Issue link: https://iconnect007.uberflip.com/i/1111672
64 SMT007 MAGAZINE I MAY 2019 ciples and Practices, Cur- rent Good Manufacturing Practices (CGMPs)." These standards and regulations provide general guidance on the requirements but do not specify how process validation should be imple - mented. Each manufac- turer 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 compli - ance to the standards but provides value to the man- ufacturer in ensuring that a process yields consistent and reliable product quality. How do you implement an effective process validation program? Let's first understand the difference between pro- cess validation and process verification. One approach is to understand how the FDA defines these requirements. Per the Code of Federal Regulations, Title 21—Food and Drugs, Part 820, quality system regulations: • Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled [CFR 21 Part 820.3(z)] • Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled [CFR 21 Part 820.3(aa)] When these definitions are applied to a man- ufacturing operation, we conclude that not all processes can be verified. In theory, you could conceivably validate all processes, but that's not cost effective nor practical for the orga - nization. Process validation should only be applied to those processes where process ver- ification cannot be accomplished (Figure 1). Typical processes that require validation are heat treating, cleanroom ambient conditions, plating, plastic injection molding, sterilization, and packaging sealing processes. The man- ufacturer should prepare a table that lists all processes with defined measures for each pro- cess as illustrated in Figure 2. Processes that require process validation should undergo a robust validation program, using validation protocols for each phase. The validation phases include: • Installation qualification (IQ): This validation phase verifies that the instru- ment or equipment being qualified—as well as its subsystems and any ancillary systems—have been delivered, installed, and configured in accordance with the manufacturer's specifications • Operational qualification (OQ): This validation phase is performed to check that the equipment's performance is consistent with the user requirement specification within the manufacturer- Figure 1: Few processes require validation.