Cosmetics
ISO 22716:2007
Cosmetics: good manufacturing practices (GMP), guidelines
ISO 22716 gives guidelines on good manufacturing practices (GMP) for cosmetic products: how their production, control, storage and shipment are organised so that products are made consistently and to the quality intended.
It is a guidance document, not a set of requirements. It does not cover research and development, the distribution of finished products, or the safety of staff and the environment.
Who it suits
Manufacturers of cosmetic products, and contract manufacturers, fillers and packers, that want an independent check of their manufacturing practice, for example for their customers. Where a regulator requires certification or inspection by a named body, this certificate does not replace it.
What certification involves
ISAO audits the site's operations against the guidelines of ISO 22716, using its own documented audit criteria, and the certificate names the product types, activities and site covered. Because the standard is a set of guidelines, the certificate states that the operations were found to be operating in accordance with its guidelines. ISO certifies no one. It is a voluntary certificate: it is not a manufacturing licence, a product registration or notification, or an approval by any authority, and on its own it does not establish compliance with legal good manufacturing practice requirements. In the European Union, for example, manufacturing in accordance with the harmonised standard EN ISO 22716 gives a presumption of conformity with the cosmetics regulation, whatever certificate a manufacturer holds. ISAO carries out this certification itself and records every certificate it issues on the public register. It does not accredit certification bodies for it.
Key themes
- Trained personnel with clear responsibilities, and hygiene rules for everyone on site
- Premises and equipment designed, cleaned and maintained to protect the product
- Raw materials and packaging materials bought, received, identified, stored and released under control
- Production carried out to documented instructions, with batch records
- Quality control of materials and finished products, and handling of results out of specification
- Subcontracting, deviations, complaints and recalls, and change control
- Internal audit and documentation
What the certificate is not
Certificates ISAO issues for ISO 22716:2007 carry this statement:
This is a voluntary certificate issued by International Standards Accreditation Organization (ISAO). It is not issued under accreditation and is not valid for import, export, product registration, notification or licensing purposes. ISO does not certify organisations and has not approved this certificate. It is not a manufacturing licence, registration, notification or approval by any authority (for example a State Licensing Authority in India, the US FDA, OPSS in Great Britain or an EU competent authority), and it does not by itself establish compliance with legal good manufacturing practice requirements such as Article 8 of Regulation (EC) No 1223/2009. Research and development and the distribution of finished products are outside its scope. It does not certify the safety or quality of any product.
Edition
- Current edition
- ISO 22716:2007
ISO 22716:2007 is the current edition. ISO last reviewed and confirmed it in 2022.
Check a certificate for ISO 22716:2007
- Enter the certificate number or verification code at Verify a certificate, or scan the QR code on the certificate. The record shows the certificate's status today, for example valid, suspended, withdrawn or expired.
- Compare the organisation name, scope and site on the record with the copy you were given. Check the product types, activities and site named in the scope.
- Check that the record names ISAO as the issuer: ISAO issues its certificates for ISO 22716:2007 itself. Read the disclaimer on the record, which is also printed on the certificate: it says what the certificate is not, and that no authority issued or approved it.
- If the certificate is not on the register, ISAO cannot confirm it: another organisation may have issued it, or a detail may be wrong. Ask whoever gave it to you, and report a concern if something does not look right.
Related standards
This is ISAO’s own summary, not the text of the standard. Copies of ISO 22716:2007 can be bought from ISO or from national standards bodies.