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Manufacturing Audits FDA

The USDM team has conducted a variety of audits for the Life Sciences industry. These include vey specific areas that our clients have requested. It takes years of experience and detailed background in order to conduct these audits in a successful manner. USDM has that experience!

Our audit team has years of experience in the most complex formulation and compression mechanisms for tablet compression in addition to other drug profiles.

For example, for solid oral dosage, we provide expert advice for prompt, extended and delayed-release dosages, coated and uncoated products.

For Aseptic Audits, Blow-Fill—Seal and Isolators are extremely technically challenging pieces of machinery which must maintain aseptic conditions. The BFS produces plastic vials from polystyrene resin beads by first melting the beads and extruding a sheet of vials which are filled with product, then flame-sealed, without destroying the product. Isolators are self-contained units which may contain several activities which may result in a several transfers of product, components, closures, etc to produce a final product with minimal human intervention in highly aseptic conditions. USDM has that specific expertise to handle this type of audit.

Other examples of these specific audits include:

    • Facility-Specific Audits : Non-Sterile
      • Dry Powder for Metered Dose Inhaler
      • Parenterals
      • Prompt, Extended, Osmotic-Release (Push/Pull) Products
      • Liquids
    • Facility-Specific Inspections : Sterile Product/Aseptic Fill
      • Isolators Qualification
    • Sterile Facilities – Highly Specialized Services
      • Class 10,000/100,000 Validation, Testing & Certification
      • Aseptic Area Assessment
    • GMP Materials Readiness Audits and Qualification
      • API vendor sourcing: Global supplier audit programs with experience throughout Europe, Asia, Singapore, Japan, India, Latin America/South America
      • Component, Containers and Closure Vendor Assessment
      • Packaging and Labeling System Audit and Assessment
      • Third-party Logistics audit and assessment
      • Warehouse Services Vendor Audit
      • Product Manufacturing, Formulation & Finished Dosage Packaging, Labeling & Distribution
      • Ambient, Controlled Ambient & Cold Chain Product Packaging, Kitting, Storage Distribution
      • Gamma Sterilization Providers
      • Dose Mapping Adequacy Assessment
      • Industrial Sterilizer Quality Assessment

 

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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