Manufacturing Audits

Overview

UL manufacturing audits help to mitigate supply chain risk, to protect brand reputation and to promote consistency through verifying quality management systems at the factory level.

Definition

UL manufacturing audits are designed to pinpoint inconsistencies, weaknesses and risks at the factory level.

Current Good Manufacturing Practices (cGMP)
Using UL’s approach to quality management, our manufacturing audits help evaluate if a U.S. Food and Drug Administration (FDA) registered factory’s quality system and operation meets or exceeds defined current good manufacturing practices (cGMP) requirements. UL audit services help a manufacturer, packager or distribution center demonstrate compliance to international standards, focusing on the FDA good manufacturing practices (GMP).

UL management systems offers facility and supply chain audits that promote conformance to the U.S. FDA GMP 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

If an organization decides to take an audit to the next level and gain a certification, UL Management Systems Registrar LLC is an accredited certifying body.

Benefits

Our qualified auditors have extensive knowledge of regulatory standards; UL can help a customer implement manufacturing best practices.

As an independent management systems expert, UL supports brands and manufacturers in the development and production of consistently safe products to quality levels demanded by customers, consumers and regulatory bodies.

With extensive technical capabilities and industry expertise, we are able to pinpoint inconsistencies, weaknesses and risks at the factory level. Our global team of qualified auditors and inspectors provide actionable insights that help enable brand managers, compliance officers and quality assurance specialists to make informed decisions directly impacting brand credibility and product marketability.

Our management system services are designed to help customers ensure the quality, safety and adequacy of systems in operation at a manufacturing or packaging plant, distribution center, or warehousing operation. 


DELIVERABLES

CAPA approval process


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