Cosmetics Module 2

• Cosmetics Regulation 1223/2009


  Requires that all cosmetic products placed on the European market comply with GMP set by ISO 22716 standard
• ASEAN Guidelines for Cosmetic and GMP

  Have been produced to offer assistance to the cosmetic industry in compliance with the provisions of the ASEAN cosmetic directive

  - Intended for cosmetic products and presents GMP for manufactuerers
• Cosmetic Good Manufacturing Practice


  This guidelines ensure that the products are consistently manufactured and controlled to the specified quality
• Quality management system


  Should be developed, established, and implemented as a means by which stated policies and objectives will be achieved
• Quality Control


  Is an essential part of GMP. It provides assurance that cosmetic products will be of consistent quality and appropriate to their intended use

  - Should be established to ensure specification meets standard
• Reprocessing


  The methods of this Process should be evaluated to ensure that they do not affect the quality of the product
• Returned products


  These should be identified and stored separately either in allocated area or by moveable barrier such as rope or tape

  - Shouldbe tested if necessary
• Documentation system


  It should include the complete history of each batch, from starting materials to finished products.
• Name and material, Description of material, testing parameters and acceptance limits, technical drawings, special precautions


  Raw packaging material specifications should include the following
• name of product, description, physical properties, chemical and/or microbiological assay and their acceptance limits, storage conditions and safety precautions


  Bulk and finished product specifications should include
• Product name and code number, intended packaging materials and storage conditions, raw materials used, equipments used, in-process controls with their limits

  The master formula should contain the following information.
• Internal audit


  Consists of an examination and assessment of all or part of a quality system with specific purpose of improving it

  - May be conducted outsider or independent specialist