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
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
Sterilization EUGMP- Annex-1 Questions 1. Terminal sterilization is preferred because: A) It is faster than filtration B) It provides greater sterility assurance C) It requires no validation D) It uses fewer resources Answer: B Questions 2. When terminal sterilisation is not possible, one alternative is: A) UV sterilisation B) Post-aseptic processing terminal heat treatment C) Chemical … Read more
Moist Heat Sterilization EUGMP- Annex-1 1. Moist heat sterilization can be achieved using: A) Dry hot air only B) Steam (direct or indirect) C) UV radiation D) Gamma radiation Answer: B 2. Superheated water systems may be used for: A) Metal instruments B) Containers easily damaged by other cycles C) Rubber stoppers only D) Paper … Read more
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