Process Validation Case Study

VALIDATION
USFDA defines validation as: “Validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics. According to European commission: Validation is defined as “Action providing in accordance with the principles of GMP, that any procedure, process, equipment, material, activity or system actually lead to the expected results.(1)
In Pharma Industry it is very important apart from final testing and compliance of product with standard that the process adapted to produce itself must assure that process will consistently produce the expected

These can be developed from the knowledge of the process and facilities, systems or equipment.
• Tests to include conditions with upper and lower limits
Process Validation: -
Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products. Process validation is a requirement of current Good Manufacturing Practices (GMPs) for finished pharmaceuticals (21CFR 211) and of the GMP regulations for medical devices (21 CFR 820) and therefore applies to the manufacture of both drug products and medical devices. Process validation involves a series of activities taking place over the lifecycle of the product and process. (8)
• The FDA guidance describes process validation activities in three stages.
• Stage 1 – Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.
• Stage 2 – Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial

Prospective Validation: It is establishment of documented evidence of what a system does or what it purports to do based upon a plan. This validation is conducted prior to the distribution of new product.
2. Retrospective Validation: It is the establishment of documented evidence of what a system does or what it purports to do based upon the review and analysis of the existing information. This is conducted in a product already distributed based on accumulated data of production, testing and control.
3. Concurrent Validation: It is establishment of documented evidence of what a system does or what it purports to do information generated during implemented of the system.
4. Revalidation: Whenever there are changes in packaging, formulation, equipment or processes which could have impact on product effectiveness or product characteristics, there should be revalidation of the validated process.
Conditions that require revalidation studies are:
• Changes in critical component
• Change in facility or