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Questions and Answers
What is the acceptance quality level (AQL) selected for visual inspection?
What is the acceptance quality level (AQL) selected for visual inspection?
- 1.0
- 0.8
- 0.65 (correct)
- 0.5
What type of defects are categorized as major?
What type of defects are categorized as major?
- Defects that carry risk of temporary impairment or medically reversible reaction (correct)
- Defects that are cosmetic in nature
- Defects that do not impact product safety or efficacy
- Defects that may cause serious ADR or death if the product is used
What determines the number of total samples to be collected for visual inspection process?
What determines the number of total samples to be collected for visual inspection process?
- Acceptance Quality Levels (AQL)
- Defect categorization
- Batch size and the level of inspection (correct)
- Type of product (ampoules/vials)
What type of defects are categorized as critical?
What type of defects are categorized as critical?
What is the reference for visual inspection of injections?
What is the reference for visual inspection of injections?
What is the purpose of Work Instruction: 5.1.1 AUTO INSPECTION PROCEDURE OF INJECTABLES IN AMPOULE AND VIALS (PSWB.003)?
What is the purpose of Work Instruction: 5.1.1 AUTO INSPECTION PROCEDURE OF INJECTABLES IN AMPOULE AND VIALS (PSWB.003)?
What determines the number of total samples to be collected for visual inspection process?
What determines the number of total samples to be collected for visual inspection process?
What are examples of defects categorized as major?
What are examples of defects categorized as major?
What is the AQL level selected for visual inspection?
What is the AQL level selected for visual inspection?
What is the purpose of General Inspection II referred to in the text?
What is the purpose of General Inspection II referred to in the text?
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