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Regulatory

GMP

Definition

Good manufacturing practice: quality controls for consistently making and testing products to appropriate standards. In US drug regulation, CGMP means current good manufacturing practice.

By PurePeptideHub Editorial Team · Updated . Educational source review; independent clinical review pending.

Quality is a system

FDA describes CGMP as controls over manufacturing processes and facilities, including materials, procedures, testing and investigation of failures. An end-product purity result is one piece of information. It does not describe every control needed to prevent contamination, mix-ups or incorrect strength.

References: [1]

How to assess a GMP claim

When a supplier displays a GMP badge, ask which facility, process, product category and certifying or inspecting body it refers to. Check the document’s scope and date. A statement about a raw-material factory is not automatically a statement about a finished product or its packaging.

What GMP does not prove

Manufacturing quality and clinical efficacy are separate questions. A credible quality system does not demonstrate that a compound treats a condition. Likewise, a certificate of analysis for one batch cannot establish approval of a medicine. Keep those questions separate when reading a supplier page.

Sources and further reading

  1. FDA: Facts about current good manufacturing practice

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