GMP Auditing

UL helps manufacturers, packagers and distribution centers demonstrate conformance to ISO international standards, the Code of Federal Regulations (CFR) and regional requirements through GMP certification, and GMP audit services.

They offer facility and supply chain audits and certifications that promote conformance to the United States Food and Drug Administration (FDA) Good Manufacturing Practices requirements relating to:

  • cGMP OTC Drugs
  • cGMP OTC Drugs API/Excipient/Component
  • cGMP Dietary Supplements
  • cGMP Dietary Ingredients
  • cGMP Medical Devices
  • cGMP Cosmetics
  • ISO 22716:2007
  • cGMP Food
  • cGMP Infant Formula
  • General Consumer Products GMP

Using our unique six-system approach to quality management, UL helps evaluate if an FDA-registered factory’s quality system meets or exceeds defined current GMP.

These services help mitigate supply chain risk, protect brand value and promote consistency by verifying product quality and quality management systems at the factory level.

Globally, UL is ACLASS/ANAB Accredited by the ANSI-ASQ National Accreditation Board to provide the ACLASS/ANAB Symbol for a variety of GMP schemes, which highlights UL’s technical competence as a certification body. UL’s ACLASS/ANAB Accreditation means the UL methods and procedures used in the Retail Certification Program and National Brand Certification Brand Program are approved and evaluated by a third-party. This oversight helps provide increased confidence to the client, supplier, or customer.

These GMP audits can help satisfy multiple retailer or brand requirements simultaneously, helping to reduce audit fatigue, cost and redundancy while also meeting key requirements.


UL and The Natural Products Association (NPA) Good Manufacturing Practices (GMP) Dietary Supplements Program

UL has partnered with The Natural Products Association (NPA), the nation’s largest trade organization representing natural products, to create a Good Manufacturing Practices (GMP) Certification Program. The new UL and NPA certification helps to ensure quality and safety in the dietary supplements industry, while aiming to reduce risk and increase consumer and retailer confidence as well.

Upon successful completion of the UL and NPA GMP Dietary Supplements Certification Audit, a customer will have access to a co-branded, dietary supplement-specific mark program for use in product labeling, marketing materials, websites and social media. The use of both the NPA and UL marks in its co-branded partnership will only be available for companies certified under the NPA GMP standard with audits conducted by UL.

 

In alliance with

UL