Validation of biotechnology products and processes.
Recent advances in the validation of biotechnology products have focused on clearer definitions of the requirements for cleaning validation, especially for multi-product facilities. In addition, sensitive analytical methods have been developed that can be validated. This, together with computer validation, has contributed to the biotechnology industry's ability to demonstrate the production of safe and efficacious products for biotherapeutic and diagnostic purposes.
Sofer
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Pharmacia Biotech, Piscataway, USA.
D000818:Animals; D001709:Biotechnology / Q000379:methods* / Q000592:standards*; D005069:Evaluation Studies as Topic; D006801:Humans