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What forms cGMP?

Published in Regulatory Compliance 1 min read

Based on the provided reference, the question is incomplete. The reference describes cGMP as a set of regulations, not a substance that is formed. A more appropriate question would be: "What does cGMP refer to?".

cGMP refers to the set of regulations established by the United States Food and Drug Administration (FDA). These regulations contain minimum requirements for the methods, facilities, and controls used in the manufacturing, processing, and packing of a product.

In essence, cGMP ensures:

  • Quality Control: Establishes guidelines to minimize risks like contamination, deviations, and failures.
  • Consistency: Ensures that products are manufactured consistently and meet quality standards every time.
  • Patient Safety: Protects patients from harmful or ineffective products.
  • Regulatory Compliance: Helps manufacturers comply with FDA regulations.