Verification and validation requirements have always been part of the US FDA’s cGMPs. However, with increasing technology, both industry, and regulatory agencies' expectations have increased. Recent high-profile field problems indicate that V&V activities are not planned or carried out as completely as expected, and may not be fully utilizing the power of current risk management tools, as identified in ISO 14971. The billions of dollars spent by industry annually for V&V are not providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket science, but proper up-front V&V planning and execution. To assist in reaching these goals a Validation Master Plan is a must. The FDA expects a company to have one and follow it. Yet it's not specifically mentioned in the CGMPs. What is required of a VMP (or MVP)? Format? Contents? Sample entries? FDA and other regulatory expectations
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is the lack of sufficient or targeted risk-based company-wide master V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis/risk management allows the development of meaningful product validations. The roles of different V&V protocols. How to employ equipment/process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources (personnel, budget, time). A matrix simplifies “as-product”, “in-product”, process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 must be considered.
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years experience in U.S. FDA-regulated industries, 19 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.