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Tim Keutzer* is the director of project management at Cubist Pharmaceuticals, 65 Hayden Ave., Lexington, MA 02421, tel. 781.860.8331, fax 781.860.1131.
Howard Silver is the manager of GMP compliance at Cubist Pharmaceuticals.
The authors provide detailed lists of important checkpoints to consider when selecting an outsourcing provider.
Whether for reasons of risk management, capacity requirements, capital limitations, or lack of available human resources, pharmaceutical companies are increasingly entering into outsourcing relationships for the management of their supply chains. Outsourcing allows a company to realize the benefits of production and sales without maintaining infrastructure or making large capital investments. Although such relationships are advantageous, the pharmaceutical company entering into them retains ultimate responsibility for the quality of its compound. Therefore, careful consideration must be given in the selection and review of an outsourcing provider to ensure compliance.
A company must first determine whether outsourcing is needed. The answer can be as simple or as complex as a given supply chain and may comprise several answers. The company must make a clear-eyed evaluation of its strengths and weaknesses, its available resources, and its risk tolerance to develop an outsourcing model that is applicable to its unique situation. For companies in need of outsourcing, this article serves as a guide for selecting where outsourcing should take place.
Selecting an outsourcing provider
The factors to consider when selecting an outsouring provider and the relevant questions a company should ask include the following:
The first stage in entering into outsourcing, then, is ensuring that a potential partner has the infrastructure, experience, and financial health to provide assurance that the project will succeed. It will do no good if the company has excellent systems and equipment but is ready to shut its doors because of a lost contract. Conversely, a company with a strong balance sheet may not have the right experience that would be required. More, a sponsor company and its competition may arrive at the same conclusion, and so the sponsor's information must be protected and product supply needs must be ensured. With these answers, the sponsor company can proceed with confidence to evaluating the compliance capabilities of the supplier.
Each product and process is different. Therefore, ensuring compliance in an outsourced model must take into account the specific needs of the product in the context of GMPs and other relevant regulations.
In the United States, for example, the US Food and Drug Administration expects drug, medical device, and biologics manufacturers to have an active facility and supplier audit program, even though there are no specific requirements in the regulations that show that audits of the quality systems have been conducted. Although the word audit is not included in 21 CFR Parts 210 and 211, the requirement for and responsibilities of a "quality control unit" are nonetheless elucidated. FDA currently takes a systems approach that includes the quality system, facilities and equipment, materials management, production, packaging and labeling, and laboratory controls. The elements of these systems are defined in 21 CFR 211 and in the various FDA guidances and should be included in the audit.
Audit checklists can cover all areas of production, from the receipt of raw materials to final release of product, as well as support systems and controls. Or, they can be custom made by the auditor to ensure that each term in the audit plans is specifically addressed. The following are a sample checklists an auditor might use to perform a GMP lab audit.
Quality assurance oversight
Atypical and OOS results
Documentation control and approval
Internal quality and GMP audit program
Facility layout and design
Environmental control program
Organized sample storage, material and component control
Laboratory chemicals, solutions, and reagents
Standards, testing, and methods
During the course of routine production, and as governed by the quality agreement, the sponsor will perform routine audits to ensure continued compliance. With a solid baseline established during the selection phase, the sponsor can then focus on areas where risk to product quality is highest. By properly selecting, evaluating, and monitoring a third-party supplier, the sponsor can ensure continued compliance over the longterm.
Tim Keutzer* is the director of project management at Cubist Pharmaceuticals, 65 Hayden Ave., Lexington, MA 02421, tel. 781.860.8331, fax 781.860.1131, firstname.lastname@example.org. Howard Silver is the manager of GMP compliance at Cubist Pharmaceuticals.
*To whom all correspondence should be addressed.