Pharmaceutical process validation protocol template

Your sampling plan should specify sampling points throughout the process, number of samples per batch, frequency of sampling, and statistical justification for sample sizes. Include both in-process and finished product sampling, ensuring representation of beginning, middle, and end of production runs. Remember to document your rationale for the chosen sampling strategy based on product risk assessment.

While the FDA doesn’t specify an exact number, three consecutive successful validation batches are traditionally considered the industry standard for initial process validation. However, the appropriate number depends on process complexity, risk assessment, and prior knowledge. Some high-risk processes may require additional batches, while well-understood processes with robust historical data might require fewer.

Revalidation is necessary after significant changes to equipment, raw material suppliers, manufacturing location, batch size, or critical process parameters. Also consider revalidation when trend analysis from continued process verification indicates drift in process performance, after multiple deviations, or when product fails to meet specifications. Establish clear revalidation triggers in your validation maintenance program.

Supporting documentation should include development reports, risk assessments, equipment qualification documents, analytical method validation reports, and material specifications. Also include relevant standard operating procedures, training records for personnel involved, and previous validation studies if applicable. This documentation creates a complete knowledge package that demonstrates the scientific rationale behind your validation approach.