What is the GMP?

Standard for the production and control of cosmetics in accordance with Regulation No. 1223/2009

Why GMP?

Compliance with cosmetic GMP in accordance with Regulation No. 1223/2009 Art. 8, is mandatory as of 13 July 2013. The new Regulation 1223/2009 introduced obligatory application of good manufacturing practice in accordance with applicable international standards and are based on the international standard ISO 22716: 2007 specifications.

How It Works?

ISO 22716 contains a list of requirements that must be met for a cosmetic product (guidelines, objectives, documentation…). Using good manufacturing practices by Regulation No. 1223/2009 required in the production of cosmetic products. Certification is not mandatory, although it is advisable, but mandatory compliance with ISO 22716: 2007 specifications.

Manufacture of cosmetic products must be in accordance with the principles of good manufacturing practice (GMP).

Production is consistent with good manufacturing practice if it complies with the relevant harmonized standards, it relied on Regulation in the Official Journal of the EU. In the EU Official Journal published Commission Communication in the framework of the implementation of Regulation (EC) No. 1223/2009 of the European Parliament and of the Council on cosmetic products. It was first published title and the reference to harmonized standard EN ISO 22716: 2007 Cosmetics – Good Manufacturing Practice (GMP) – Guidelines for good manufacturing practices (ISO 22716: 2007).

Standard ISO 22716: 2007 is an international standard that provides guidelines for the production, control, storage and shipment of cosmetic products. The guidelines are set out organizational and practical advice for managing human, technical and administrative factors affecting the quality of production.

Thus, the standard defines the following areas:

  • Staff
  • Business Space
  • Equipment
  • Raw materials and packaging materials
  • Production
  • Finished products
  • Products quality control
  • Handling of the product, which is not in accordance with specifications
  • Waste
  • Subcontractors
  • Derogations
  • Complaints and product withdrawals
  • Change Control
  • Internal Audit
  • Documentation

 

How can we help in the implementation of GMP or ISO 9001: 2008 in the company?

 

With our extensive experience and theoretical knowledge Finac d.o.o.. Helps with

  • Introduction
  • Implementation,

and

  • Documenting processes

in accordance with the guidelines for good manufacturing practices GMP (ISO 22716: 2007).

We will help you in designing and document processes and procedures in accordance with the guidelines and requirements of the standard. The company will, with our help identify and set up effective processes and a system of effective planning and achievement of objectives and control, management, and continuous improvement processes. We set up the Quality Management Manual, which will be the cornerstone of your competitive advantage.

In addition to regulatory compliance, your organization will be more efficient, more productive and hence more competitive.

ISO STANDARD AUDITING PROCEDURE BY CERTIFIED BODY IS NOT MANDATORY ACCORDING TO Regulation (EC) No. 1223/2009