GMP for API Manufacturing 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

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

Suggestions that can be ignored

Optional best practices

Mandatory requirements

Recommendations expected to apply unless demonstrated otherwise (correct)

<p>Safety aspects for personnel engaged in manufacturing</p> Signup and view all the answers

<p>Mandatory regulations</p> Signup and view all the answers