안녕하세요.

EMA(European Medicines Agency)의 GMP/GDP IWG(Inspectors Working Group)에서 의약품 판매 허가 보유자(Marketing Authorisation Holders, MAH)의 GMP 책임을 요약한 Concept Paper를 발행하였습니다.

다음은 간단히 요약한 내용입니다.

• Chapter 1: responsibility to evaluate the results of the PQR review
• Chapter 7: responsibility to put contracts in place
• Chapter 8: responsibilities concerning quality defects, risk-reducing actions and notification of possible disruption in supply
• Annex 2: responsibility to put contracts in place
• Annex 12: obligations to approve the design of irradiation cycles, and agreeing the location for retention of irradiation cycle records.
• Annex 16: requirement to identify the site and QP responsible for certifying each batch (in the case of multiple sites authorised to manufacture / import / certify the same product) and the statement that the "ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy" lies with the MAH
• Annex 19: responsibilities for ensuring that reference and retention samples are taken, and stored.