Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the basics for maintaining an acceptable working relationship between a client and their CDMO.
Q. I work for a small company with a few products in the development phase. I am reviewing several contract development and manufacturing organizations (CDMOs) to determine which one best fits our needs. Can you give me some general guidance on what I should look for when choosing an appropriate partner?
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A. Contract manufacturing continues to be one of the fastest growing segments of the pharmaceutical industry. There are many small companies with products in development who do not own manufacturing facilities and must utilize CDMOs to handle their development and manufacturing needs from clinical to commercial product. It is important for both parties to be invested and respectful in the relationship because it is a long-term commitment.
The first step in this relationship is to establish a quality agreement (1–3). If we view the relationship between the two parties as an equation it would be:
A + B + C + D = E
A represents the CDMOs needs, B represents the client needs, C represents the compliance requirements, D represents the regulatory commitments for both parties, and E represents the quality agreement/quality relationship between the two organizations.
Breaking the equation down a bit more, variable: A should take into account the needs of the CDMO including auditing, testing, material sourcing, and any special client needs required to successfully manufacture the product. When defining the audit responsibilities, the CDMO should consider determining the amount of involvement of the client(s) for all audit types.
Variable B represents the client needs and should take into account requirements that might be influenced by development data, regulatory registration commitments, specific sourcing strategies, or any cooperative partnership with other companies. The client should also inform the CDMO of any additional quality agreements that are associated with the manufacturing of the product.
At one point in my career, I worked for a small start-up company which had three quality agreements associated with one product in clinical trials. The three agreements were for three different contract organizations. One CDMO organization was manufacturing the material, another was performing the release testing, and the final one was performing the product labeling. These complicated relationships should be disclosed to all involved parties so communication between organizations can be optimized, particularly when issues arise.
Variable C represents compliance requirements of the CDMO, which is influenced by multiple customers, regulatory agencies, and standard-setting organizations. Company standard operation procedures (SOPs) (4–6), client SOPs, audit observations, and compendial requirements define this element of our equation. Clients should be aware that CDMOs are usually global in nature and may have obligations to meet compendial requirements of the United States Pharmacopeia–National Formulary (USP–NF), the European Pharmacopoeia (Ph.Eur.), and the Japanese Pharmacopoeia (JP) (7).
In my opinion, this would be the optimal section to include the communication expectations for regulatory audits conducted either at the CDMO or the client’s business locations. The need for the CDMO to communicate with the client when a regulatory audit is being performed at their facility is evident, but it is equally important that the client communicates with the CDMO when the positions are reversed. This two-way communication is crucial because each organization could be vulnerable based on the audit outcome regardless of where the audit was conducted.
The final variable in this equation is variable D. Variable D considers the regulatory commitments of the client and/or the CDMO. Regulatory commitments are the evolving body of knowledge made up of new or impending regulations or guidelines that may require changes in operations in order to meet the expectations of the new requirements. A CDMO must communicate changes and commitments affecting their quality system to their client and vice versa because these changes may affect regulatory filings.
Finally, the solution to the equation is variable E, which represents the robust quality agreement. The quality agreement should be a living, breathing document that is reviewed and revised as often as needed to clarify both party’s responsibilities and avoid conflict of responsibilities to ensure a successful partnership.
The relationship between the client and the CDMO is important and complex. Both parties need to be knowledgeable on the application and interpretations of the regulations, and they need to work through any opposing opinions to reach an interpretation that works for both parties. A cooperative working relationship can be achieved if each party clearly identifies and communicates their needs through an effective quality agreement.
Vol. 46, No. 6
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