Good Manufacturing Practices (GMP) are essential for ensuring the quality and safety of cosmetic products. In the European Union (EU), cosmetics are regulated under the new EU Cosmetic Regulation (EC) No. 1223/2009. This regulation outlines the requirements for the manufacture, testing, and marketing of cosmetics, emphasizing the need for high standards of production to protect consumer health.
GMP refers to a set of guidelines and principles that provide a framework for the production of cosmetic products. The key objectives of GMP include:
- Safety: Ensuring that products are safe for human health.
- Quality: Maintaining consistent quality across batches.
- Compliance: Meeting regulatory requirements and standards.
GMP Guidelines for Cosmetics
Implementing industry standard GMPs according to ISO 22716:2007 requires considering the following GMP guidelines:
Personnel and premises
GMP guidelines for cosmetics personnel center around assuring that they contribute to safety and quality rather than compromising it. Cosmetics company employees should be adequately trained, experienced, and qualified to correctly produce, store, and control products to correct specifications. They should also have the necessary support to perform their tasks efficiently with good hygiene and cleanliness. This support may include: Full GMP training (personnel hygiene and health), Supervision, Safety equipment, Personal protective equipment (PPE), Educatio, Resources.
A cosmetics manufacturer’s premises should always meet the GMP specifications; providing a safe, hygienic environment that minimizes contamination risk. Amenities should put cleaning and maintenance protocols in place and allow for an adequate division of: Storage, Production, Quality control, Washing and sanitization, Toilet facilities, Any further supporting facilities.
Equipment, raw, and packaging materials
All equipment used must be suitable for its purpose and adequately cleaned, sanitized, and maintained to prevent air contamination such as dust or moisture. A core part of a company’s GMP procedure is not to use cosmetics manufacturing equipment for any other purpose. It should also be stored properly and calibrated periodically if needed. Equipment shouldn’t be made of any material that could interact with the ingredients, products, or cleaning agents. If broken or no longer suitable for use, GMP guidelines require companies to fix, replace, or dispose of equipment adequately and safely.
All ingredients, raw materials, and packaging materials should meet an acceptance criterion for quality assurance purposes. All raw materials should be well organized and correctly labeled along with packaging materials to prevent mix-up with any products. These labels must contain batch/lot information so that they can be traced at any point in the manufacturing process. GMP guidelines also require companies to carry out regular stock inventories and investigate any discrepancies.
Production
Measures should be taken at every step to make sure that the finished product meets its specifications. Appropriate documentation and records should be created to capture all aspects of the production process. The guideline recommends establishing standard operating procedures (SOPs) for all processes. An SOP is simply a clearly written instructional document that clarifies in detail how a specific production activity is conducted. This includes GMP for cosmetics guidelines, the new product formulation of the cosmetic product in percentages, and weight/volume. Also, a list of all the raw materials used including their batch number, quantities, manufacture method.
Finished products and quality control
Finished products must meet the quality standards established by the company and reflect good manufacturing practices. Before a finished product reaches the market, companies need to verify compliance with defined quality criteria. Finished product storage containers should list the product’s: Name, batch number, relevant storage conditions and nominal quantity. Regular inventory checks confirm that products are being stored adequately.
“Quality” refers to the stability of a cosmetic product, its preservation, and its overall function. Many of the required tests check that the quality of a product remains at a high standard. Any products containing water are at risk of microbial growth contamination. They will require sampled quality checks to ensure they remain stable and pass challenge tests.
Complaints and recalls
Any complaints or adverse events reported about a cosmetic product must be reviewed, investigated, and followed-up on. All complaints should be centrally recorded using a systematic complaint logging and review process. Complaint investigations should include steps that prevent a product defect from reoccurring and measures to better recognize potential issues with safety or quality. If a severe or high-risk safety or quality issue is suspected, a company must be capable of implementing a product recall quickly and efficiently. Again, relevant documentation should show a systematic plan of action to inform the appropriate authorities of the recall, which could impact consumer safety.