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This blog mainly talks about QMS,cGMP,Regulatory Filings & Guidelines,Validation & Qualifications,Drug Stability,FDA 483s &Media Fill.
Hope this blog will cater the needs of both fresher’s and experienced professionals.
Sunday, 15 September 2013
Process Validation definitions
According to US FDA
“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”.
“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”.
“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
“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.