Sunday, 15 September 2013

Process Validation definitions

Process Validation definitions

According to US FDA  
In 1978 
 “A validation manufacturing process is one which has been proved to do what it purports or is represented to do. The proof of validation is obtained through the collection and evaluation of data, preferably, beginning from the process development phase and continuing the production phase. Validation necessarily includes process qualification (the qualification of materials, equipment, system, building, personnel), but it also includes the control on the entire process for repeated batches or runs”. 

In 1987
“Process validation is establishing documented evidence which provides a high degree of assurance that a specific process (such as the manufacture of pharmaceutical dosage forms) will consistently produce a product meeting its Pre determined specifications and quality characteristics”.

In 2011
“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”.

 According to EMEA

In March 2012
“Process validation can be defined as documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medical product meeting its predetermined specifications and quality attributes.”

Continuous process verification (PCV) has been introduced to cover an alternative approach to process validation based on a continuous monitoring of manufacturing performance. This approach is based on the knowledge from product and process development studies and / or previous  manufacturing experience. CPV may be applicable to both a traditional and enhanced approach to pharmaceutical development. It may use extensive in-line, on-line or at-line monitoring and / or controls to evaluate process performance. Process validation should confirm that the control strategy is sufficient to support the process design and quality of the product. The validation should cover all
manufactured strengths and all manufacturing sites used for production of the marketed product.

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