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What are the big differences between GMP and ISO 22716?

What are the big differences between GMP and ISO 22716
ISO 22716

What are the big differences between GMP and ISO 22716?

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Good Manufacturing Practices GMP is different from the ISO 22716,  GMPs are organizational guidelines laid out to ensure the quality and reproducibility of the manufacturing process of cosmetic products, food and beverages, and pharmaceutical products are followed. The FDA uses GMP to regulate different industries and to protect the end-user. As such, the guidelines differ from one sector to the other.

 

ISO 22716

 

Good Manufacturing Practices for cosmetic products are regulated through the ISO 22716 standard. The guidelines were set out as a result of the constant scrutiny on cosmetic products concerning the presence of hazardous ingredients. The guide emphasizes the quality of cosmetic products about the end-user, traceability, and accountability in the production and distribution process of the product. Companies not only commit to following guidelines for their business path but also ensure safety, excellence, and quality of the product. The main objective of the ISO 22716 is to:

 

  • Ensure compliance of the business management system with the European Cosmetics Regulation requirements

 

  • Provide access to the European market

 

 

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ISO 22716 Guidelines

 

ISO 22716 standards describe the different measures a company should adopt when complying with Good Manufacturing Practices. It addresses issues regarding:

 

  • Staff: They should belong to a structured organization where each employee knows his responsibilities about the production, storage, control and shipment of cosmetic products

 

  • Premises: Measures should be taken to keep the premises clean, sanitized and maintained while minimizing product contamination

 

  • Equipment: The equipment should be designed to reduce the risk of contamination

 

  • Raw materials: The company should select suppliers based on specific quality criteria

 

  • Manufacturing: The company should provide a summary of the production process of the product, determine quality control areas, examine the cleanliness and safety of the equipment before production to reduce the risk of contamination

 

  • Waste: Companies are required to define the types of waste generated during the production of cosmetic products. Their proposal should be done in a controlled way to avoid waste streams from hampering production and control processes

 

  • Finished products: They should comply with the quality standards established by the company and the industry

 

  • Internal audits: The company should implement internal audits to ensure GMP standards are implemented. The audit team should set up and verify that all ISO 22716 guidelines are included

 

  • Documentation: Companies should have a documentation system that records activities regarding control, production, storage and shipment of cosmetic products

 

 

Differences Between GMP and ISO 22716

 

Apart from one standard being a subset of the other, there are a few differences between GMP and ISO 22716. The most notable is the choice of expression used by the two standards. GMP gives directives using the phrase ‘it is due to’ while ISO uses ‘it is proper to.’

As such, ISO standards provide room for flexibility while GMP makes it mandatory for companies to follow the guidelines. Also, the topics covered by the ISO 22716 are different and less detailed than those addressed on GMP.

 

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ISO 22716 2017

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