In a recent FDA inspection, a company was cited for failing to utilize actual production personnel to validate a process. Instead, the process engineer at the firm performed the necessary validation steps.
The 483 reads:
“A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
Specifically, SOP…, “Process Validation Procedure,” does not ensure that process validations are adequate. For example,
(b).The process validation does not use production employees, instead was conducted by the process engineer.”
As outlined in CFR section 21CFR § 820.75 b, each manufacturer shall ensure that validated processes are performed by qualified individual(s).
Involving the appropriate personnel, like the production employee in the validation process, ensures the highest standards of quality and safety.
While the process engineer was “qualified” in terms of specific skills and knowledge, this firm missed the critical fact that the actual production would be done by different personnel.
Production personnel may be aware of slight adjustments needed during the process that are not apparent to the engineer. These nuances, if not properly documented and validated, can impact product quality.
Proper validation needs to adhere to user-centered-design concepts, a best practice that emphasizes involving the end-users throughout the entire design and development process.
By including production personnel in the validation process, companies can ensure that the process is designed with their needs, constraints, and real-world scenarios in mind. This approach leads to better validation processes and the safer production of effective products.
With access to GMP Trends, read analysis of FDA 483-Observations and empower employees’ daily work and efforts with actionable information. Schedule a demo of the GMP Trends platform today.
To view more observations pertaining to validation, refer to the following GMP Trends® Issues: 1135, 1130, 1119
Achieve Compliance Confidence with GMP Trends. Schedule a demo today.
