Pharmaceuticals / Regulatory Affairs / GMPs

Process Validation Should Take Lifecycle Approach, European Commission Says


Drugmakers should clearly define their validation activities in a validation master plan that accounts for the lifecycle of a product and related plant equipment, the European Commission says.

For large and complex drug development projects that require additional planning, it may be helpful to create a separate VMP for each product, the Commission recommends in a draft guideline on Annex 15 — qualifications and validation — of the EU good manufacturing practice guidelines.

The VMP should be a concisely worded summary document and include data on the company’s validation policy; the organizational structure for validation activities; a summary of the facilities, equipment and processes on site; template formats to be used for protocols and reports; processes for handling acceptance criteria; and change control and deviation management processes for validation.

The plan should also confirm that the materials used for validation meet the required quality and that suppliers are appropriately qualified, the guideline says.

The VMP should be supported by an ongoing process verification program conducted under an approved protocol, with separate reports prepared to document any program findings.

Validation protocols should include a brief description of the process, a summary of both the critical process parameters and critical quality attributes, a list of all equipment and facilities, a list of analytical methods and method validation, and a sampling plan and the rationale behind it.

The U.S. Food and Drug Administration also promotes a lifecycle approach to process validation. Validation should begin with the process design stage and continue through commercial production to ensure the process remains in a state of control. The FDA leaves it to industry to cover validation activities as part of an overall project blueprint or to document them individually as a VMP.

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