RE: Hemogenyx tweet22 Feb 2023 07:43
So a nervous person should research more... One of the last steps in validation process? Training new staff? Hopefully the former.
CONCEPTS, PRINCIPLES AND REGULATORY EXPECTATIONS
NUMBER AND FREQUENCY OF APS
The number and type of APS should be based on Risk Assessment of the aseptic
process.
a. Qualification/validation of a new facility or new production process. APS is
performed after facility, process, equipment, facility decontamination, personnel
training, room qualification and EM program implementation is complete. APS is
one of the last steps in the validation process. Typically a minimum of three (3) APS
are a regulatory expectation.
b. Semi-annual APS are a regulatory expectation for a qualified line/ process.
c. Any major changes to facility or aseptic process – perform Risk Assessment to
determine if APS is needed and how many.