Cosmetic products are one of the most widely used category of personal care products across the globe. Hence, they should be manufactured in a safe and effective manner. To ensure the same, Health Authorities across the world have established certain Good Manufacturing Practices (GMP). In Europe, the Cosmetic Regulation (EC) 1223/2009 directs manufacturers to adhere to the ISO 22716 standard while producing the cosmetic products.

Good Manufacturing Practices as per the ISO 22716 standard

ISO 22716 defines certain quality and safety standards for cosmetic products to be placed in the European market. It standardizes below-mentioned aspects to be taken care of:

1. Premises

The premises should be located and designed in such a way that it should ensure the product’s safety and efficacy and must be regularly sanitized and maintained properly to avoid contamination of raw materials/products/operational flows.

2. Equipment

The equipment used must be suitable for the purpose of the product and manufacturing process. They must be kept in a condition that avoids any cross-contamination.  

3. Raw Material and Packaging items

The raw material and packaging items used in the manufacturing process are required to meet a defined and relevant set of criteria to ensure the quality of the finished product. The manufacturers must establish a dynamic supplier chain process for the raw materials to easily trace any issues that might arise during procurement. In addition, the purchase and reception of raw materials are also subject to strict rules and must only be carried out by qualified personnel.

4. Manufacturing Process

To ensure that the finished cosmetic product meets the quality standards, various precautionary steps must be taken, such as:

  • The process of manufacturing must be summarized and documented properly along with the relevant information about raw materials, formula, and the equipment required
  • Quality control points must be clearly identified
  • Batches should be numbered and labeled properly for easy identification
  • To minimize the contamination risk, manufacturing facility must be checked thoroughly for uncompromised safety

5. Finished Product

Organizations must set certain quality standards for the finished product prior to the initiation of the manufacturing process. These quality standards must also be maintained throughout the storage, supply, and distribution of the product. When the product is placed in the market, it must comply with the defined quality standards.

Complying with the GMP requirements of a region is necessary in order to deliver safe and effective cosmetic products to any market. Failing to do so may result in possible product recalls and a significant financial burden. To avoid them, start aligning with region-specific GMP requirements; in case of the EU, align with the GMP guidelines as per the ISO Standard 22716 and be prepared for sudden audits. 


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