Process validation is characterized by the collection and evaluation of information, from the planning stage of the procedure to its creation. Furthermore, this generates experimental confirmation that the end result of the procedure is fully capable of delivering a quality finite product to consumers.
Today, process validation is known to be a strict requirement of the Good Manufacturing Practices (GMP) for whole drug products and the GMP regulations for restorative medical devices. Subsequently, the validation of the process is applied to the production of drugs and medicines and also to the manufacture of medical devices.
The drug validation process includes a progression of activities that occur throughout the process of creating a specific product.
Process validation protocol for pharmaceutical products
A detailed process validation protocol is vital to ensure that the procedure is approved accordingly. All successful process validation protocols should include the following components:
• The objectives and final scope of the study.
• You must name all the members of the validation team and also their qualifications and responsibilities.
• The protocol must mention the type of validation, such as prospective, concurrent, retrospective and revalidation stages.
• The protocol must include a detailed list of all equipment to be used and normal operating parameters.
• All requirements for calibration of all measuring devices used.
• Probable risks and prevention.
• Detailed description of the steps of the process steps
• Sampling points, methods and sampling plans.
• Statistical tools for data analysis.
• Validated test methods for the finished product.
• All forms to document results.
• Documentation of conclusions and final approval of results.
Together with these elements that make up the process validation protocol, its definition is actually broader and more complete.
Therefore, the definition of the process validation protocol for pharmaceuticals is really made up of a written plan that includes everything from how the process will be carried out, who will carry it out, what the parameters are, sampling plans and the methods to be used. Also, you should always include the equipment used. In addition, there is a specific number of lots approved for the study, specific criteria that must be met and also who will give the final result of the process and product.
For the situation where a protocol is adjusted or altered after its approval, the appropriate thought for such change should be recorded.
Likewise, all the people included in the direction of the studies must be adequately prepared and qualified as they can crucially affect the nature of the product.
They can have a great impact on the final product due to the fact that all the data resulting from the study will be evaluated by these qualified people against all the criteria and will be considered as meeting or not.
If such an assessment appears, to the extent that the protocol criteria have not been met, the study should be considered to have failed to show acceptability and justifications should be explored and archived.
Finally, any failure to follow the protocol should be considered compromising and requires a basic assessment of the full effect on the study.
The last confirmation of the validation process must indicate the predetermined recognition criteria against which the final results of success or failure were evaluated.
conclusion
Finally, it can be concluded that the process validation protocol for pharmaceutical products is a fundamental orientation plan for achieving drug quality objectives. Detailed criteria and studies aim to bring quality products to consumers around the world.
