FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Validation Master Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows 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 per ASTM E2500, against a background of limited company resources (personnel, budget, time). A matrix simplifies “as-product”, “in-product”, process, and equipment, et al, software VT&V, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 are also considered.

Verification and validation requirements have always been part of the US FDA’s GMPs. 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, are not documented in a top tier Validation Master Plan, and may not be fully utilizing the power of current risk management tools, as identified in ISO 14971.The FDA / ICH Q-series provide valuable insights for all regulated industries, not just pharma.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, documented in a corporate VMP and implemented by other V&V documents.