The Validation Protocol

A written validation protocol should be established that specifies how process validation will be conducted. The protocol should be reviewed and approved by the quality control unit and other designated organizational units.

The validation protocol should include the following: - Purpose and scope of the validation; - Functions and responsibilities of all organizational units involved in the validation; - Type of validation to be conducted with appropriate justification for type chosen; - Number of process validation runs; - Quality of materials used in the process (e.g., recovered vs. fresh solvents); - Description of the process (e.g., discussion of the chemistry, unit operations, process flow diagram); - All major process equipment used, its type/design, and its installation and operational qualification (IQ/OQ); - The critical quality attributes of the API; - The critical process parameters and operating ranges; - Sampling plans (i.e., sampling points, frequency, quantities, and procedures for collecting samples); - Specifications and test data to be collected; - Acceptance criteria needed to conclude that the validation has been successful; and - Steps to follow in the event of a process validation failure.

The above information need not be incorporated in the validation protocol if the protocol makes specific reference to other documents that contain the information (e.g., COA’s, development reports, and IQ/OQ reports). Any changes to the validation plan should be documented with appropriate justification.