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By year end 2010, FDA is planning to release new regulations that will include requirements for Pharmaceutical manufacturers to physically audit their vendors, no longer allowing paper audits to be acceptable. This change is being considered because of the large number of gaps being found in manufacturers’ quality systems due in part to the growth of production outsourcing. It is expected that once the drafting process of these proposed regulations is completed, they will be available for review and comments for approximately three to six months.
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| Brian Hasselbalch |
According to Brian Hasselbalch, representing the Office of Compliance’s Division for Manufacturing and Drug Product Quality within FDA’s Center for Drug Evaluation and Research, at a conference held jointly by the agency and Xavier University in Cincinnati, Ohio, June 13-16, “between 2001 and 2007, the number of products manufactured outside the United States and the number of manufacturing sites abroad doubled. Some of the new products being imported into the US come from countries with less developed regulatory systems.”
As indicated in the U.S. Food and Drug Administration (FDA) Guidance for Industry Q10 Pharmaceutical Quality System, which is in accordance with 21 CFR Part 820.50, Pharmaceutical companies are ultimately responsible for ensuring that processes are in place to assure the control of outsourced activities and quality. In doing so, companies should implement processes to access the suitability and competence of a vendor prior to outsourcing operations or selecting them as a vendor. This can be accomplished by establishing approved procedures, performing audits, and ensuring qualifications. Note that defined quality requirements should be used during the auditing process to ensure the vendor is capable of meeting these requirements. The evaluation results should be documented.
If it is determined that the vendor is qualified, an approved, written agreement, often referred to as a Quality Agreement, that defines quality requirements, responsibilities, and communications necessary for quality-related activities, should be created and approved between the two parties. Records of acceptable vendors should be established and maintained via an Approved Vendor List.
If a company does not have an Approved Vendor List, it cannot be concluded that vendors being used by the company are qualified to provide the products and services being used for cGxP purposes. With the establishment of an Approved Vendor List, a company can work smarter, not harder. A company will be able to determine if a qualified vendor is currently available that can provide the necessary products or services instead of going through the entire qualification process each time a new vendor is needed. It also ensures that several vendors are not being used for identical products or services. In the end, this will result in better utilization of resources, an improved state of regulatory compliance, and a cost reduction for the company.
However, having these procedures in place does not ensure proper implementation of them. Training should be conducted and documented on these approved procedures, emphasizing the need for quality in all aspects of the vendor qualification process including ensuring that all required vendor assessment and auditing documentation is stored in a centralized, secure location.
A vendor audit does not have to be conducted by a company representative. It is acceptable to use contracted resources to perform these audits as long as the resources are qualified to perform the tasks and the qualifications are documented. According to Hasselbalch, “We will not demand that you individually audit. We acknowledge and recognize a surrogate or a third party audit arrangement. It may be more efficient and more effective, quite honestly. A third party audit would have to be performed by a credible auditing arm [with] certain characteristics that assure the integrity and the quality of the audits.”
Refer to the links below for FDA MedWatch reports relevant to outsourcing.
