Process validation involves a series of activities taking place over the lifecycle of the product and process.
This guidance outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs or drug substances), collectively referred to in this guidance as drugs or products.
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A successful validation program depends upon information and knowledge from product and process development. This knowledge and understanding is the basis for establishing an approach to control of the manufacturing process that results in products with the desired quality attributes.
The Validation Lifecycle process consists of several different phases, including Requirement Management, Risk Assessment, Test Case Development, Traceability Management, Test Case Execution, Periodic Review and a Change Control Process.
In some organizations, many of these activities are managed within the same department and have generally been managed separately, each with their own procedures and processes. On occasion, they adopt computerized systems for requirements management, test case management and the change control process.