Medical Device Validation Process | Equipment Validation

1. Medical Device Validation Process https://www.operonstrategist.com/medical-device-process-validation/

2. Process Validation • Validation is a process of establishing documentary evidence demonstrating that a procedure, process or activity carried out in production maintains the desired level of compliance at all stages.

3. We assists for the following validation: • Equipment Validation • Process Validation • Facilities Validation • Utility Validation • Microbial Validation • Software Validation • Packaging Validation Validation

4. Medical Device Validation Process • In simple words, the process validation is the collection and evaluation of data, from the process design stage till the production, as it gives scientific evidence that the process is capable of consistently providing quality products. • Medical Device Process Validation is an important cGMP requirement & many regulatory agencies audit the validation documentation. • Validation of a machine or a process is carried out to ensure that products of consistent quality are manufactured and the required level of compliance is met at every stage. Since a wide variety of procedures, processes & activities need to be validated.

5. Validation Process: Change Control Re-validation

6. Decision tree for process validation • The Following decision model can be used to determine whether the process is critical or not, based on the risk that products will be released, which are not within the predetermined specifications. Is Process output verifiable with specification Is verification sufficient and cost effective? yes Verify and control the process yes Quality critical process no no Process Validation Fig. : Decision tree for process validation / quality critical process

7. Documentation for Validation • At the beginning validation release all documents should be approved and reviewed. • The quality unit should be responsible for any release decisions • Version control should track document revision.

8. Plan Approval Protocol 1 Protocol 2 Protocol 3 l Approval Approval Approval Testing Testing Testing Report 3 Report 1 Report 2 Approval and Release Approval and Release Approval and Release Fig.: Example of documentation structure Small Project Validation Summary Report Large Project Approval and Closure

9. Being a medical device consultant, Operon Strategist provides medical device process validation training to manufacturers & medical device process validation service providers for the validation activity & documentation. The product and the production facility are studied to document the validation master plan according to which validation activities will be performed as per the defined timeline. • We also guide manufacturers & medical device process validation service providers on the validation activity & documentation. We provide guidance for preparing medical device process validation protocols & reports in the correct format so as to meet the regulatory requirementsincluding IQ OQ PQ DQ protocols & PQ report.

10. Thank You. For More Information Contact Us www.operonstrategist.com info@operonstrategist.com +91-9325283428 |+91-9165020618