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In late April, EMA cleared its final guideline on what to submit in marketing applications regarding process validation for drugs that have active substances derived using biotechnology. Specific points of consideration covered are: ● the evaluation and veri- fication of the upstream process ● general issues related to single use equipment and multiple harvests ● the evaluation and ver- ification of the downstream process ● reprocessing ● hold time, storage, and transportation, and ● multi-facility production. The guideline was released in draft form for comment in 2014. [See IPQ February 12, 2013 for an in-depth review of the development of the guideline and its relationship to EMA’s PV GMP efforts.]
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
