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GMP Compliance

Perhaps the most critical element in which validation and compliance standards are applied is GMP. Many of USDM auditors have experience and background in manufacturing and the associated regulations pertaining to this area.

For example, equipment in an API manufacturing facility must be qualified in such a way that assures repeatable quality product. Resin used in more complex “rolling beds” for example can be contaminated quickly as well as the filters. USDM has experience in a wide variety of API equipment and can provide assurance through the most rigorous audit.

Other areas of GMP audits include:

  • Active Pharmaceutical Ingredient (API) Manufacturing to ICH Q7A
  • IOP Qualification (Instrumentation, Manufacturing, Laboratory)
  • Chromatography Resin, Virus removal, and Pharmaceutical Grade Sterilizing Filter

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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