Validating sap

Bio Technique is actively producing drugs to meet the ongoing drug shortages in the American market.

validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes The SAP system setup for Pharmaceutical companies is same as any other industries/organizations; just Pharma companies are regulated by special Government bodies by the state.

Bio Technique, our contract manufacturing facility in Madison, Wisconsin, manufactures sterile injectable products.

Bio Technique provides c GMP compliant contract manufacturing for high value, life-saving therapeutic products.

The PSC Biotech Enterprise Software and IT Business Unit mission is to perform all the necessary activities required to successfully implement an enterprise Gx P IT compliant software application globally across multiple sites and multiple time zones.

Activities PSC Biotech typically performs include: All the software we develop conforms to 21 CFR Part 11 Food and Drug Administration regulations.

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