What is ISO 22716 – Good Manufacturing Practices for Cosmetics?
ISO 22716 offers a solid foundation for ensuring quality and safety and enables manufacturers, suppliers, retailers, and wholesalers to minimize or eliminate incidents of contaminations, mix-ups, and other errors by controlling all the components that can affect product quality.
- ISO 22716 deals with all aspects of the supply chain of cosmetic products, from the early delivery of raw materials and components until the shipment of the final product to the consumer.
- It describes the basic principles of applying GMP in a facility that produces finished cosmetic products.
- ISO 22716: 2007 gives guidelines for the production, control, and shipment of cosmetic products
- These guidelines cover the quality aspects of the product. Still, as a whole, they do not cover safety aspects for the personnel engaged in the plant, nor do they cover aspects of protection of the environment.
In addition, the standard is relevant for retailers, brand holders, and wholesalers of cosmetic products. Furthermore, it specifies general requirements for quality management systems by incorporating a risk assessment-based approach to define critical and non-critical elements ensuring high-quality supply chain operations.
ISO 22716 Overview
ISO 22716 can be thought of as being composed of five core elements:
- The cosmetics Quality Management System and Organization
- Premises and Equipment
- Product Realization and Materials Management
- Deviations, Complaints and Recalls
- Continues Improvement
ISO 22716 QMS and Organization
- Setting up Effective internal and external communication channels.
- Participation and commitment of personnel at all levels of the organization.
- A controlled documentation system is, therefore, an intrinsic part of organizations working under ISO 22716.
- Establish and maintain a qualified personnel base that is well trained and capable of consistently producing safe products.
- A sound knowledge base of the personnel in a cosmetics manufacturing organization is of the utmost importance.
- A clear description of tasks and lines of responsibilities of all personnel in the organization.
Premises and Equipment
- Areas for manufacturing, storage, and quality control are crucial elements described in the standard.
- Areas should be fit for purpose to allow for proper access and flow of materials.
- Clear segregation of manufacturing and storage activities and proper cleaning & sanitization is essential to avoid mix-ups and (cross-) contamination.
- Scheduled maintenance of premises & equipment
- Frequent calibration of monitoring devices.
- Approve and evaluate all changes that occur and allow for an objective overview of results obtained.
Operations and Materials Management
- Set the criteria for quality during the different manufacturing stages, like specifications for purchased raw materials, components, and packaging materials.
- The criteria for checks should be established and release parameters of starting materials, intermediates (also called cosmetic ingredients), and finished products.
Deviations, Complaints and Recalls
- Each organization needs to have a system to deal with deviations occurring anywhere in the supply chain of operations.
- These deviations can have multiple origins and occur internally but also arise externally, for example, during transportation to a client organization.
- Complaints Management Process – Investigate complaints until a satisfactory solution has been found and communicated to the client.
- Auditing ‘Best Practice.’
- The internal audit is an intrinsic part of Cosmetics GMP
- An optimal auditing system is a basis for effective Corrective Action / Preventive Action (CAPA) planning.
- Quality through the supply chain.
Effective Risk Management
- Based on the concept of HACCP
- Cosmetics GMP is embodied by the:
– Analysis of all possible risks in an organization
– Identification of critical steps to control those risks
– Continuously improving product quality and safety
– Defining change control to safeguard product quality and safety
– Documentation and record-keeping under QMS
– Internal inspections and preparation of corrective and Preventive Action (CAPA) programs.
What are the requirements of ISO 22716?
ISO 22716 requirements version 2007
- Clear roles & responsibilities identified in objectives, Job Descriptions & Procedures
- Have the right skills & training in their job and are trained in GMP
- Health and Hygiene policy defines standards for workwear, eating and drinking, and how to handle the product.
- Good flow of product and plenty of space
- Designed for easy cleaning
- Well maintained
- Pest Control
- Designed to prevent cross-contamination
- Easy to clean
- Well maintained (preventive maintenance).
- Have a defined product specification
- Must control the release of the product to ensure all product meets the specification
- Procedure to deal with the returned product.
- QC only test a sample
- Sampling plan
- Test methods
- Standards and specification
- Process for out of specification product
- Part of your operation
- Have a defined contract & procedures
- The process to deal with issues and corrective actions.
Raw & Packaging Materials
- Purchased from evaluated supplier according to specification
- Good storage with clear identification and status control
- Don’t forget – water is a raw material! Make sure the water supply is well maintained it makes up most of your product.
Manufacturing and Packaging
- Controlled documents
- Startup checks
- In-process checks
- Handling of work in progress
- Handling of waste
What Are the Benefits of ISO 22716 to My Customers?
From the customer’s point of view, Cosmetics GMP works in the background and provides them with peace of mind. It ensures that the products they are using meet the high standards of quality that they expect and reinforces their loyalty to and trust in their preferred brands. Read More…
What Are the Benefits of ISO 22716 to My Business?
From the point of view of manufacturers, suppliers, retailers, or wholesalers, Cosmetic GMP also provides confidence. It ensures that products meet all of the applicable legal requirements and quality and safety standards. Ultimately, applying Cosmetics GMS protects brand reputation.
Business Benefits – Internal
- Integration of Quality GMP requirements
- Fosters Legal Compliance
- Controls and reduces Hazards
- Promotes Continues Improvement
Business Benefits – External
- Internationally Accepted
- Sales and Marketing Opportunities
- Improved Supply Chain Management.
What are the considerations when implementing ISO 22716?
You may wish to think about the following:
- Obtaining a copy of the ISO 22716 standard
- Review/Create your organization chart
- Think about the flow of materials/products through your organization
- Think about how you manage risk in your supply chain
- Think about what processes you have in place for maintaining plant and equipment
- Think about what methods you have in place in the event of a product defect/recall
- Arranging a Gao Analysis
- Engage in the services of a consultant to assist.
Compliance with GMPs
Compliance with Good Manufacturing Practices (GMP) for cosmetics is linked to compliance with the ISO standard 22716.
This compliance is verified through an internal audit or a specialized service provider that checks compliance with ISO 22716.
The ISO 22716 certifications are necessary for the marketing of cosmetic products. However, although it requires strict measures, there is no official certification for this standard.
Why should you choose the TUV Austria Bureau of Inspection & Certification?
Considering the benefits of implementing the ISO 22716 Standard and achieving accreditation, you may need to find a competent partner to help you get there. At TUV Austria Bureau of Inspection & Certification, experienced and dedicated ISO experts help you get accredited and not as much effort to attain and maintain. Over the years, we have served the industry and have been blessed with satisfied customers. This is due to the following:
- A skilled, well-trained team of ISO 22716 consultants
- Adequate, customized documentation that does not mean you have to change who you are (unless you want to, of course)
- Practical and time-saving processes to meet the requirements of the standard
- A thorough internal audit program
- Accreditation is good timing, including documentation and implementation activities.
In Addition, to ISO 22716:2007 audits we also offer a range of complimentary services:
- ISO 9001: 2015 Quality Management System
- ISO 28000:2007 Supply Chain Security Management System
- ISO 31000: 2018 Risk Management – Guidelines
- HACCP Food Management System
- ISO 22000: 2018 Food Safety Management System
- Food Safety System Certification (FSSC) 22000 V5
- IFS Certification
- QA/QC Services
- Process improvement solutions
The cosmetic regulation 1223/2009 states that the ISO 22716 certificate must be added to the product information File (PIF) of your cosmetic product.
However, there is no ISO 22716 Certification, so how do we meet this requirement?
ISO 22716: 2007 gives guidelines for the production, control, storage, and shipment of cosmetic products. The objective of these GMP guidelines is to define the activities that enable you to obtain a product that meets defined characteristics.
These guidelines have been prepared for consideration by the cosmetic industry and consider the specific needs of this sector. Good Manufacturing Practices constitute the practical development of the quality assurance concept by describing the plant activities based on sound scientific judgment and risk assessments.
What is GMP?
- Required by European Cosmetic Regulation
- Must Comply to sell product in Europe
- It is part of quality management and is a way of working to make sure that all products are:
- Consistently manufactured
- to a quality appropriate for the intended use.
What is ‘Fitness for Purpose’?
- Is safe
- Meets/Exceeds customer expectation
- Correct Product
- Correct Material
- Not deteriorated or broken down
- Is in the proper, correctly labelled container
- Is security sealed
- Free from contamination.
GMP – What could go wrong?
- Mix up of raw materials, bulk products, packaging & finished product
- Wrong quantity of ingredients added during making the bulk
- Contamination from people, equipment and the buildings in which we make cosmetics
- Risk of product deterioration from improper handling and transfer
- Risk in management of returned products.
What is the goal of GMP for cosmetic products?
- Good Manufacturing Practices for cosmetics described in the standard aim to;
- Validate the compliance of the business management system with the requirements for the European Cosmetics Regulation
- Ensure access to the European Market.