This article deals with GMP for cosmetic products. GMP for pharmaceutical products are different and not covered by this article.
GMP of cosmetic products in a nutshell
What is GMP?
Good Manufacturing Practices are practical and organizational guidelines set up to ensure the reproducibility and the quality of the manufacturing process of cosmetic products. It consists of a couple of measures that have to be implemented in relation to the manufacturing process, control, storage and shipment.
The goal of GMP for cosmetic products
Good Manufacturing Practices for cosmetics are described in the ISO 22716 standard and aim to:
- Validate the compliance of business management system with the requirements of the European Cosmetics Regulation
- Ensure access to the European market
Please note: Good Manufacturing Practices concern the quality of the cosmetic products. They don’t target the safety of the employees nor environmental protection.
Which Stakeholders are involved?
GMP concern all those involved in the manufacture, control and storage and shipment of cosmetic products such as finished product manufacturers, distributors and importers / exporters.
GMP and the Cosmetic Regulation No 1223/2009
Good Manufacturing Practices for cosmetic products are required by the European Regulation 1223/2009. Indeed, the Regulation refers to the ISO 22716 standard and requires to add a declaration of compliance associated to the manufacturing facility to the Product Information File (PIF).
Guidelines for the ISO 22716 standard for Good Manufacturing Practice
The ISO 22716 standard defines the quality and reproducibility of cosmetic products found on the European market. They must be GMP and Regulation 1223/2009 compliant.
EcoMundo summarizes here the different points of the ISO 22716 standard which describes the different measures to adopt to comply with Good Manufacturing Practices.
Please note: This a non-exhaustive list, to get all the necessary information, please refer to the official publication of ISO 22716 standard.
The company staff must belong to a clearly structured organization where every employee knows what responsibilities and activities he must do vis-à vis the process of production, control, storage and shipment of cosmetic products. Therefore it is necessary that the staff have appropriate training, documentation and skills for the manufacture of cosmetics.
The premises must allow to easily observe the following conditions;
- Ensure the product protection
- Be regularly cleaned / sanitized / maintained
- Minimize the risk of mix of product/ raw materials / Internal controls of all operational flows: materials / products etc.
The equipment used by the company must be designed to:
- Avoid contamination of the product (including shipping, for example a workshop to another)
- Facilitate cleaning / Maintenance / a regular calibration (including adequate space around, below and inside equipment)
4. Raw Materials and packaging items
The purchase of raw materials and packaging for cosmetic items depends on proper selection of suppliers made of specific quality criteria. The next step is to create a dynamic supplier chain of information so as to quickly trace problems that might arise. The reception and storage purchases depend on strict rules (verification, strict nomenclature, accurate labeling, etc.) and must be performed by qualified personnel. Regarding the water used in production, its quality must be ensured by a system of adequate treatment and testing.
Various measures should be taken during the manufacture of the cosmetic product to obtain a quality product. It is particularly necessary to:
- Summarize the process of producing the cosmetic product (raw materials, formula, and required equipment) in an accurate and comprehensive documentation
- Identify quality control points
- Number the batch and label them properly for an easy identification on the production line
- Check the cleanliness, safety and calibration of premises and equipment before producing to minimize the risk of product contamination
6. Finished Products
Finished products must meet the quality standards established by the company. Their quality must be maintained during storage operations, shipping and product returns.
Before placing the finished product on the market, it is necessary to verify the compliance with defined quality criteria.
Strict rules of storage must be put in place to differentiate the different batches, the returned batches and batches placed in quarantined. They are made possible by a specific product labeling.
7. Treatment of off-specification and deviations
The quality control will help to highlight the raw materials, finished products, and packaging items out of specification. The staff in charge of quality control will then treat these nonconformities by measures such as the destruction or recycling of finished products, rejection of raw materials and packaging items.
If a deviation to operation of the manufacture is established, this must be noted and justified. The deviation can lead to a decline in quality, a decision must be made for the placing on the market of the finished products. The competent staff will then take corrective action so this gap does not happen again.
The company must define the different types of waste generated by the production process and control of cosmetic products. These must be clearly identified and their disposal must be done in a controlled and sanitary manner: waste streams should not hamper the operations of production and control.
If outsourcing (for manufacturing, packaging, testing, cleaning and disinfection of premises, etc.), the company must develop a contract or agreement with the subcontractor which defines requirements to meet the acceptance criteria of the company, in accordance with the specificity of the manufactured cosmetics.
Just as the choice of supplier, the choice of the subcontractor is done according to specifications.
10. Complaints and recalls
All claims must be investigated with the following elements:
- The preventive measures against the recurrence of the default
- The verification of all concerned batches
Processes concerning recall operations should allow a fast operation by authorized personnel. If the recall is likely to have an impact on consumer safety, the authorities concerned must be informed and the recalled products should be identified and stored separately pending a decision.
In the case of outsourced operations, the contract between the prime contractor and the subcontractor must agree on a process.
11. Change Management
Changes affecting the quality of the product must be approved and performed by authorized personnel on adequate database.
12. Internal Audit and Quality Service
To ensure the implementation and enforcement of GMP, companies must implement internal audits. These must be led by the company's quality service. The audit team is in charge of setting up and verifying that all guidelines outlined in the ISO 22716 standard are correctly implemented. Moreover, in case of non-compliance, they are responsible for analyzing deviations in order to find appropriate corrective measures.
Note: no external audit performed by a third-party is mandatory.
Companies should put in place an updated documentation system to identify activities related to the production, control, storage and shipment of cosmetic products. It can be protocols, instructions, methods, etc.
The documentation must be accessible, signed, dated and updated regularly.
How to comply with GMP?
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 by using a specialized service provider that checks compliance with ISO 22716.
Important: The ISO 22716 certification is necessary for the marketing of cosmetic products. Although it requires the implementation of strict measures, there is no official certification for this standard.
The Cosmetic Regulation 1223/2009 states that the ISO 22716 certificate is to be added to the Product Information File (PIF) of your cosmetic product.
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