ISO 22716 Certification | ISO 22716 | ISO 22716 Requirements

WHY CHOOSE ISO 22716?

Adopting ISO 22716 helps cosmetic manufacturers:

Achieve Regulatory Compliance: Align with global regulatory requirements and meet the stringent demands of international markets.
Enhance Product Quality and Safety: Implement consistent and reliable processes that minimize contamination and ensure the safety of cosmetic products.
Build Consumer Trust: Demonstrate a commitment to excellence, thereby enhancing brand reputation and consumer confidence.
Streamline Operations: Optimize manufacturing processes, reduce waste, and improve overall efficiency.

WHAT IS ISO 22716?

ISO 22716 is an extensive set of guidelines focused on Good Manufacturing Practice (GMP) for the cosmetics industry. These guidelines cover all aspects of production, control, storage, and shipment of cosmetic products.

Cosmetic products include any personal care items designed to enhance, cleanse, or modify a consumer's appearance or body. This category encompasses a wide range of products such as makeup, oral care items, creams, deodorants, hair care products, and fragrances.

The International Organization for Standardization (ISO) is a globally recognized non-governmental organization that develops standards across various industries.

In 2007, the International Cooperation on Cosmetic Regulations (ICCR)—comprising the United States, Canada, the European Union, and Japan—decided that ISO 22716 would serve as the standard for recommending or establishing cosmetic GMP guidelines for each member country. As a result, ISO 22716 has become the foundation for cosmetic GMP on an international scale.

In 2013, the U.S. Food and Drug Administration (FDA) updated its GMP guidelines to incorporate the recommendations outlined in ISO 22716.

Current Good Manufacturing Practices (cGMP) for cosmetics emphasize that companies must adopt tools and technologies that align with the latest ISO standards.

GOOD MANUFACTURING PRACTICE COSMETICS STANDARD

ISO 22716 sets the standard for Good Manufacturing Practices (GMP) in the cosmetics industry. Certification under this standard enables businesses to identify and mitigate production risks, ensuring product safety and quality and demonstrating a strong commitment to consumer protection.

GMP is essential for cosmetics compliance, offering a comprehensive framework for quality management. It guarantees that every aspect of product design, formulation, manufacturing, packaging, storage, and shipment is carried out safely, hygienically, and responsibly.

A cosmetics business's success depends on its ability to produce safe, high-quality products. Mastering GMP principles is crucial, as it enhances product safety throughout the supply chain and ensures consumer protection.

GLOBAL GMP REGULATIONS

In the European Union, all cosmetic products must comply with cGMPs based on the ISO 22716 standard, as mandated by Cosmetics Regulation 1223/2009.

Following GMP guidelines goes beyond legal requirements; it ensures that products meet high standards of quality, safety, and effectiveness, which can enhance sales and customer loyalty.

While the EU enforces mandatory compliance with good manufacturing practices for cosmetics, regulations in the US and Canada differ. Historically, the FDA and Health Canada have strongly recommended adhering to GMP standards, but compliance has not been mandatory. Changes are expected in 2024 regarding this approach.

KEY COMPONENTS OF ISO 22716

Personnel: Ensures that all staff are adequately trained, maintaining high standards of hygiene and competence.

Premises: Specifies requirements for facility design and maintenance to prevent contamination and ensure a clean production environment.

Equipment: Outlines the necessary standards for the maintenance, cleaning, and validation of equipment used in the manufacturing process.

Raw Materials: Provides guidelines for the receipt, storage, and handling of raw materials to maintain their quality and integrity.

Production: Establishes detailed procedures for each stage of the production process to ensure product consistency and safety.

Finished Products: Covers the storage, shipment, and quality control of finished goods to guarantee they meet specified standards.

Quality Control: Implements rigorous testing and monitoring procedures to ensure ongoing compliance with quality standards.

Subcontracting: Ensures that any outsourced activities adhere to the same high standards of GMP.

Complaints and Recalls: Provides a structured approach to handling customer complaints and product recalls efficiently and effectively.

Change Control: Manages changes in the production process or materials to ensure continued compliance with GMP.

KEY BENEFITS OF ISO 22716:

ISO 22716 certification offers significant benefits, including enhanced market access by meeting the demands of global retailers and distributors, and a competitive edge through a demonstrated commitment to high standards and quality assurance.

It also promotes operational excellence by improving efficiency and reducing the risks of product defects and recalls, while providing legal protection by adhering to internationally recognized standards for quality and safety.

REQUIREMENTS OF ISO 22716:

The requirements of ISO 22716 for cosmetics manufacturing encompass a range of aspects aimed at ensuring the quality, safety, and consistency of cosmetic products. Here are the key requirements:

Quality Management System (QMS):

Establish and maintain a robust QMS to manage processes and ensure product quality.

Personnel:

Provide adequate training and ensure personnel competence in their assigned tasks.
Maintain high standards of personal hygiene among staff involved in manufacturing processes.

Premises:

Design and maintain facilities to prevent contamination and ensure cleanliness.
Control environmental conditions such as temperature, humidity, and ventilation as needed.

Equipment:

Validate and maintain equipment used in the manufacturing process to ensure proper functioning and hygiene.

Raw Materials and Packaging:

Establish procedures for the receipt, storage, and handling of raw materials and packaging to prevent contamination and ensure traceability.

Production:

Implement detailed procedures for the production process to ensure consistency and safety of cosmetic products.
Document all steps of production and ensure adherence to approved formulations and recipes.

Quality Control:

Conduct regular quality control checks throughout the manufacturing process to monitor product quality and safety.
Implement corrective and preventive actions (CAPA) when deviations from standards are identified.

Finished Products:

Establish procedures for the storage, handling, and shipment of finished products to maintain quality until delivery to the consumer.

Subcontracting:

Ensure that subcontracted activities related to manufacturing meet the same quality and safety standards as those within the company.

Complaints and Recalls:

Develop procedures for handling consumer complaints and initiating product recalls when necessary to ensure consumer safety.

Documentation and Records:

Maintain comprehensive documentation and records of all activities and processes related to manufacturing, quality control, and compliance with ISO 22716.

Continuous Improvement:

Implement a system for continuous improvement, including regular internal audits and management reviews to identify areas for enhancement and ensure ongoing compliance with ISO 22716.

THE ASI DIFFERENCE

ASI can assist companies with ISO 22716 by providing expert guidance and certification services tailored to the cosmetics industry. ASI ensures that businesses understand and implement the rigorous Good Manufacturing Practices (GMP) required by ISO 22716, helping them achieve compliance, enhance product quality and safety, streamline operations, and access global markets with confidence.

Their accredited certification process verifies adherence to international standards, reinforcing credibility and demonstrating commitment to excellence in cosmetics manufacturing.

FREQUENTLY ASKED QUESTIONS:

What is ISO 22716?

ISO 22716 is an international standard that provides guidelines for Good Manufacturing Practices (GMP) specifically tailored to the cosmetics industry. It covers all aspects of production, control, storage, and shipment of cosmetic products.

Why is ISO 22716 important for cosmetics manufacturers?

ISO 22716 helps cosmetics manufacturers ensure consistent product quality and safety. It provides a framework to meet regulatory requirements, enhance operational efficiency, and build consumer trust.

What does ISO 22716 certification involve?

ISO 22716 certification involves implementing and maintaining GMP principles outlined in the standard. It requires companies to establish and document procedures for all stages of cosmetics production, from raw materials to finished products.

How does ISO 22716 benefit cosmetics companies?

ISO 22716 certification offers several benefits, including:

Regulatory Compliance: Meeting international GMP requirements.
Enhanced Product Quality: Ensuring consistent quality and safety.
Operational Efficiency: Streamlining manufacturing processes.
Market Access: Facilitating entry into global markets.

Is ISO 22716 certification mandatory?

ISO 22716 certification is not always mandatory but is highly recommended to meet regulatory expectations and market demands for high-quality cosmetics.

How can my company get ISO 22716 certified?

To obtain ISO 22716 certification, companies typically undergo an audit by a certification body accredited by ISO. The process involves assessing adherence to GMP principles and implementing corrective actions where necessary.

What are the key components of ISO 22716?

Key components include requirements for personnel training, facility design and maintenance, equipment validation, raw material handling, production processes, quality control, and product storage and shipment.

How often is ISO 22716 certification renewed?

ISO 22716 certification requires regular audits to maintain compliance. Certification bodies typically conduct audits annually or biannually, depending on the organization's policies.

Where can I find more information about ISO 22716?

For detailed information on ISO 22716, including implementation guidelines and certification procedures, refer to the official ISO website or consult with accredited certification bodies specializing in cosmetics GMP.

ISO 22716