Responsibility for Production Activities

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

-Preparing, reviewing, approving and distributing the instructions for the production of intermediates or APIs according to written procedures;

-Producing APIs and, when appropriate, intermediates according to pre-approved instructions;

-Reviewing all production batch records and ensuring that these are completed and signed;

-Making sure that all production deviations are reported and evaluated and that critical deviations are investigated and the conclusions are recorded;

-Making sure that production facilities are clean and when appropriate disinfected;

-Making sure that the necessary calibrations are performed and records kept;

-Making sure that the premises and equipment are maintained and records kept;

-Making sure that validation protocols and reports are reviewed and approved;

-Evaluating proposed changes in product, process or equipment; and

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