Part II of this article covers the presentation that was held by Rebecca Devine, Ph.D, GMP Consultant, at the PDA/FDA Joint Regulatory Conference 2013 in Washington DC.
Rebecca Devine took a closer look at Quality Agreements from the industry´s point of view. Together with the FDA perspective featured in part I of this article we complete the 360° panoramic view on this important aspect related to outsourcing in the pharmaceutical industry.
The title of Rebecca Devine’s presentation was “Engaging Companies to Establish and Follow Quality Agreements“. The current situation is as follows:
Paula Katz, FDA, and Rebecca Devine agree on the regulatory requirements and references that were described in part I of this article.
It is of upmost importance to define the responsibilities and roles of each partner clearly. Rebecca Devine used synonyms for the client (owner, contract giver, applicant) and for the contract manufacturing organisation/CMO (contracted facility, contract acceptor).
In principle the responsibilities are:
It is a long-term relationship between the client and the CMO and in the early stage of a relationship both parties must develop a common understanding of the outsourcing procedures. It is crucial that each party recognizes each other’s responsibilities and agrees on the communication that is needed in this collaboration.
A standard procedure should include a due diligence visit, definition of a communication process, development of a Quality Agreement, request for references, elaboration of a risk assessment, and a comprehensive quality assurance audit.
To reach a common understanding is crucial since the client and the CMO do not always share the same goals but may have different objectives:
Because the goals may be different it is important that a Quality Agreement supports the understanding and communication. It should allow that various issues are being discussed and agreed upon ahead of time. The involvement of the Quality Units of both parties in the discussions is essential in all stages of an evolving relationship.
Rebecca Devine detailed the difference between a Manufacturing Services Agreement (MSA) and a Quality Agreement. The MSA is the legal contract of the services and it includes juridical issues such as ownership of technology, terms, indemnity, pricing, deliverables, timelines and responsibilities. She also pointed out that Quality Agreements are routine for most of the CMOs. Usually the MSA references the Quality Agreement and defines the relationship between the Quality Agreement and the MSA. Most often the MSA is executed prior to the Quality Agreement.
The Quality Agreement has to be finalized prior to the start of services. Typical areas of negotiations between the two parties are:
The table of content for a Quality Agreement could look like the following blue print:
To set up a proper Quality Agreement is one thing; the more challenging step is to follow the agreed provisions.
It goes without saying that it is critical to assure each party follows the Quality Agreement. Furthermore the following points are essential for a vital relationship between client and CMO:
Rebecca Devine stressed the aspect of communication which is, according to her experience, a key factor for a successful relationship.
She also highlighted the significance of the way of problem-solving especially for identified deviations and out of specification (OOS) situations.
In the case of deviations it is important to have a common understanding of the reporting procedures and to assure a team approach in solving deviations. The person in plant should help with his awareness. In deviations with critical impact the client should be involved in the review process of related deviations.
OOS situations should also be clarified in a Quality Agreement:
Another focus of the presentation was on the change control system because a change:
The possible impact on multiple clients makes the change management more complicated. In these cases it is crucial to communicate early to prevent delays.
Rebecca Devine recapped the main points of her presentation:
The two presentations of Paula Katz and Rebecca Devine were followed by a final discussion. Both speakers stressed the fact that communication is the key between Client and CMO.
Having a background as a consultant for the pharmaceutical industry for more than two decades I can only back up the demand for communication. I would like to conclude this article by quoting the American author Tony Robbins:
„To effectively communicate, we must realize that we are all different in the way we perceive the world and use this understanding as a guide to our communication with others.“
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