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Pharmaceutical Manufacturing Processes Quiz

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Pharmaceutical Manufacturing Processes Quiz

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Questions and Answers

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?

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?

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?

Defects that may cause serious ADR or death if the product is used Signup and view all the answers

What is the reference for visual inspection of injections?

Visual Inspection of Injections (USP 1790) Signup and view all the answers

What is the purpose of Work Instruction: 5.1.1 AUTO INSPECTION PROCEDURE OF INJECTABLES IN AMPOULE AND VIALS (PSWB.003)?

To carry out 100% inspection for each ampoule/vial using an automatic inspection machine Signup and view all the answers

What determines the number of total samples to be collected for visual inspection process?

The batch size and the level of inspection Signup and view all the answers

What are examples of defects categorized as major?

Ampoules black spot, glass fragments, floating particles/fiber Signup and view all the answers

What is the AQL level selected for visual inspection?

0.65 as the defects are categorized as major Signup and view all the answers

What is the purpose of General Inspection II referred to in the text?

To determine the level of inspection based on batch size Signup and view all the answers

Pharmaceutical Manufacturing Processes Quiz

Choose a study mode

Podcast

Questions and Answers

What is the acceptance quality level (AQL) selected for visual inspection?

What type of defects are categorized as major?

What determines the number of total samples to be collected for visual inspection process?

What type of defects are categorized as critical?

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 determines the number of total samples to be collected for visual inspection process?

What are examples of defects categorized as major?

What is the AQL level selected for visual inspection?

What is the purpose of General Inspection II referred to in the text?

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