Changes to European GMP guidelines designed to align them with ICH Q10 have significant implications for CMO contracts.
The European Commission Directorate-General for Health and Consumers (DG-SANCO) issued three revisions to its good manufacturing practices (GMP) guidelines last week, which impact various aspects of drug quality 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.
Additionally, firms outsourcing production must 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 guidelines also set requirements for contract manufacturing organisations (CMO), the foremost of which is that they are capable of doing the work to the required standards.
“The Contract Acceptor must be able to carry out satisfactorily the work ordered by the Contract Giver such as having adequate premises, equipment, knowledge, experience, and competent personnel.” CMOs are also required to make sure all materials, products and technical knowhow transferred to it by clients and suppliers are fit for purpose.
Subcontracting to other CMOs is prohibited without written consent from the company that outsourced the work and similarly contractors are not allowed to make changes to the work outlined in the original contract if they impact quality of the finished product.