Overview of ISO 22716:2007 Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices
Safety is an important concern for cosmetic goods.
These are products that customers will put on their bodies and may contain ingredients that could potentially cause an allergic reaction. Therefore, it is crucial to ensure that these products are produced with non-hazardous ingredients and in a safe environment.
ISO 22716 is an international standard of good manufacturing practices (cGMP) for the cosmetics manufacturing industry and describes the basic principles of applying cGMP in a facility that produces finished cosmetic products. This guideline offers organised and practical advice on the management of human, technical and administrative factors affecting product quality.
Who Should Use ISO 22716?
- In Malaysia, similar to the EU responsible person, an organization is required to have a responsible person to notify the cosmetic products (known as the “Cosmetic Notification Holder” in Malaysia) to ensure the cosmetic products meet all stipulated regulations and guidelines for Cosmetics products. This person among things is to ensure organisations follow good manufacturing processes as laid out in ISO 22716 guidelines on good manufacturing practices.
- Any organisation involves in the cosmetic process, not only limited to production but also the control, storage, and transportation of products, including the purchase of raw materials, components and packaging material.
- If you want to ensure your production and specification of cosmetics result in products that are safe to use.
Why Should You Use ISO 22716?
- ISO 22716 helps you improve your brand image, facilitates your exports, and prepares you for inspections by the relevant authorities.
- Helps you ensure quality and safety compliance throughout every stage of the supply chain. This leads to a better final product which is produced at the highest standard and with customer safety in mind while ensuring a safe environment for employees.
- Improves your business’s reputation and also safeguards your products from potential issues such as contamination or a lack of quality control.
- You want to control of hazards and risks associated with cosmetic products.
- Reduces the potential hazards of your cosmetics manufacturing and promotes better manufacturing practices to protect your employees and also the environment.
- You want to ensure your processes are adhering to the regulatory and legislative requirements of Malaysia and relevant exporting countries. All cosmetics products distributed in the EU must be manufactured according to the Cosmetics Good Manufacturing Practices described in the ISO 22716 standard. Compliance with this standard can be demonstrated through an ISO 22716 certificate or by a declaration stating that the products are produced in accordance with ISO 22716. ISO 22716 enables your cosmetic products to enter the EU market.
- You want to enhance the image of the company in terms of the safe production of cosmetics.
- You want to demonstrate to your customers, suppliers and external stakeholders that you are committed to being a safety-conscious organisation, which can both drive sales growth and overcome regulatory barriers to entry for certain projects or businesses.
- Regulators and customers alike are increasingly demanding food safety be taken into account by the organisation they are purchasing from or working with. In the absence of a cGMP system, you risk losing customers to competitors that see the value in showing their customers they have a cGMP management system.
- Without an ISO 22716 cGMP, you may face the risks and lost opportunities and risk being known as an organization that doesn’t consider safety in your operations.
- You will potentially be eligible for more lucrative, large scale both government and private sector contracts that are only offered to organisations that can provide proof of their commitment to safety and who can meet their standards.
Requirements of ISO 22716
- Clause 3 Personnel
- Clause 4 Premises
- Clause 5 Equipment
- Clause 6 Raw materials and packaging materials
- Clause 7 Production
- Clause 8 Finished products
- Clause 9 Quality control laboratory
- Clause 10 Treatment of product that is out of specification
- Clause 11 Wastes
- Clause 12 Subcontracting
- Clause 13 Deviations
- Clause 14 Complaints and recalls
- Clause 15 Change control
- Clause 16 Internal audit
- Clause 17 Documentation
MLOK’s methodology and approach to making your company ISO 22716 complied for certification
We adopt four stages of the most practical and methodological process to help you certified for ISO 22716.
Stage 1: Planning
Conduct Kick-Off Meeting to:
- conduct Gap Analysis;
- establish implementation schedule and plan;
- appoint cGMP Committee;
- establish a documentation framework; and
- have a fundamental understanding of the requirements of ISO 22716.
Stage 2: Documentation
Food Production Factory Layout Design.
Drafting and writing documents to comply with ISO 22716 requirements:
- cGMP Manual;
- Job Description;
- cGMP Core Procedures;
- cGMP Supporting Process Procedures;
- cGMP System Procedures; and
- cGMP Forms, Work Instructions and others.
Stage 3: Implementation
- Guidance and advice on the implementation of the documented cGMP.
- To conduct ISO 22716 cGMP Internal Audit Training.
- To conduct an ISO 22716 cGMP Internal Audit.
- To conduct an ISO 22716 cGMP Management Review Meeting.
Stage 4: External Audit
- Stage 1 Documentation Audit by the Certification Body.
- Rectification of Stage 1 Audit Finding issued by the Certification Body.
- Stage 2 Audit Compliance Audit by the Certification Body.
- Rectification of Stage 2 NCRs issued by the Certification Body.
You will then receive your ISO 22716 certificate.
Malaysia
