Do the responsibilities not to be delegated by QA apply to both clinical and commercial APIs? For example, do manufacturing instructions require QA approval prior to commencement of the manufacturing step?

Responsibilities not to be delegated apply to both except where Section 19 indicates otherwise.
Manufacturing instructions is one of the areas where expectations are specifically different for
APIs intended for use in clinical trials. Section 19 states that the expectation for documentation is
different for clinical materials. It does not call for a Batch Production Record. It states,
“Production can be documented in laboratory notebooks, batch records, or by other appropriate
means.” It is the role of the quality unit to ensure that appropriate documentation is kept.