No. The original intent of Section 2.2 was to distinguish the main responsibilities (e.g., batch record review, review of non-conformances and investigations, sampling, testing, release or rejection of intermediate or API, etc.) of the independent quality unit from other departments within a company. Contract manufacturers are expected to have an independent quality unit that meet the responsibilities defined in [ICH Q7, Section 2.2] for all activities performed. Given the potential complexity of outsourcing contract manufacturing arrangements, GMP responsibilities should be clearly defined between both parties in detail in a written agreement [ICH Q7, Section 16.12]. However, the overall responsibility for API quality must not be delegated.
