The ISO 22716 is a guidance document prepared by International Organization for Standardization (ISO), detailing Good Manufacturing Practices (GMP) for cosmetic products manufacturing. It applies to all stages of the cosmetics manufacturing process, from sourcing raw materials to the final packaging and shipment of the finished product. The standard is developed by experts from all over the world.  However, it does apply to research and development activities and distribution of finished products.

The guidelines cover the quality aspects of a product, but as an entire do not include safety for personnel or protection from environmental damage.

ISO 22716 is a voluntary standard, but many cosmetic companies choose to follow it to demonstrate their commitment to quality and consumer safety. The standard is also recognized by regulators around the world, which makes it easier for companies to do business internationally.

The standard is sometimes referred to as Cosmetic GMP Guidelines, Good Manufacturing Practices for Cosmetics, and Cosmetic GMP Standards.

ISO 22716 is an International Standard and therefore sets global expectation when applying the standard within a cosmetic product manufacturing business.

Good Manufacturing Practices (GMP)

Good Manufacturing Practices (GMP) are practices that promote high and consistent quality products if followed and are the foundation of ISO 22716. They cover all aspects of cosmetic production, from raw materials to finished products. GMP is also designed to ensure that cosmetic products are always safe.

The ISO 22716 standard incorporates the following elements:

• • • • Quality Control: testing of incoming goods, in-process controls testing and outgoing finished products testing, setting acceptance criteria
      • Quality assurance: compliance to ISO 22716 standard, monitoring of processes, storage, product recall, handling complaints, documentation
      • Supply chain: raw materials, packaging materials
      • Production: batch manufacturing

Quality and Safety compliance

ISO 22716 provides a framework for the development of quality and safety systems in the cosmetics industry.

Cosmetic companies that follow ISO 22716 can be sure that their products will always meet the highest standards of quality and safety. This makes it easier to do business internationally and strengthens customer confidence in the company’s products.

Legal Requirement

It is the responsibility of cosmetic companies to ensure that their products comply with all relevant legal requirements.  In many countries, cosmetics regulation requires a company to comply with ISO 22716 before the cosmetic product can be sold as this forms part of consumer safety requirements.

What are the benefits of ISO 22716?

Incorporating ISO 22716 in cosmetic products manufacturing businesses is highly encouraged as it helps:

• • • • support continuous improvement
      • supply chain management
      • manage quality and safety
      • create a comprehensive approach to standardising practices
      • setup acceptance criteria, specifications, and control

Continual improvement

The ISO 22716 standard does not outline the requirement for continuous improvement explicitly, however, there are elements within the guide that supports continual improvement such as monitoring activities and taking corrective actions. Ensuring continuous improvement can be achieved when combining ISO 22716 and ISO 9001 – Quality Management Systems.

Supply Chain Management

A supply chain is a system of organizations, people, activities, information, and resources involved in moving a product or service from supplier to customer. Supply chains begin with the suppliers who provide the raw materials or packaging components used in the manufacturing process and end with the customers who use or consume the finished cosmetic products. In between these two extremes are a variety of activities that add value to the product or service as it moves down the supply chain. These activities include transportation, warehousing, inventory management, packaging, and more. Supply Chain Management is the oversight of these activities. An effective supply chain ensures that products and services are delivered to customers in a timely and cost-effective manner. Supply chains can be complex; however, they play a vital role in the global economy.

Quality Assurance

Quality assurance is an important aspect of any manufacturing process, but it is especially critical in the production of cosmetics. Consumers expect cosmetic products to meet high standards of quality and safety, and quality assurance procedures help to ensure that these expectations are met. Quality assurance teams work to develop and implement protocols that will ensure the consistent production of high-quality products. These protocols may include testing raw materials for impurities, monitoring production processes for compliance with quality standards, and conducting final inspections of finished cosmetic products. By investing in quality assurance, cosmetic manufacturers can help to protect their brand image and bottom line.

Standardised practices 

In the cosmetics industry, standardised practices are vital in ensuring that products are safe and fit for purpose. These practices help to minimise the risk of contamination and ensure that products meet regulatory requirements.

Several standardised practices are commonly used in cosmetics manufacturing, such as Good Manufacturing Practices (GMPs) and Hazard Analysis and Critical Control Points (HACCP).

GMPs are a set of practical methods that aim to ensure finished products are of high quality and safe for consumers.

HACCP, on the other hand, focuses on identifying and controlling potential hazards at every stage of the manufacturing process. By adhering to standardised practices, cosmetics manufacturers can help to ensure the safety and quality of their products. The main output of standardising practices is to provide practical methods and guides to employees within the organization on how to deal with events and situations effectively and efficiently.

Consumer Safety

Consumer safety is always a top priority in the cosmetics manufacturing industry which is stringently regulated to ensure that consumers are not exposed to any harmful ingredients. All cosmetic products must undergo a rigorous testing process before they can be sold to the public. In addition, cosmetics manufacturers are required to list all of the ingredients used in their products on the labels. This allows consumers to make informed choices about which products they use.

ISO 22716 Certification

Although compliance with ISO 22716 may be a legal requirement in many jurisdictions, certification against the standard may not be required. Cosmetic manufacturing businesses can either be self-disciplined to implement the standard rigorously, or they can be externally audited and certified by external certification bodies. Being externally certified demonstrates that the business is:

• Willing to undergo third-party audits
• Committed to meeting customer requirements
• Serious about quality and consumer safety
• Demonstrate compliance

Research and development activities

Research and development activities are not covered by ISO 22716, but they are an important part of the cosmetics manufacturing process. Many cosmetic companies choose to follow ISO 9001 for their research and development activities. This international standard provides guidance on quality management systems for all types of organizations.

How can I get started with ISO 22716?

There are a few ways you can get started with ISO 22716:

• Find a certified supplier: A certified supplier can help you develop and implement a quality management system that meets the requirements of ISO 22716.
• Use a self-assessment tool: You can use a self-assessment tool to assess your company’s readiness for ISO 22716 certification.
• Attend a training course: A training course can help you understand the requirements of the standard and how to apply them to your business.
• Hire a consultant: A consultant can help you develop and implement a quality management system that meets the requirements of ISO 22716.

OR, why not talk to us – we can help.