What is Process Validation?
Process validation means establishing objective evidence that a process consistently produces a result or product that meet its predetermined specifications.
- Where the 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.
- Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.
It all starts with preparing a validation plan which shall consider the following.
- Elements to be validated.
- Approach to be taken for validation of each element.
- Organizational responsibilities.
- Documentation to be produced.
The content to be covered in the Process Validation protocol shall include the following.
- Identify the process(es) to be validated.
- Identify the device(s) to be manufactured using this process.
- Objective and measurable criteria for successful validation.
- Length and duration of the validation.
- Shifts, operators, and equipment to be used in the process.
- Identify utilities for the process equipment and the quality of the utilities.
- Identify operators and required operator qualifications.
- A complete description of the process.
- Specifications that relate to the product, components, manufacturing materials, etc.
- Any special controls or conditions to be placed on preceding processes during the validation.
- Process parameters to be monitored, and methods for controlling and monitoring.
- Product characteristics to be monitored and method for monitoring.
- Any subjective criteria used to evaluate the product.
- Definition of what constitutes non-conformance for both measurable and subjective criteria.
- Statistical methods for data collection and analysis.
- Consideration of maintenance and repairs of manufacturing equipment.
- Criteria for revalidation.