Validation planning plays a key role in the qualification and validation of new equipment and processes. It is also used to plan and manage the ongoing validation requirements within companies. So why the need for validation plans? Firstly, the requirement for validation within medical device and pharmaceutical companies is a legal and regulatory one. The Food & Drug Administration (FDA) stipulates that validation is a regulatory requirement of Good Manufacturing Practices (GMP) for both pharmaceuticals (21 CFR 211) and medical devices (21 CFR 820). Validation plans act like a qualification plan that can be used to document strategies, test rationales and key deliverables. They are a regulatory requirement for medicinal products manufactured in the United States and Europe. 

Although not stated in 21 CFR Part 820 (Medical Devices) validation planning is an important activity that helps to document the validation strategy and deliverables and is common place with medical device manufacturers. In Europe, Eudralex (V4 GMP) is the collection of rules and regulations governing medicinal products in the European Union. This short ebook provides a general overview of validation plans and can be used as a quick reference or checklist when writing validation plans for projects, equipment or processes.

All equipment, processes, facilities and utilities that are GxP impacting need to be qualified. To facilitate the validation efforts, a Validation Plan (VP) creates a roadmap and structure to meet all validation requirements. For simple processes or simple equipment repair, a stand-alone validation plan may not be required and can be captured within a protocol or change control. The requirements of validation plans can be driven by a procedure which may be local to a site or factory or may be corporate and applicable to multiple sites. Consistency of requirements can also be managed by the use of an approved validation plan template.