Validation protocols

In cGMP environment all procedures, processes, equipments, analytical methods have to be validated.

Validation documents effectiveness and reproducibility of a process.

Validation protocols must be written in advance and approved by relevant Quality Units, in there acceptance criteria should be specified.

At the end of the Validation Process a Validation Report has to be written summarizing results obtained, any deviation encountered and drawn conclusions.

Validation approaches can be: prospective, concurrent and retrospective.

For prospective and concurrent validation three consecutive runs are suggested.

Prospective Validation should be the one of choice.

Validated systems should be periodically reviewed and re-validated.

For analytical methods validation, ICHQ2 guide-lines must be followed.

According to ICHQ2 different kinds of analytical procedures can be validated: identity tests, impurity tests (quantitative and limit), potency test.

In ICHQ2 different characteristics for validation are listed: pending on the kind of test, criteria for precision, Repeatability, Specificity, Detection Limit, Quantitation Limit, Linearity and Range need to be verified during the Validation process.

Procelltech provides Quality Control Assays validated according to principles of ICHQ2.

Also it provides consultancy services for validation approach to be established in a cGMP site, including drafting of pertinent documentation (Validation Master Plan, Validation Protocols and Validation Reports).