The regularity of your validation schedule may vary, depending on the risk and criticality of the equipment being validated. Having validated thousands of chambers, autoclaves, reactors, ovens, centrifuges, and other bioprocessing equipment, we have seen four general trends of validation schedules:
- qualification upon installation, without re-qualification
- qualification upon installation, with qualification only if a component was changed or the unit was moved
- qualification upon installation, with re-qualification every three (3) years
- qualification upon installation, with annual re-qualification
In general, the more critical the piece of equipment, the more frequently it is re-qualified.
Increasingly, companies are adopting the ASTM E2500Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment, which describes a science- and risk-based approach to commissioning and qualification. Compared against traditional IQ / OQ / PQ approaches, the ASTM approach is based on risk management practices, subject matter expert knowledge, good engineering practices, and vendor / manufacturer involvement to ensure that the qualification process is appropriate for the level of acceptable product risk. Implemented correctly, the E2500 standard could potentially save time and money without respective degradation in the efficacy of the qualification.
You alone can determine the correct validation approach and schedule for each particular piece of equipment in your production chain. You know which stages of product development require specific tolerances, and which pieces of equipment in your line are the most critical for ensuring adherence to your SOPs. (E.g. a sterilizer may require annual re-qualification; a chamber may be able to be validated less frequently.). Thorough discussions with your leadership, engineering, laboratory, facility, and quality professionals can help you come to the right solution.
Regardless of your approach to ongoing validation, it is critical to document your approach and then rigorously follow it. The focus of most audits is not whether or not the auditor agrees with the documented process; but rather, did you deviate from following your own documented processes. Make a procedure, and then follow it.
With experience in qualifying thousands of individual pieces of equipment, of all types and manufacturers, in cGMP facilities large and small, Masy BioServices can consult with you on the best approach to validating your bioprocessing equipment and environmental chambers. We are well-versed with both traditional IQ / OQ / PQ methodology as well as the ASTM E2500 risk-based standard; our validation professionals can create SOPs compliant to either approach, and then execute your SOPs quickly without sacrificing quality or accuracy. Contact Masy today to learn how we can help you develop — and execute — the right validation approach for your business.