ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 2.3: Define production's responsibilities in writing, from approved instructions and completed batch records to deviation reporting, clean facilities, calibration, maintenance and qualification

What does 2.3 require?

Production's responsibilities should be written down and should include at least: preparing, reviewing, approving and issuing production instructions under written procedures; making APIs, and intermediates where relevant, to pre-approved instructions; reviewing production batch records and making sure they are complete and signed; making sure every production deviation is reported and assessed, and that the critical ones are investigated with conclusions recorded; keeping production areas clean and disinfected where needed; making sure calibrations are done and recorded; keeping premises and equipment maintained with records; seeing that validation protocols and reports get reviewed and signed off; evaluating proposed changes to product, process or equipment; and making sure new or modified facilities and equipment are qualified where appropriate.