Responsibility for Production Activities

The responsibility for production activities should be described in writing and should include, but not necessarily be limited to:

1. Preparing, reviewing, approving, and distributing the instructions for the production of

intermediates or APIs according to written procedures 

2. Producing APIs and, when appropriate, intermediates according to pre-approved

instructions

3. Reviewing all production batch records and ensuring that these are completed and signed

4. Making sure that all production deviations are reported and evaluated and that critical

deviations are investigated and the conclusions are recorded

5. Making sure that production facilities are clean and, when appropriate, disinfected

6. Making sure that the necessary calibrations are performed and records kept

7. Making sure that the premises and equipment are maintained and records kept

8. Making sure that validation protocols and reports are reviewed and approved

9. Evaluating proposed changes in product, process or equipment

10. Making sure that new and, when appropriate, modified facilities and equipment are

qualified