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The Complete Guide to Supplier Qualification & Quality Management

A Risk-Based Approach to Qualifying, Managing and Auditing Third Party Providers

The U.S. FDA and other regulating bodies are increasingly inspecting and citing manufacturers of nonprescription drug and health products for current Good Manufacturing Practice (CGMP) violations.

Many of these deficiencies underscore widespread underlying inadequacies in implementing and maintaining a robust Quality Management System (QMS).

This guide offers manufacturers of OTC and similar health products actionable summaries and expert analyses of common CGMP compliance and QMS problems along with key questions for assessing compliance accordingly.

What you'll find inside:

  • A summary of key regulatory requirements for supplier management
  • A step-by-step guide to qualifying suppliers, vendors & other contractors
  • The formula for crafting an effective quality agreement
  • The blueprint for adopting a risk-based approach supplier quality management
  • Tips for working with third party professionals when planning and running supplier audits
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