An article published this month by Susan J. Schniepp on BioPharm International illustrates the difficulty for contract manufacturing organizations (CMOs) in factoring in the quality priorities and needs of multiple clients into their own planning and operations. The article attempts to identify a formula that could help define the quality relationship more clearly between CMOs and their clients, namely how to balance the quality commitments and regulatory obligations of both parties involved.
Schniepp identifies four basic variables (and no constants) that contribute to the landscape of the CMO quality relationship:
1) CMO’s needs,
2) compliance needs,
3) client’s needs, and
4) regulatory commitments.
Each of these four variables must be weighed and considered when drafting a quality agreement, and each must be clearly identified and thoroughly explained within the document. According to Schniepp, “The Quality Agreement should be a living document that is reviewed and revised as often as needed to clarify the responsibilities of the client and the CMO as the product progresses through its lifecycle.” In order to sustain a successful relationship, both the CMO and its clients must be very clear on the elements required for quality and compliance, and where those responsibilities fall in each case. To read the full BioPharm article, click here.
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