Malegaon

Cleanroom and clean air equipment qualification in Pharma EUGMP- Annex-1

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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

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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

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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

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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

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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

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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

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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

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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

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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

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 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