Microbiological cGMP Requirements for the Non-Sterile and Aseptic Fill ‘n Finish Environment
: 11 Jul 2019
Type: Training, Webinar
As a product proceeds through manufacturing to the API with the addition of various excipients, both non-sterile and sterile products (aseptic fill ‘n finish) must be tested for their microbiological content. With non-sterile products, a limited number of microorganisms are acceptable; with sterile products, no microorganisms may be present.
This two hour live training webinar will provide the learner with an enhanced understanding as well as a “refresher” of what requirements exist for the microbiologist from the end of production through final release for both non-sterile and aseptic produced products. A review of case studies/warning letters pertinant to all phases of the microbiological release will be conducted.