5 Questions
What does the term 'manufacturing' include according to the guide?
All operations from receipt of materials to distribution of APIs
What is the purpose of the guide?
To provide guidance on good manufacturing practice for APIs
What does the term 'should' indicate in the guide?
Recommendations expected to apply unless demonstrated otherwise
What does the guide not cover?
Safety aspects for personnel engaged in manufacturing
What are the terms 'current good manufacturing practices' and 'good manufacturing practices' equivalent to in the guide?
Mandatory regulations
Learn about good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) and the system for managing quality. Understand the requirements for quality and purity of APIs.
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