BioOutsource

Technical Agreement

Under the current regulations it is the clients responsibility to clearly delineate, communicate and implement business, quality and compliance expectations to BioOutsource from the very beginning of the relationship, but we would seek to take dual responsibility for this. Thus a technical agreement is a written document between the client and the contract-testing organisation that defines in detail the quality and compliance expectations and responsibilities of each party that will be submitted for legal review.

A Technical Agreement plays an important role in ensuring quality and compliance to cGMP. A technical agreement clarifies the functional and technical aspects of a client relationship with BioOutsource. The technical agreement will delineate, in significant detail, the responsibilities of quality and personnel within each company. We seek with these documents to enhance the communication and build the confidence between the two parties and to ensure a seamless process for the release of product.

When an inspecting regulatory authority arrives at BioOutsource, our experience has shown that one of the first questions that will be asked is how responsibilities are divided between the staff at BioOutsource and the client, particularly concerning the communication routes and how both parties confirm cGMP compliance. We seek, with our Technical Agreement to quickly and accurately present a response to the investigator or auditor.

A typical technical agreement is composed of the major following sections:

  • Purpose and scope
  • Definitions
  • Responsibilities
  • Contact List
  • List of products covered under this agreement
  • List of Analytical Procedures or Methods covered under the agreement
  • Approval
  • Changes and revisions.
  • List of sub-contract analytical testing laboratories