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Process Validation

There are three types of Process Validation

  • Prospective Validation: This should be completed prior to the distribution and sale of the medicinal product.
  • Concurrent Validation: This may be carried out in exceptional circumstances where it is not possible to carry out prospective validation. For this we would validate the process during routine production.
  • Retrospective Validation: Processes which have been in use for some time also need to be kept in check to make sure they still operate in a valid manner. This is not applicable to process where recent changes e.g. composition of the product, equipment have been made.

Cleaning Validation is another prime GMP requirement. Kennet Bioservices Ltd has assisted a number of clients with GMP compliant cleaning validation studies.
 
All the above involve inspections of the staff, facilities, systems and equipment involved in the process.  For an example of our work click here .