Definition of process validation
process validation can be defined as scientifically establishing documentary evidence that the process adapted for manufacturing of a drug product or its intermediate is able to consistently produce desired quality of product, the process adapted for evaluation are right from the process design stage till the commercial batch and involves all activities carried out during the products process and its life cycle which include laboratory pilot R&D bathes and commercial scale studies, and all pharma process which will be adapted within commercial manufacturing conditions.
Knowledge of the product and process development is very important for developing a successful validation program. With which one can set desired controls for process which results in desired quality of drug product.
1) A source of variation in a process is very important factor for nonconformance hence the sources of variation must be identified and controls must be established to avoid them.
2) If at all a variation occurs many times the controls might not be able to detect them, hence it is important to detect a small variation in the process. Adapting online computerized process variation monitoring systems are very helpful.
3) The degree of impact of variation on process and product which will be undertaking the process.
4) An appropriate and precise approach to place control for variation starting from source, process
5) A complete control is required to be maintained over the life of the process, material, equipment, and environment , changes in procedures and personnel.
6) One should review the points and stages for opportunities for process improvement.
Pharma Process validation can be subdivided in to three stages as follows.
Stage 1 : Process Design :
A process adapted for manufacturing of a drug product is basically adapted thought the information collected during development of the product in a R & D batches. Based on which its process is designed.
Stage 2 : Process Qualification:
In this stage it is decided that if the under taken process will be able to produce the desired quality of drug product and is capable of reproduce the same results whenever the process is adapted for manufacturing. The process developed during design is qualified for its adaptation a process for manufacturing a drug product.
Stage 3 : Continued Process Verification
Why process validation:
A drug or drug product is considered adulterated if the facility, process, methods, or controls used for manufacturing of drug product do not meet the requirements of current good manufacturing practices. Which states the process adapted must be validated?
Details of which are given in Current good manufacturing practice (CGMP) for finished
Pharmaceuticals in 21 CFR parts 210 and 211.under sections 501(a)(2)(B) of the Act (21 U.S.C. 351(a)(2)(B)) it is a legal requirement.
In Pharma Process validation is directly related to quality of product.
A process which is effectively validated assures a better quality of drug being manufactured.
Quality of a drug product can’t be assured just by in process quality control checks, but it can be build by adapting a sound validated and effective process which will help in manufacturing of a drug which is qualifies to its predetermined quality, safety, and efficacy.
That means a process which is validated that it is effective to produce a drug of desired quality, is most sought after.
By validating manufacturing process we can assure that each step in manufacturing process is controlled to produce the desired quality of drug.
Quality of drug means the level or standard set up for a drug product to which it has to comply so that its safety and efficacy is established.
Process validation activities with a product life-cycle concept:
This concept adheres to development of product and all the processes associated with its development, qualification of products development stages till commercial manufacturing.
This article is written in accordance with guidelines for process validation in pharma industry for drugs used on human, drugs used for treating animals which may include drugs obtained from biotechnology and biological origin. And all finished products and active pharmaceutical ingredients, and a drug carrying medical device (combination drugs), inconsideration with validation of automated process control systems.
Following topics are not covered here. Which will be covered in next article.
process validation related to medical devices , medicated feeds, dietary supplements , human tissues for transplantation, and validation of automated process control systems.
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