Cosmetic

The chemical / cosmetic industry is a broad-spectrum, characterized by the centrality of research and by the study of the transformation of matter. The international competitors are more aggressive and to be competitive, research activity should be more structured and qualified. The industry is subject to strict safety requirements and to a variety of regulatory compliance. Of particular importance are cosmetic GMP ISO 22716 and obviously REGULATION (EC) No. 1223/2009 of the European Parliament which lays down that each cosmetic product placed on the market must comply with it in order to ensure the proper functioning of the internal market and a high level of protection of human health. Blulink is able to support companies in the sector by delivering always-compliant with the regulations in the field of pharma and the internal structure of processes in the audit.

---

Overview

The Regulation is essentially a reconstruction of the Cosmetics Directive and does not introduce fundamental changes in the product information requirements provided for by the Directive . Concepts and general content of the information on the product, as well as the availability to the public certain information , are substantially unchanged. The main change is the reworking of some of the information , including the Safety Assessment within a Cosmetic Product Safety Report ( CPSR ), as described in detail in Annex I of the Regulation . The Regulation continues with the introduction , for the first time , the term " product information file " ("Product Information File ," PIF ) , referred to Article 11: [...] When a cosmetic product is placed on the market , the responsible person shall keep records information about it. The product information file shall be retained for a period of ten years after the date on which the last batch of the cosmetic product was placed on the market. [...] In short, the P.I.F. 5 must contain the following types of information :

• Product Description ( Article 11.2.a );
• Report on the Safety of Cosmetic Product ( Article 11.2.b );
• Method of manufacture and compliance with the GMP ( Article 11.2.c );
• Evidence of the effect attributed to the product ( Article 11.2.d );
• Data relating to animal experimentation ( Article 11.2.e ) .

The Regulations require that the P.I.F. be stored in electronic format or any other format (eg . paper) , provided it is immediately available to the competent authorities in the Member State in which the PIF is required . The text concerning the language used for the PIF asserts that the information should be easy to understand for the official control if it is to verify the PIF is available in the State where it is kept . Therefore, it is of course the interest of every company to make the PIF document. Document management through the Quarta EVO becomes compliant with GMP regulations and the industry. Blulink is able to support the management of all necessary documentation , with the trappings of security and data access as well as by regulatory and GMP . Thanks to the workflow and management of the Life Cycles you can also manage document revisions , store and distribute the obsolete versions in a safe and accurate documents within the company.

Experiences

Thanks to its experience in the field of Pharma, partnering with major facilities management and advisory LIMS, Blulink can boast a range of skills to support the companies in the cosmetics in ensuring effective processes also contemplating compliance with regulations and industry standards .