Under QA responsibilities not to be delegated, approval of contract manufacturers was listed. The question is, what does this mean? What specific responsibilities does QA have to approve a contract manufacturer?

The API manufacturer’s Quality Unit is responsible for ensuring that the contracted facility is in
compliance with cGMPs for performing whatever activities have been contracted to them. If they
are performing, laboratory operations, they should be in compliance with the laboratory records
section and documentation of Q7A. If they are performing some kind o manufacturing activity,
they should be in compliance with cGMPs for that particular activity. A contractor becomes an
extension of the manufacturer’s facility and would be expected to comply with the appropriate
sections of Q7A.