Critical Questions and Considerations for Compliance Within the Key Areas of Regulatory Focus
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.
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