Sterilization by radiation is mainly used for: A) Metal instruments B) Heat-resistant materials C) Heat-sensitive materials and products D) Liquids only Answer: C Questions 2. Which method is not acceptable as a sterilization method? A) Gamma irradiation B) Electron-beam irradiation C) Ultraviolet … Read more
Filter sterilization of products which cannot be sterilized in their final container EUGMP- Annex-1 Questions 1. Products that cannot be sterilized in their final container should be sterilized by: A) Heat sterilisation B) Gamma irradiation C) Filtration through a sterile sterilising-grade filter D) Autoclaving in bulk Answer: C Questions 2. The nominal pore size for … Read more
Form-Fill-Seal (FFS) Machines EUGMP- Annex-1 Questions 1. The environmental requirements for FFS machines used for terminally sterilized products are described in:A) Paragraph 8.10B) Paragraphs 8.3 and 8.4C) Paragraph 6.18D) Paragraph 8.22 Answer: B) Paragraphs 8.3 and 8.4 Questions 2. FFS machines used in aseptic manufacture should comply with environmental requirements of:A) Paragraph 8.3B) Paragraph 8.4C) … Read more
Blow-Fill-Seal EUGMP- Annex-1-Questions & Answers Questions 1. BFS equipment for terminally sterilized products should be installed in at least: A. Grade AB. Grade BC. Grade CD. Grade DAnswer: D Questions 2. The point of fill in BFS equipment should comply with: A. Paragraphs 8.3 and 8.4 environmental requirementsB. Only operator SOPsC. Packaging specificationsD. Regulatory limits for storageAnswer: … Read more
Lyophilization EUGMP- Annex-1 – Questions and Answers Questions 1. QC personnel supporting sterile manufacturing activities must have training and experience in: A. Marketing and financeB. Microbiology, sterility assurance, and process knowledgeC. Mechanical engineering onlyD. Warehouse operationsAnswer: B Questions 2. Specifications for raw materials, components, and products should include limits for: A. Moisture onlyB. Microbial, particulate, … 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
Environmental Monitoring – Total Particle Monitoring EUGMP- Annex-1 Questions 1. A total particle monitoring program should be established to: A. Reduce batch sizesB. Assess contamination risks and maintain sterile environmentsC. Replace viable monitoringD. Evaluate operator performanceAnswer: B Questions 2. Environmental monitoring limits for Grade D in operation are: A. Fixed by regulationB. Not predeterminedC. Same … Read more
Environmental and personnel monitoring – viable particle EUGMP- Annex-1 Questions 1. Microbial monitoring in aseptic operations should be: A. RareB. Performed only weeklyC. FrequentD. OptionalAnswer: C Questions 2. A combination of methods for microbial monitoring may include: A. Chemical analysisB. Settle plates, air sampling, glove, gown, surface samplingC. Weight measurementsD. Only visual inspectionAnswer: B Questions … Read more