What is ISO 22716, the cosmetic GMP standard?

ISO 22716 sets out GMP for the production, control, storage and shipment of cosmetic products. It does not cover research, development or distribution beyond the manufacturer's gate. The standard is organised into 17 clauses covering personnel, premises, equipment, raw materials, production, finished products, quality control laboratory, treatment of out-of-spec product, waste, subcontracting, deviations, complaints and recalls, change control, internal audit and documentation.

Cleaning and sanitation, equipment maintenance and calibration, batch documentation, sampling and testing, deviation handling, change control, complaints, recalls and self-inspection. The standard does not prescribe the format, but every procedure must be controlled (versioned, approved, accessible) and every batch traceable end-to-end from raw material lot to finished goods.

ISO 22716 is a guideline standard, not a management system standard, so formal certification is optional. Most manufacturers nonetheless pursue certification through a notified body (e.g. SGS, BSI, Bureau Veritas) because it shortcuts customer audits. Brand owners commissioning a manufacturer should request the latest certificate and the most recent unannounced audit report.

ISO 22716 is documentation-heavy. Worldover holds batch records, raw material lots, in-process QC, finished goods release, deviations and change control as structured data, then renders auditor-ready evidence on demand. The standard does not change; the cost of evidencing it does.

ISO 22716 GMP requires documented procedures, batch records and audit trails for every stage of cosmetics production. Meeting this through paper records and spreadsheets works until your first serious audit.

Worldover's MES module produces paperless batch records that meet ISO 22716 requirements by default: digital work instructions, in-process checks, operator sign-offs and automatic audit trail generation. Audit prep takes minutes, not weeks, and per-client batch record formats are generated automatically at close-out.