ISO 22716:2007 – Good Manufacturing Practices (GMP)

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) 
• Education
• 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 

This protects any manufactured products, minimizes the risk of mixing up products, ingredients, and packaging materials, and keeps cleanliness to a high standard as part of the GMP process. 

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. 

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 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 products should also meet strict storage regulations on appropriate conditions. Finished product storage containers should list the product's:  

• Name  
• Batch number  
• Relevant storage conditions  
• Quantity  

Regular inventory checks confirm that products are being stored adequately. This will help them maintain the quality required during storage operations, shipping, and product returns. 

“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.  

For sampling and testing purposes, samples must be identifiable by their:  

• Name  
• Concentration  
• Expiration date  
• Opening date  
• Storage conditions  
• Name of the person who prepared them  

Companies should take sufficient sample sizes so that any local regulatory body can analyze them if necessary.

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.