Defined for each of these should be elements such as: the communication strategy for when events occur, the level of oversight
by the innovator, audit frequency and rights, approval rights, access to information systems and documentation, and a clear
definition of when issues need to be escalated to the client.
Additionally, the quality agreement should include the communication plan with regulatory authorities. This plan should clarify
the specific set of actions (and involvement) of the client during regulatory inspections at the CMO. It should also define
the appropriate structure for managing and responding to regulatory commitments.
A final part of the quality agreement should define ownership of regulatory filings and responsibility for notifying regulatory
authorities about changes.
The format of a quality agreement can vary. However, one needs to keep in mind that it will be referenced on a regular basis.
In many contract manufacturing relationships, certain products may be produced only a few times a year. As a result, the need
for a clear and useful document to remind both parties of the process for managing the manufacturing and release of product
is critical. There are several design elements that can help the quality agreement achieve this goal:
1. The document should be written in plain language. Not all of the individuals referencing the document will be quality (or
legal) experts.
2. It should be able to stand alone as a document. Even if it is included as an addendum to the overall supply agreement, it
may be referenced separately. There should be sections that summarize the scope of the document and the general relationship
between the parties.
3. It should include flow charts of key business processes, such as release and deviation investigations. These flow charts can
visibly show (through color coding or dividing lines) the path and ownership of certain process steps.
4. It should include a section with roles and responsibilities in tabular format. At a glance, parties can easily understand
where they fit in the overall process.
5. Areas of joint responsibility are further clarified in accompianing narative text associated with the tabular format.
The quality agreement is one of the most critical aspects of developing a strong relationship between a contract manufacturer
and an innovator company. By jointly developing this document, companies will take the first steps to defining a working relationship
built on a foundation of communication and negotiation. Although it is not yet a required element by every regulatory agency,
the quality agreement should be seen as key to any developing strategic relationship.
Acknowledgements:
- Stuart Heir, Novartis Pharma AG
- David Sherwood, Lonza Biologics, UK
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