It’s clear from the number of Good Manufacturing Practice (GMP) warning letters related to laboratory compliance that the Food and Drug Administration (FDA) considers laboratory controls to be vital to the safety, quality, and efficacy of drug products. The laboratory is critical in developing and manufacturing drug products, from the approval of submission documents to the release of the final product. Choosing the best services and supplies for your lab is a key part of meeting the requirements of the GMP standards.
The various regulatory agencies have expectations that suppliers and vendors will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organization’s procedures state they will do. To be able to choose the highest quality supplies and services for their laboratories, it’s important for managers to know a few of the basics of auditing suppliers and vendors.
Related Article: Holding the Line on Good Laboratory Practices
Analytical instruments should be qualified and systems should be validated to demonstrate suitability for the intended use. Also helpful to lab managers is an overview of the regulatory background and getting guidance through the process from planning and writing requirement specifications to vendor assessment, installation and operational qualification, and ongoing testing during routine use. Finally, understanding the instrument qualification and system validation processes and gaining an idea of how to prepare for FDA audits and how to become 21 CFR part 11 compliant will all help make the GMP process smooth for lab managers.
When asking themselves what controls they should implement in an FDA regulated environment, laboratories should do a thorough review of GMP/GLP [Good Laboratory Practice] requirements. A look at current industry practice for labs which support clinical trials as well as those who provide quality control testing for commercial products, is also a good place to start when answering this question. In addition, calibration programs, analytical method validation, equipment qualification, control of standards and reagents, SOPs, documentation practices, outsourcing, training programs, and change control are all areas that need to be looked at when managers are choosing which controls to implement in their laboratories.
Be sure to attend Joy McElroy's Lab Manager Academy webinar, "Auditing Suppliers and Vendors/Qualifying Analytical Equipment," on Wednesday, May 4th, or afterward at www.labmanager.com/auditingsuppliers to watch the archived video.
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