One of the fundamental current good manufacturing practices (CGMPs) that medical device manufacturers implement are robust process validation procedures. Medical OEM manufacturers typically have deployed effective process validation systems in their operations; however, contract manufacturers may struggle to deploy effective process validation systems in their operations. The column provides a practical guideline on how to effectively implement a sustainable process validation program for contract manufacturers. A robust but practical process validation program can make a contract manufacturer achieve consistent, high-quality performance.
The quest for each manufacturer is to grow its business by establishing robust processes that yield consistent and reliable parts meeting customer drawing specifications and purchase order requirements. This statement sounds straightforward conceptually but can be a daunting task in practice. Having audited, managed, or consulted with over 100 factories in the last 20 years, I have found a common theme that defines top performing manufacturing plants. Top-performing manufacturers have practical and consistent methods in implementing, validating, and monitoring processes. Contract manufacturers can significantly improve the quality and consistency of their parts by having a robust and effective process validation program.
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.