Variable D: regulatory commitments.
Regulatory commitments are an evolving body of knowledge that may necessitate flexibility to adapt to CMO and client interpretations
of new or impending regulations. Variable D considers the regulatory commitments of the client and/or the CMO. CMOs can indicate
which regulatory authorities have audited their facilities, when they were last audited, and the outcome of these audits.
A CMO must also communicate to their clients the changes and commitments made to their Quality Systems based on the responses
to the regulatory audits because these changes may affect the regulatory filings of the clients. Each client will have its
own interpretation of how to comply with the audit observation and what filing strategy should be used to update their filings,
The CMO must ensure that its responses to regulatory audits do not jeopardize any of their clients' commitments. On the other
hand, clients must communicate with the CMO regarding commitments they have made in their registrations. Among other information,
they should disclose to the CMO whether they are using novel excipients as opposed to compendial excipients and whether any
special specifications or testing must be performed.
Variable E: The Quality Agreement.
The solution to the equation noted above (A+B+C+D) is E, which represents Quality as a function of product lifecycle. The
document that contains the information defining the various responsibilities that comprise E is the Quality Agreement. This
master document should define the CMO's needs, the client's needs, the compliance needs for the product and both parties,
and any pertinent regulatory commitments. 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.
The Quality Agreement is akin to a marriage license between two parties and should clearly identify the roles and responsibilities
needed for a successful partnership.
In general, Quality Agreements are legally binding agreements between the Quality functions of the contract provider and the
contract giver. Many companies use a matrix approach for defining these activities which can include but are not limited to
compliance, manufacturing, packaging and labeling, documentation, change control, nonconformance, out of specification (OOS),
deviations, complaints, recalls, and auditing. Each document should be tailored to address the expectations of the specific
operations to be undertaken by the CMO as well as external actions that may have an impact on those operations. Clients and
CMOs should communicate frequently to make sure that the product being manufactured meets the necessary specifications required
to meet the minimum Quality requirements. In order for the relationship between the client and the CMO to be effective, the
two parties should communicate often.
Defining the Quality relationship between a CMO and a client is complex and requires extensive discussion and attention to
detail. The relationship should be open and communication between the two parties should be as frequent as required to assure
that the product being manufactured meets the highest Quality standards for the client and for the patients.
Susan J. Schniepp is vice-president of Quality at OSO Biopharmaceuticals and a member of the PharmTech Editorial Advisory Board, firstname.lastname@example.org