Contract manufacturing organizations (CMOs) occupy a special niche in the bio/pharmaceutical industry and therefore face problems
not encountered by traditional bio/pharmaceutical manufacturing companies. One particular challenge facing CMOs is how to
define the responsibility for Quality in a relationship. Which party, the contract giver or the contract provider, has which
responsibilities? Although the answer may be straightforward for companies with their own manufacturing operations, it is
quite complicated for a CMO. When defining ownership of "Quality," a CMO must consider the compliance needs and regulatory
commitments for multiple clients. The CMO also must look at Quality as a function of product lifecycle—in a similar manner
to how their clients would look at Quality if they were manufacturing the product themselves.
THE BASIC EQUATION
If one views the Quality relationship as a simple mathematical equation, it may look something like this:
where A is the CMO needs, B is the compliance needs, C is the client's needs, D is regulatory commitments, and E is defined
as the elements of the Quality relationship. By analyzing this equation, it is clear that there are no constants, only variables.
Each variable is based on the consideration of certain elements from each party in the relationship.
Variable A: CMO Needs. A CMO's needs are based on maintaining as much operational consistency as possible when managing internal and subcontracted
resources. This approach enables cost management for the CMO and cost savings for the customer. Variable A should take into
account the audit, testing, sourcing, and customer-specific requirements needed to manufacture the product. The CMO should
make sure these requirements are included as part of the Quality Agreement. When defining auditing responsibilities, consideration
must be given to determining the appropriate involvement of the client for internal, external, and regulatory audits and should
be somewhat consistent between clients.
Testing requirements (e.g., final product, raw material, and environmental) should include what is required not only to manufacture
the product, but also to maintain the environment in which the product is manufactured. For example, testing requirements
might be traditional compendial testing, but may also include product-specific testing as defined by the client. In the case
of a raw material, the CMO must consider whether the item is used in multiple products and whether it is available from a
single or multiple sources. Consider this example: in some cases, the client may dictate the supplier of the component in
question because it has an established relationship. In other cases, the CMO may have the more established relationship with
the supplier. In such situations, the CMO, in conjunction with the client, must determine who will be responsible for providing
the qualification and follow-up audits of that supplier. This type of scenario should be defined in the Quality Agreement
so that there is little confusion between the parties. A well-drafted Quality Agreement can save a lot of confusion and duplication
of effort on behalf of the client and contract provider and facilitate productive communication.
Variable B: compliance needs. Multiple customers, regulatory agencies, and standard-setting organizations influence compliance requirements maintained by
a CMO. Each requirement needs to be implemented to accommodate the broad spectrum of these influences. Variable B of the equation
defines the compliance needs for the manufacture of all products at the given facility. Company standard operating procedures
(SOPs), customer SOPs, audit observations, and compendial requirements need to be considered in discussion with the client
and the CMO. Clients should make every effort to understand their CMO's SOPs.
It is equally important for the CMO to make sure that its SOPs are robust enough to accommodate multiple clients' needs. It
is difficult for a CMO with multiple clients to operate using duplicate SOPs for the same process or procedure. The CMO and
the client should therefore spend a sufficient amount of time ensuring that the compliance needs of both parties are defined
Similar to variable A, variable B also has an audit element to consider. In this case, the effectiveness and appropriateness
of a CMO's audit program is considered. The audit program must meet the regulatory expectations for internal and supplier
audits while also meeting the client's expectations on these points.