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ISO 22716 Cosmetics Good Manufacturing Practices (GMP)

We help organizations organize responsibilities, methods and traceable evidence for personnel hygiene, premises and equipment, raw and packaging materials, production controls, storage and dispatch.

We help organizations organize responsibilities, methods and traceable evidence for personnel hygiene, premises and equipment, raw and packaging materials, production controls, storage and dispatch.

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Service classification and standard position

Management system auditing (MS)

ISO 22716 provides GMP guidance for cosmetics production, control, storage and dispatch. It is not a generic management-system requirements standard and does not cover product development or finished-product distribution. Market regulations and certification programs should be confirmed separately.

Official ISO information

Who should consider this and when

Suitable for organizations establishing cosmetics GMP processes, responding to customer requirements or preparing for external review. Confirm the intended use, organizational role, sites and reporting scope before selecting criteria.

Advisory focus

  • Personnel hygiene: assign responsibilities and retain implementation and review records.
  • Premises and equipment: define maintenance, cleanliness and suitability controls.
  • Raw and packaging materials: document receipt, identification, storage and release controls.
  • Production controls: maintain batch records, process controls and deviation handling.
  • Storage and dispatch: preserve product status, conditions and distribution traceability.

Support approach

  1. Confirm scope and criteria: discuss purpose, applicable edition, boundaries and stakeholder requirements; record assumptions and exclusions.
  2. Review current state and gaps: examine records for personnel, facilities, materials, production, storage and dispatch; assign owners to gaps.
  3. Prepare documents and pilot: organize procedures, forms and an evidence index, then test the approach on a real production case.
  4. Simulate review and improve: check data consistency and evidence sufficiency against agreed criteria and track improvements. Confirm any independent third-party body and scope separately.

Information to prepare

  • Organization and site details, product scope and intended use.
  • Personnel, premises, equipment, materials, production, storage and dispatch records and current procedures.
  • Customer, regulatory or program requirements and previous audit or review findings.
  • Responsible departments, available staff, data gaps and target schedule.

Possible deliverables

Depending on scope: a gap list, work procedures, responsibility assignments, record forms, evidence index and improvement tracking. Technical reports and independent review are agreed separately at project start.

Timing and fees

Assessment depends on the number of sites, data quality, product or project complexity and review scope. Existing information is reviewed first, then deliverables, resources and milestones are agreed.

Frequently asked questions

Does advisory support mean a certificate or assurance statement will be issued?

Advisory support helps prepare systems and evidence. Any certificate, verification or validation opinion is decided by a qualified and independent body under the applicable program. This guidance standard does not itself target management-system certification.

Must an existing system be rewritten?

First check whether current procedures and evidence remain applicable. Retain effective practices and revise identified gaps.