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Foxwyn Global Assurance LLP

Product Certification

GMP — GMP — Good Manufacturing Practices

Gap assessment, documentation and readiness support for GMP requirements across pharmaceuticals, cosmetics, nutraceuticals and food.

Enquire about GMP
GMPProduct Certification

What it addresses

GMP establishes controls over premises, equipment, personnel, hygiene, documentation and batch processes so products are consistently produced to quality standards.

Who it is relevant to

  • Pharmaceutical and nutraceutical manufacturers
  • Cosmetics manufacturers (including ISO 22716)
  • Food and supplement producers
  • Contract manufacturers and exporters

Typical consulting scope

  • Applicable GMP framework identification (Schedule M, WHO-GMP, ISO 22716, etc.)
  • Facility, hygiene and process gap assessment
  • SOPs, batch records and validation documentation
  • Personnel hygiene and GMP training
  • Mock audit and corrective-action support
  • Readiness for inspection or certification audit

Documents and inputs required

  • Facility layout and product list
  • Manufacturing process flow
  • Existing SOPs and batch records
  • Equipment and cleaning records
  • Regulatory licences held

Implementation stages

  1. 01

    Framework and scope confirmation

  2. 02

    Site gap assessment

  3. 03

    Documentation and system development

  4. 04

    Training and implementation

  5. 05

    Mock audit and readiness review

GMP certificates or compliance are determined by the applicable regulator or certification body. Foxwyn provides consultancy and application support only.

Part of Product Certification & Market Access.

Let’s turn your requirements into a clear action plan.

Tell us about your organisation, product or project. Our team will help define the scope, documentation needs and next steps.

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