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The difference between GMPC certification of cosmetic quality management system and ISO22716 certifi
Time:2022-03-24 Clicks:

If cosmetics want to be sold in the US and EU markets, they should comply with the US Federal Cosmetics Regulations or the EU Cosmetics Directive, namely GMPC, the full name of GMPC is Guideline for Good Manufacture Practice of Cosmetic Products (Good Manufacturing Practice for Cosmetics), which can be divided into GMPC (US ) American standard, GMPC (EU) European standard, GMPC (ASEAN) ASEAN standard, respectively regulated by the US FDA, the European Commission and the ASEAN Committee.


  ISO22716 is a certification that can be done for the European market for the latest EU regulation (EC) NO 1223/2009. Compliance with this harmonized standard means compliance with EU cosmetics regulations,


   After July 11, 2013, cosmetic products exported to the EU must be certified.


The main difference between   GMPC and ISO22716 is:


  GMPC is not a mandatory standard, but a guideline to encourage implementation, while ISO22716 is a mandatory requirement for cosmetics to enter the EU.


   In fact, the content of GMPC and ISO22716 is similar, including five parts: quality system, procurement, production, subcontracted production and quality management.


  The main contents include:


  Personnel: Only those who have passed the entry health examination can engage in cosmetic production, and the employees must have good personal hygiene and habits. Skills and hygiene training for all employees.


   Plant facilities: Whether it is the design of the workshop, the selection of building materials, or the design and installation of the production line, waste and sewage treatment, appropriate precautions should be taken to prevent the potential harm of foreign pollutants.


   Reasonable structure, avoid cross contamination, keep clean, have good hand washing and toilet facilities.


  Sanitation control: Strictly clean and disinfect the daily workshop, equipment and tools. Develop cleaning and disinfection schedules and maintain work records.


   Develop and implement a pest control plan, and there must be no animals or pests in the factory.


  Equipment: All plant equipment and utensils, their design, materials and workmanship, must facilitate adequate cleaning and proper maintenance.


   Seams that touch the surface of the product must be smooth.


  Processing control: All operations in the feeding, inspection, processing, packaging and storage of cosmetics must be carried out in strict accordance with the requirements to ensure the hygiene and safety of the products.


  QC/QA (Quality Control and Quality Assurance) should establish inspections from raw materials to finished products, test plans, correct testing methods, all instruments must be in good calibration, and a procedural document and record management system.


   Internal audit is an effective tool to check whether GMP is effectively implemented. Internal audits are conducted at least once a year.


  Product Recovery: All finished products are traceable back to the raw materials used. Establish procedures for product recycling, conduct annual recycling simulations and maintain records.