Premises – Cleanrooms and Sterile Manufacturing EUGMP- Annex-1 Questions 1. The manufacture of sterile products should be carried out in: A. Any closed roomB. Appropriate cleanroomsC. Open production areasD. Grade D rooms onlyAnswer: B Questions 2. Entry to cleanrooms should be through: A. Storage roomsB. OfficesC. Change rooms acting as airlocksD. Air-showers onlyAnswer: C Questions 3. Air supplied … Read more
Barrier Technologies in Pharma EUGMP- Annex-1 Questions 1. What is the primary purpose of isolators or RABS? A. To increase production speedB. To provide separation between Grade A and surrounding environmentC. To reduce staffing needsD. To improve HVAC efficiencyAnswer: B Questions 2. What should be minimized when using isolators or RABS? A. Machine noiseB. Entry/removal … Read more
Cleanroom and clean air equipment qualification in Pharma EUGMP- Annex-1 Questions 1. Cleanrooms and clean air equipment used for sterile products must be qualified according to: A. Market requirementsB. Required characteristics of the environmentC. Operator preferenceD. Equipment sizeAnswer: B Questions 2. The operational environmental cleanliness level is necessary to minimize: A. Equipment downtimeB. Personnel fatigueC. … Read more
Questions & Answers Disinfection in Pharma EUGMP- Annex-1 Questions 1. According to section 4.33, what is required before disinfection can be effective? A. Temperature controlB. Prior cleaning to remove surface contaminationC. Use of a sporicidal agentD. Personnel training Answer: B Questions 2. Cleanrooms should be cleaned and disinfected: A. Only during shutdown periodsB. Once a monthC. … Read more
Questions & Answers on Pharma Equipment EUGMP- Annex-1 Questions 1. According to section 5.1, what should be available as part of the initial qualification package? A. Equipment purchase invoicesB. A written, detailed description of the equipment designC. Cleaning and disinfection SOPsD. Environmental monitoring trend reports Answer: B Questions 2. What should be defined in the … 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