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Factory Qualifications

Good Manufacturing Practice (GMP)

Definition

Good Manufacturing Practice (GMP) is a set of principles and management systems designed to ensure that products are consistently manufactured and controlled to quality standards appropriate to their intended use. WHO regards GMP as an important part of quality assurance. Its core purpose is to systematically manage personnel, premises, materials, production processes, quality control and documentation to reduce manufacturing risks that cannot be fully eliminated through final product testing alone.[1]

GMP is not a single, globally uniform standard or certification. Different product categories, countries and regions may implement GMP principles through regulations, international standards or guidance issued by regulatory authorities.

For example, ISO 13485 is widely used as an internationally recognized quality management system standard for medical devices;[2] ISO 22716 is widely used as international GMP guidance for the production, control, storage and shipment of cosmetics.[3] Countries and regions may also issue their own GMP regulations or guidance, such as the U.S. FDA's Cosmetic GMP Guidance.

Why does it matter?

For regulated products such as medical devices and cosmetics, target markets typically impose requirements on manufacturers' quality management systems or GMP practices. International standards such as ISO 13485 and ISO 22716 are therefore frequently used for regulatory compliance, customer audits, tenders and supplier qualification.

A legal requirement to comply with a quality system or GMP requirements does not always mean that holding a particular third-party ISO certificate is legally mandatory. The specific requirements depend on the product category and target market.

Even where local regulations do not prescribe a particular GMP certification, an independent third-party GMP audit or certification can be an effective supplier screening tool. It helps buyers assess whether a manufacturer has established systematic controls for premises hygiene, personnel, production, quality control, documentation and traceability.

References

  1. [1]World Health Organization (WHO), Good Manufacturing Practices.
  2. [2]International Organization for Standardization (ISO), ISO 13485:2016 — Medical devices — Quality management systems — Requirements for regulatory purposes.
  3. [3]International Organization for Standardization (ISO), ISO 22716:2007 — Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices.

Other Glossary Terms

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  • Good Manufacturing Practice (GMP)

    Good Manufacturing Practice (GMP) is a set of principles and management systems designed to ensure that products are consistently manufactured and controlled to quality standards appropriate to their intended use. WHO regards GMP as an important part of quality assurance. Its core purpose is to systematically manage personnel, premises, materials, production processes, quality control and documentation to reduce manufacturing risks that cannot be fully eliminated through final product testing alone.

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  • ISO 13485

    ISO 13485 is an international quality management system standard specifically developed for the medical device industry. It specifies requirements for a quality management system that enables organizations to consistently meet customer requirements and applicable medical device regulatory requirements.

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  • ISO 14001

    ISO 14001 is an internationally recognized environmental management system (EMS) standard. It provides a framework for establishing, implementing and continually improving an environmental management system, enabling organizations to systematically manage their environmental impacts, applicable regulatory obligations and environmental objectives.

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  • ISO 22716

    ISO 22716 is international GMP guidance developed for the cosmetics industry. Its official scope covers the production, control, storage and shipment of cosmetic products.

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  • ISO 45001

    ISO 45001 is an international standard for occupational health and safety (OH&S) management systems. It specifies management system requirements for managing occupational health and safety risks and improving OH&S performance.

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  • ISO 9001

    ISO 9001 — Quality management systems — Requirements is an internationally used quality management system (QMS) standard. It specifies requirements for establishing, implementing, maintaining and continually improving a quality management system to help organizations consistently meet customer requirements and improve quality management performance.

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  • SMETA 4-Pillar Audit

    SMETA is an on-site social audit methodology developed by Sedex. It uses a standardized approach to assess working conditions and responsible business practices at supply chain workplaces.

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  • U.S. FDA Cosmetic GMP

    The U.S. FDA publishes Cosmetic GMP Guidelines/Inspection Checklist to guide and inspect cosmetic manufacturers' production and quality management practices concerning premises, personnel, equipment, raw materials, production, laboratory controls and records. FDA states that strict adherence to GMP helps reduce the risk of adulteration or misbranding of cosmetics.

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