The quality component.
Managing quality properly can make or break a project. It can mean the difference between success and failure. Interestingly
enough, quality is frequently treated as an afterthought in contract manufacturing until it becomes critical for a manufacturing
date or for regulatory filing. Detail management becomes of key importance when supporting quality and regulatory components
for both sponsor companies and CMOs.
Managing the quality component
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So what is the best way to manage the quality side of your project? Take a perspective approach considering the requirements
of both sponsor company and CMO (see sidebar, "Managing the quality component").
From the sponsor company's perspective, start with understanding the quality systems at the CMO. Ask the question, "How do
they manage their quality systems?" Accept that there is always more than one correct approach to fulfilling CGMP requirements.
Content and execution are much more important than style. The question to ask is, "Can we live with the CMO's quality system
and does it fit with our regulatory strategy?" Given this information, it is helpful to remember that if the CMO has a solid
regulatory inspection history, then reasonable assurance exists that their quality systems are robust. Understanding what
type and how much regulatory experience the CMO has also gives a sense of security going forward. Consider how many preapproval
inspections the CMO has managed, the extent of their US and EU inspection history, the number of approved products the CMO
has on the market, and so forth. Once this background is established, allow the quality-system agreement to govern future
activities.
CMOs must ensure their quality systems are robust and that they cover all aspects of CGMP requirements.They must support training
of their staff and keep abreast of new industry standards, compendial changes, and new guidance as it becomes available. CMOs
should be a resource for their clients, and provide the customer service they would want and expect if they were the sponsor
companies.
Sponsor companies can help their CMOs by establishing expectations at the outset of the project and then allowing the CMO
to do their job. Listen to and consider CMO experience when making quality decisions. After all, the sponsor company is paying
for their expertise, so use it. Conversely, as the CMO, listen and consider the sponsor company's experiences. They have come
to you for a reason. Don't make them go it alone or relive negative experiences of the past.
A sponsor company should learn how the documentation system works at the CMO and familiarize itself with the CMO's batch-production
records and specification system. This preparation will ease document review throughout the project and may alleviate unwanted
surprises. Another critical point to consider is the need to understand how data will be managed and how the corrective and
preventive action system operates. Knowing the expectations of a sponsor company and the system of a CMO will ensure smooth
decision making if a deviation occurs.
Ultimately, it is the CMO's responsibility to train and guide its clients in the appropriate aspects of its quality systems.
Include customized requirements in the quality-system agreement. A word of caution, however, to both sides:out-of-the-ordinary
requirements may slow the project and increase costs. Flexibility and compromise, while maintaining the regulatory strategy,
should rule quality decisions, thereby saving time and money throughout the life of the project.
Regulatory functions
Regulatory functions
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Many sponsor companies that are new to contract manufacturing frequently ask about how and when regulatory functions fit into
the project, and they want to know what is important to the CMO and when is it required. As early in the project as possible,
provide the CMO with your product-development report. The information contained in this report will be worth its weight in
gold to the project and those supporting the cause.
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