The revisions – which are due to come into effect on January 31, 2013 – were issued by the EC Directorate-General for Health and Consumers late last week. They impact various aspects of drug quality, including outsourced manufacturing and biologic active pharmaceutical ingredients (API).
The changes range from the relatively minor – such as the replacement of the term ‘pharmaceutical quality assurance system’ with ‘pharmaceutical quality system’ – to the more significant – like the requirement that manufacturing contracts precisely detail which party is responsible for quality.
On the latter point the Commission is very clear which party is ultimately responsibility for ensuring good manufacturing practices (GMP) compliance.
“The pharmaceutical quality system of the Contract Giver should include the control and review of any outsourced activities. The Contract Giver is ultimately responsible to ensure processes are in place to assure the control of outsourced activities.”
The guidance states that before outsourcing production, the drugmaker issuing the contract must assess the legality, suitability and the competence of the contract manufacturing organisation (CMO) involved in terms of GMP compliance.
Firms outsourcing production must also provide the CMO with all the technical knowhow necessary to make the drug in accordance with GMP, let the contractor know of any potential hazards posed by the product and monitor to ensure that standards are maintained.
The third revision focuses on Annex 2 of the GMP guidelines, which covers the production of biological APIs.
The Commission said that guidelines have been “revised as a consequence of the restructuring of the GMP Guide, new manufacturing technology and concepts, the increased breadth of biological medicinal products to include several new product types such as transgenic derived products and the Advanced Therapy Medicinal Products, (ATMPs) together with associated new legislation.”