1. Introduction
The requirements in the cosmetic sector are defined in the regulation of the CE Nº 1223/2009 of the European Parliament and of the Council about cosmetic products that was published in the Official Journal on December 22, 2009, that entered into force on January 11, 2010 and that is applicable sinde July 11, 2013.
Download regulation (CE) No 1223/2009
2. Regulation 1223/2009
In this regulation the basic points are:
-
- Definition and obligation of responsible person
- Content of the information file about the product
- Security evaluation of the medicines
- Prohibition of animal use for experimental purposes
- Restrictions for the use of certain substances
- The manufacturing will be done within good manufacturing practices.
3. GMP in the manufacturing of cosmetics
For the compliance of the good manufacturing practices in the cosmetic field a regulation UNE-EN-ISO22716 has been developed.
This rule establishes the guidelines of good manufacturing practices in the production of cosmetic products according to the European Regulation bases, mainly focused on the managament of the factors related to the manufacturing of the products, with a view to eliminate and prevent deficiencies in the quality control. and its impact on the consumers.
The regulation is structured in the following chapters La norma se estructura en los siguientes capítulos:
– Purpose and scope of application.
– Terms and Definitions.
– Personnel.
– Premises.
– Equipments.
– Raw materials y Packaging Materials.
– Production.
– Finished products.
– Quality Control Laboratory.
– Product Treatment out of Specifications.
– Wastes.
– Types of Subcontracts.
– Deviations.
– Claims and Market Withdrawals.
– Exchange Control.
– Internal Audit.
– Documentation
The AEMPS will audit the plant againts this regulation and will emit a GMP certificate that englobes the following information.
4. FDA Status
The FDA has published the new Good Manufacturing Practice Guide for Cosmetic Products that include recommendations about documentation, storage, facilities and services, raw materials, processing and packaging, internal audits, laboratory controls, claim management and reports of adverse events, and the management of market withdrawals.
Download Guidance for Cosmetic GMP
This new document inspects the actual “Cosmetic Good Manufacturing (GMP) Guidelines/Inspection Checklist”, and updates it to the current requirements of good practices.
Download GMP Guidance/Inspection checklist
Additionally FDA tries to harmonise its requirements with those of the ISO 22716, despite that it includes only the relevant elements for its regulations and adds some others that are not included included in the ISO 22716. It also mentions the Guidance for Industry on Cosmetics Processors and Transporters of Cosmetics Security Preventive Measures, which was revised in 2007.
5. Ingelyt Support
Ingelyt can realize in the cosmetic field a global solution that incorporates both adaptation of the facilities and the implementation of the quality system enshrined in the regulation UNE-EN-ISO 22716 for the GMP certification of the manufacturing plant by the health authorities both in Europe and the USA.
If you wish the applicable regulation or a clarification about it, or any other additional information, feel free to contact us.
Alberto Carazo
acarazo@ingelyt.com
Tags:
En INGELYT estamos a la vanguardia y somos pioneros en el sector en cumplir con el Diseño, Implantación y Mantenimiento de Planes y Programas de Prevención y Gestion de Riesgos Legales y Penales (CORPORATE COMPLIANCE)