Process validation is reliant upon a detailed review of the design of the product.

The purpose of this review is to identify the critical process parameters, and then determine the most appropriate controls and process specifications, for each stage of the production process.

Design Controls

Design controls are quality practices that act as a system of checks and balances incorporated into the design and development process, which systematically assess of the design of a process as an integral part of its development.

This allows any deficiencies in the proposed process which may result in discrepancies between the product produced by the proposed processes and product requirements, to be identified and corrected at an early stage in the development process.

Therefore, design controls increase the likelihood that, when transferred to production, the process will produce a product that is suitable for its intended use. Design controls also provide improved visibility of the design process. This allows more effective control of the design process, recognize problems earlier and make corrections.

21 CFR Part 820.30

These can sometimes be derived from the design output for each product or process that needs to be validated. Processes are developed according to design controls in 21 CFR 820.30 and the process specifications (parameters) are derived from the specifications for the device.

These parameters must be documented in the device master record per 820.30, 820.40, and 820.181. Thus, 21 CFR 820 regulation is highly relevant to process validation and must be completed prior to process validation.