Laboratórios ADPEN tem um forte compromisso para proteger o nosso ambiente e a saúde pública. Trabalhamos diligentemente com a indústria de agroquímicos em seu esforço para garantir a conformidade do … Learn More!
FDA’s 2011 Process Validation: General Principles and Practices guidance created a systemic shift in industry’s approaches to validation programs. The authors describe the three-stage approach to validation that is outlined in the new guidance and discuss questions surrounding implementation. In January 2011, FDA published its long-awaited guidance for industry on Process Validation: General Principles and […]
The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), issued its support for the introduction of a House bill, the Generic Drug and Biosimilar User Fee Act (HR 3988), which SOCMA says will help to achieve parity between foreign and domestic firms. In its statement, SOCMA said […]
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