Information & Training. | Product & Process Validation.
Why Validate a Process?Validation is the process of gathering and analyzing data to confirm that a product or process will consistently perform as expected.
“Process Validation” is performed to confirm that a process will consistently operate as intended.
“Product Validation” will confirm that the product can repeatedly perform as designed.
When products and processes are effectively validated, there will be a high level of confidence in the ongoing quality, reliability, safety and efficacy of the outputs of a process, i.e. the final product or service. Where an effective validation program is not implemented, unexpected quality, reliability, safety or efficacy outcomes can arise which may result in process shut-downs, product recalls, regulatory sanctions, litigation, etc..
Validation seeks to minimize the potential for process or product non-conformance to design and development intent.
What is Process Validation.Process Validation is the recording and analysis of data from a process, and utilizing the data to confirm that the process is capable of consistently operating within defined specifications.
What is Product Validation.Product Validation is the recording and analyzing of data from a product, and utilizing the data to confirm that the product is capable of consistently meeting design and customer requirements.
What is Validation.As a product and process are effectively linked, i.e. the product is the output of the process, “validation” becomes a generic term incorporating both process and product:
Validation is the recording and utilization of data, to confirm that a product, process, service, system can consistency meet design specifications and customer requirements.
In many industries best Validation practice is a regulatory requirement.
Per the U.S. FDA, QSR’s
FDA 21 CFR 820.30(g) Design validation. (Devices)
Each manufacturer shall establish and maintain procedures for validating the device design.
Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents.
Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions.
Design validation shall include software validation and risk analysis, where appropriate.
The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the Design History File.
Per the US FDA 21 CFR 820.75 Production and Process Controls – Process Validation
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. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented.
(b) 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.
(1) Each manufacturer shall ensure that validated processes are performed by qualified individual(s).
(2) For validated processes, the monitoring and control methods and data, the date performed, and, where appropriate, the individual(s) performing the process or the major equipment used shall be documented.
(c) When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate. These activities shall be documented.
Information & Training.
Product and Process Validation.
- The Validation Master Plan. Performing a Gap Analysis. Validation in the Design Process. Etc..
- Current Validation practice. How to ensure Validation efforts are aligned with potential Risks.
- How to ensure that Validation activity is appropriately documented, reviewed and aligned with requirements.
- Information & Training presentation >>>