ISO 22716 and cosmetic GMP: a practical orientation

Separate the manufacturing duty, the standard and the certificate

These are three different questions. Which manufacturing requirements apply to the product and market? Which standard or other basis is being used to demonstrate the approach? What does any certificate actually cover? Answering one does not automatically answer the others.

The HPRA cosmetics guidance directory links to guide IA-G0048-3, dated 11 February 2026. It addresses cosmetic GMP and supplements the standard. The GB official guidance separately describes manufacturing duties and the role of ISO 22716. Use the appropriate market source and current legal provisions; this orientation does not assess a manufacturer's system.

Identify what was consulted

ISO's public record for ISO 22716:2007 identifies the edition and gives its public scope: production, control, storage and shipment of cosmetic products. The catalogue description is not the complete standard. Record the exact edition, access route and sections actually consulted before using it to support a detailed review.

The source consultation recorded for this guide covers the public ISO catalogue and abstract. It does not include the complete licensed standard. No clauses are reproduced or reconstructed. This guide explains how to prepare a standards/protocol review; it does not provide a clause-by-clause GMP assessment.

The consultation worksheet keeps those limits visible. Do not mark a standard fully reviewed because someone has downloaded its title page or read a summary. A specialist protocol also needs an identifiable version and a documented relationship to the task; its name alone does not establish its adequacy.

Inspect a certificate as a separate record

ISO explains that it develops standards and does not perform certification or issue certificates. If a manufacturer supplies a certificate, record the actual issuing body, named organisation, site, scope, standard edition and dates. Verify the record through the appropriate issuer route and keep the outcome.

A certificate referring to one site or activity should not silently become evidence for every product, subcontractor or new facility. Ask what the document actually covers and what evidence connects it to the product in front of you. This guide does not decide whether certification is required by a particular law, contract or customer agreement.

Synthetic workshop: a change with no linked review

Fictional manufacturer SAMPLE-WORKSHOP has an old equipment-cleaning procedure and a proposed change to a filling operation. No actual procedure, validation work, certificate or manufacturing record is supplied. The worked questions ask who owns the change, which product revisions are affected, what supporting records are needed and who will review the revised procedure.

The first useful action is to obtain the controlled records and agree the review scope. Ticking a generic GMP checklist would not demonstrate that the changed operation has been assessed. The specialist finding remains unresolved even if the requested files arrive.

Use an orientation to organise the next task

Keep requirements, evidence, operating records, review findings and corrective actions distinguishable. Record the exact manufacturing activity rather than a universal GMP-complete status. Where a question requires the full standard or an approved protocol, obtain lawful access through the responsible owner and record what was used.

Keep Ireland/EU, GB and NI applicability checks separate. The quality hub will link to the relevant released tasks as they become available. In the workspace, use an owned action for the missing record and a review of the exact product revision. Neither this guide nor a software check certifies manufacturing compliance.

Sources and legal dates