Validating a manufacturing process for a pacemaker
The first step is to clearly define the terms and definitions that will be used during the project.For example, the following terms and definitions might be used. The validation process that starts at the beginning of product design and planning to purchase the production equipment. Validation is based on accumulated historical manufacturing, testing, control, and other data for a product already in production and distribution. This document describes the exact focus of validation efforts and necessary documents. DQ establishes by objective evidence that the equipment specifications conform with user needs and intended use. This process establishes by objective evidence that equipment is constructed and installed according to approved design criteria. OQ establishes by objective evidence the parameters that result in a product that meets all predetermined requirements. This process entails establishing through consideration of objective evidence that the process under anticipated conditions, including worst-case conditions, consistently produces a product that meets all predetermined specifications.
PROCESSES THAT SHOULD BE VALIDATED Device manufacturers must be able to determine which processes should be validated, and what level of evaluation and documentation is required for validation.FDA defines process validation as establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.In plain English, this means that validation is good engineering, with every step fully documented and signed off. Currently, the most important tools for process validation are guidelines.Medical device manufacturers, however, must consider the validation of the manufacturing process.The preparation of necessary validation tests and documentation can be both costly and time consuming if it is performed solely by the manufacturer, prompting some companies to order a qualification package together with the assembly machine.FDA's process validation guidance draft document contains an example of a process validation decision tree that can guide decisions on whether a process needs to be validated or whether the product or process should be redesigned.
This decision tree should only be used to exclude certain parts of the production process from validation after the equipment manufacturer has assessed the risks of the production process for product quality and human safety.
PROCESS VALIDATION OVERVIEW Process validation usually requires six basic steps to completion, including planning, DQ, IQ, OQ, PQ, and review of process and product data (see Table I). PLANNING The first step in qualifying a high-speed assembly machine is to consider the reasons for the process validation, the regulatory requirements, and the available guidelines. This can lead to a faster market launch for new products.
A process can be called validated if the whole procedure, from planning to review of the process and product data, is completed and documented. Increased customer satisfaction, improved product quality, and cost reductions are other common reasons for process validation.
GAMP 3 focuses on computer systems and software validation.
DEFINITIONS OF PROCESS VALIDATION TERMS During the qualification process, it is necessary for everyone to speak the same validation language.
Many small manufacturers are understandably concerned about the costs and resources required to validate a manufacturing process.