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For many startup medical device companies, as well as for pharmaceutical companies developing drug-delivery devices, taking on the unfamiliar device manufacturing process can be intimidating. The assembly validation process often takes 13 to 16 months to complete for large-scale systems and is complicated by a variety of regulatory hurdles. With a robust validation system and detailed product specifications, the assembly validation process can be achieved quickly and efficiently. By understanding the elements that feed the validation processes, pharmaceutical and device companies can anticipate issues and plan for device production that meets regulatory demands, performs to high-quality standards, and moves product into commercial quantities while maintaining a high degree of reliability.

Assembly validation done right

Validation is required by ISO 13485 and the medical device good manufacturing process regulations, 21 CFR Part 820—specifically, Sections 820.30(g) Design Validation and 820.75 (a) Process Validation. Process validation, in short, is defined as:

ISO 13485, section 7.5.2.1: The organization shall validate any process for production and service provision where the resulting output cannot be verified by subsequent monitoring and measurement.

21 CFR 820.30 (g): Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF.

21 CFR 820.75 (a): Wherethe results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented.

When process results cannot be 100 percent verified by inspection and test, the process must be validated to a high degree of assurance in meeting specifications, processes, and procedures. The validation process is then subject to audit processes via statutory inspections to determine compliance to applicable regulations. This means that validation is an essential step in controlling specifications for the device manufacturing process to help ensure that the device not only functions well when it reaches the patient, but also can be reproduced through a consistent process with a high level of accuracy and repeatable, high-quality results.

Developing a robust assembly validation program, Fig. 1

So how does a company get those results? It is essential for a manufacturer to evaluate all factors that affect product quality—including automation equipment and product designs—when constructing and undertaking a process validation phase or process study. The validity of acceptance specifications should be verified through testing and challenge of the product on a sound scientific basis during the initial development and pre-production phase. Finally, once a specification is demonstrated as acceptable, it is important that any changes to the specification be made in accordance with documented change control procedures (Figs. 1-2).

By partnering with an experienced contract manufacturer that not only understands each of these steps but also the nuances that accompany each validation phase and specification change request, pharmaceutical and device companies can be sure that the validation process will be done right. Contract manufacturers should insist upon identifying the scope of the project up front and spending time to ensure that the project specifications and proposal requests for machinery builds are as robust and detailed as possible. This will help save time and money further down the line.

Developing a robust assembly validation program, Fig. 2

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