Cosmetics good manufacturing practices (GMP) – UNI EN ISO 22716
Although both European and Italian regulations are exhaustive and very detailed with regard to the marketing and use of cosmetic products, up to just a few years ago there was no clear definition of the manufacturing standards ensuring systematic compliance with well-defined qualitative levels.
This regulatory gap was fulfilled in October 2007 with the issue of the EN ISO 22716 global standard defining the state of the art in cosmetic industry guidelines. The transposition into Italian law (UNI EN ISO 22716) resulted in an increasing awareness among Italian companies about the need to adjust to and comply with the requirements set by the guidelines on cosmetics good manufacturing practices, and to have such commitment endorsed by certification organizations through the evaluation of their product safety and quality management system, at a national as well as global level.
TÜV Italia supports companies by providing a compliance certification under the guidelines established by the UNI EN ISO 22716 regulation as an integration to the ISO 9001 certification of cosmetic manufacturing companies.
Our services at a glance
Performed upon request, it consists of a preliminary audit aimed at analysing any deficiencies and evaluating the company’s compliance to the requirements of the global standard.
Cosmetic compliance certification audit
In order to obtain the compliance certification, the company undergoes a number of audits, including:
- management system implementation audit
- document review
- on-site observations
- personnel interviews
The positive outcome of the above leads to the issue of the first certification.
For companies already certified under ISO 9001 with TÜV Italia, this audit is preferably performed in conjunction with the ISO 9001 certification/certification renewal or with other inspections and is normally planned in advance.
For companies already certified under ISO 9001 with a different organization, the audit focuses on compliance to the Guidelines and on those aspects of the Quality Management System that support their systematic application.
For companies with no certified Quality Management System, such supporting elements need to be examined in depth during the preliminary stage of the process.
TÜV Italia performs periodical visits according to the inspection schedule specified in the ISO 9001 certification report. In addition, in conjunction to the three-yearly cycle typical of Management System inspections, every three years a more exhaustive inspection will be carried out.
The certification has a one-year validity. In order to renew it the company is subject to auditing and, in case of positive outcome, TÜV Italia issues a new certificate.