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Before we evaluate an effective approach to process validation, it is important to understand the quality system requirements of validation. In the ISO 9001:2015 standard—Clause 8.5.1—on control of production and service provision, there is a requirement for you to have controlled conditions for “validation and periodic revalidation of the ability to achieve planned results of the processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement.” In regulated industries, such as aerospace and medical devices, specific process validation requirements are called out in AS9100D—aerospace standard—Clause 126.96.36.199 “Validation and Control of Special Processes,” and ISO 13485:2016—medical devices, quality management systems—Clause 7.5.6 “Validation of Processes for Production and Service Provision.”
The FDA made process validation a regulatory requirement in CFR 820.75(a), process validation with supplemental guidance for industry—Process Validation: General Principles and Practices, Current Good Manufacturing Practices (CGMPs). These standards and regulations provide general guidance on the requirements but do not specify how process validation should be implemented. Each manufacturer is required to develop its own methodology best suited to its manufacturing environment. This is where manufacturers have the opportunity to implement a sustainable and effective process validation program that not only meets compliance to the standards but provides value to the manufacturer in ensuring that a process yields consistent and reliable product quality.
Continue reading this column to learn how to implement an effective process validation program in the May 2019 issue of SMT007 Magazine.