Managing Quality While Outsourcing - How to avoid the pitfalls of oursourcing - BioPharm International


Managing Quality While Outsourcing
How to avoid the pitfalls of oursourcing

BioPharm International

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.


  • Stuart Heir, Novartis Pharma AG
  • David Sherwood, Lonza Biologics, UK

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