ISO 22716 Cosmetics Good Manufacturing Practices

Backup 2/12/2022



  Overview of ISO 22716:2007 Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices

Safety is an important concern for cosmetic goods.

These are products that customers will put on their bodies and may contain ingredients that could potentially cause an allergic reaction.

ISO 22716 is an international standard of good manufacturing practices (cGMP) for the cosmetics manufacturing industry and describes the basic principles of applying cGMP in a facility that produces finished cosmetic products. This guideline offers organised and practical advice on the management of human, technical and administrative factors affecting product quality.

Who Should Use ISO 22716?

1. In Malaysia, similar to the EU responsible person, an organization is required to have a responsible person to notify the cosmetic products (known as the “Cosmetic Notification Holder” in Malaysia) to ensure the cosmetic products meet all stipulated regulations and guidelines for Cosmetics products. This person among things is to ensure organisations follow good manufacturing processes as laid out in ISO 22716 guidelines on good manufacturing practices.

2. Any organisation involves in the cosmetic process, not only limited to production but also the control, storage, and transportation of products, including the purchase of raw materials, components and packaging material.

3. If you want to ensure your production and specification of cosmetics result in products that are safe to use.

1. ISO 22716 helps you improve your brand image, facilitates your exports, and prepares you for inspections by the relevant authorities.
    
2. Helps you ensure quality and safety compliance throughout every stage of the supply chain. This leads to a better final product which is produced at the highest standard and with customer safety in mind while ensuring a safe environment for employees. 
    
3. Improves your business’s reputation and also safeguard your products from potential issues such as contamination or a lack of quality control.
    

4. You want to control of hazards and risks associated with cosmetic products.
    

5. Reduces the potential hazards of your cosmetics manufacturing and promotes better manufacturing practices to protect your employees and also the environment.
    

6. You want to ensure your processes are adhering to the regulatory and legislative requirements of Malaysia and relevant exporting countries.  All cosmetics products circulating in the EU have to be produced according to the Cosmetics Good Manufacturing Practices described by the ISO 22716 standard. Compliance with this standard can be demonstrated either by the ISO 22716 certificate or by a declaration stating that the products are produced according to ISO 22716. ISO 22716 opens up your cosmetic products into the EU market. 
    

7. You want to enhance the image of the company in safe cosmetic production.
    

8. You want to demonstrate to your customers, suppliers and external stakeholders that you are committed to being a safety-conscious organisation, which can inspire both increased sales, as well as overcoming regulatory barriers to entry for certain projects/businesses.

9. Regulators and customers alike are increasingly demanding food safety be taken into account by the organisation they are purchasing from or working with. In the absence of a cGMP system, you risk losing customers to competitors that see the value in showing their customers they have a cGMP management system.

10. You may face the risks and lost opportunities involved with not having an ISO 22716 cGMP system in place and risk being known as the organisation that doesn’t take safety concerns onboard as you operate. 

11. You will potentially be eligible for more lucrative, large scale both government and private sector contracts that are only offered to organisations that can provide proof of their commitment to safety and who can meet their standards.

1. conduct Gap Analysis;
2. establish implementation schedule and plan;
3. appoint cGMP Committee;
4. establish a documentation framework; and
5. have a fundamental understanding of the requirements of ISO 22716.

1. cGMP Manual;
2. Job Description;
3. cGMP Procedures;
4. cGMP Supporting Process Procedures;
5. cGMP System Procedures; and
6. cGMP Forms, Work Instructions and others.

1. Guidance and advice on the implementation of the documented cGMP.
2. To conduct ISO 22716 cGMP Internal Audit Training.
3. To conduct an ISO 22716 cGMP Internal Audit.
4. To conduct an ISO 22716 cGMP Management Review Meeting.