In the case of a contract manufacturer producing an API for a client abroad, must the process be validated entirely by the contractor or can it be partly done by both parties?

API manufacturers are expected to validate critical process steps that are critical to the quality
and purity of the API. Neither Section 12 nor 16 specifies the responsibilities of either party. This
should be decided upfront and specified in the written contract or formal agreement between the
company and its contractor, as specified in Section 16.