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Questions and Answers
What does the term 'manufacturing' include according to the guide?
What does the term 'manufacturing' include according to the guide?
- Packaging, labeling, and storage
- Quality control and release operations
- All operations from receipt of materials to distribution of APIs (correct)
- Only production and packaging
What is the purpose of the guide?
What is the purpose of the guide?
- To modify pharmacopoeial requirements
- To provide guidance on good manufacturing practice for APIs (correct)
- To define registration/filing requirements for APIs
- To cover safety aspects for personnel engaged in manufacturing
What does the term 'should' indicate in the guide?
What does the term 'should' indicate in the guide?
- Suggestions that can be ignored
- Optional best practices
- Mandatory requirements
- Recommendations expected to apply unless demonstrated otherwise (correct)
What does the guide not cover?
What does the guide not cover?
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What are the terms 'current good manufacturing practices' and 'good manufacturing practices' equivalent to in the guide?
What are the terms 'current good manufacturing practices' and 'good manufacturing practices' equivalent to in the guide?
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