Published on June 9, 2016
1. In 2011, the FDA clarified and consolidated the general principles on process validation. The inseparability of Quality from process validation (PV) has been emphasized in this update. In simple terms, the FDA deems PV to have been met when a product shows performance in the quality of every unit in every batch consistently.
2. Q UA L I T Y, P R O D U C T L I F E C Y C L E A N D C O N T R O L - T H E T R I P O D O F P R O C E S S VA L I DA T I O N Of equal importance as quality is the inextricable link of the product lifecycle to process validation. That is, quality is not something that has to be demonstrated in every unit of every batch of the product for a stipulated period of time; it has to be implemented throughout the lifecycle of the product.
3. In addition, process validation Quality has to be maintained in every unit of every batch of a product throughout its lifecycle while the product is being produced in a state of control throughout the production stages. To make sure this happens, there has to be control at every stage of production. The FDA believes that it is not enough to simply inspect the product during production or after it.
4. Process validation can thus be thought of as being a tripod whose legs consist of three crucial principles -quality, lifecycle approach and control. These are bound to the product and process development of the commercial manufacturing process.
5. P O I N T S TO P O N D E R A B O U T P RO C E S S VA L I DA T I O N With regard to the FDA's thinking relating to PV; the following points need to be borne in mind: According to the FDA, process validation has only a start, and no end, i.e., it stops only when the product's production gets discontinued Knowledge about process validation is gained as the organization gets engaged in commercial production
6. A well designed, thorough and comprehensive process design has to be put in place to get a grasp of the sources of variability and to understand the process Risk management has to be infused into the veins of process validation.
7. PROCESS VALIDATION'S THREE STAGES:
8. THE FDA 'S GENER A L PR INCIPLES ON PROCESS VA LIDA TION SETS OUT THREE STAGES: Process design: The stage which throws up the knowledge needed for process development activities to get expanded into commercial. Process qualification: The stage that confirms the capability of the process design to engage in commercial manufacturing repeatedly and reproducibly
9. Continuous process validation: The stage which confirms the presence of control in the production capability. Maintenance, continuous verification, and process improvement are the ingredients that go into this.