COMPLYING WITH GMP
It is a requirement under Regulation EC 1223/2009 to produce your cosmetic products according to Good Manufacturing Practice. The law doesn’t require you to be GMP certified, only to demonstrate that you are complying with a recognised industry standard such as ISO 22716:2007. In order to do this it will be necessary to prepare full written GMP procedures for your business and include a GMP statement confirming compliance with the GMP standards in your PIF.
WHAT YOU NEED TO CONSIDER
Premises and equipment
- Are the premises maintained in good repair and are they suitable for cosmetic production?
- Is there adequate lighting and ventilation?
- Are tools and equipment suitable for the task and are they cleaned and maintained properly and checked for defects before use?
- What cleaning and pest control procedures are in place?
- What staff training is in place so that personnel understand their role and what they are required to do to comply with GMP?
- Are all personnel aware of the need to observe a high standard of personal hygiene and cleanliness and how is this achieved?
- Is appropriate protective clothing and equipment available and used?
Production Processes and Procedures
- Are there written procedures detailing the entire production process including any testing that needs to be carried out on products?
- Are ingredients weighed and measured correctly and how is this achieved?
- Are recipes followed correctly with no deviation from the formula or permitted ingredients outlined in the safety report?
- Are samples of each batch of product retained, stored, and protected from contamination?
- Are samples monitored and if relevant, tested again to ensure continued compliance with the product specification?
Documents and Records
- How is batch traceability achieved?
- Is there an efficient stock control system?
- Are all relevant documents completed and kept for the specified period of time?
- Are ingredients and products stored correctly according to their specific needs?
- Are all ingredients checked for quality prior to being used in a product?
- What procedures are in place to prevent contamination of ingredients and products?
- Are all stored containers labelled for easy identification of contents?
Packaging and Labelling
- What type of packaging is used and is it suitable for what it is being used for?
- How is waste packaging disposed of?
- What procedures are in place to deal with any defective packaging?
- Are products labelled correctly?
- What steps and procedures are in place to ensure that a consistent quality is maintained right through the production process
- What is the procedure if an ingredient or product is not of the required standard?
- What procedures are in place should there ever be a need to recall products?
- What procedures are in place to deal with complaints and adverse reactions?
- Are all complaints properly documented including action taken to resolve or settle any complaints?
A GMP policy document should also contain a GMP statement for example:
- The work area will be kept clean and tidy at all times
- No smoking, drinking or eating will be conducted during production
- Adequate ventilation will be maintained
- A high standard of personal hygiene will be observed
- Appropriate clothing, masks and gloves will be worn if there’s a risk from vapours or splashes
- Equipment will be checked for defects before and after use and if found to be defective will not be used until repaired or replaced
- All equipment (including electrical equipment) and tools will be used correctly and all safety precautions adhered to
- Product manufacture will only be carried out by suitably trained personnel
- Product manufacture will not be carried out by personnel suffering from an infectious condition until the infection has cleared
- Recipes will be followed with no deviation from the formula or permitted ingredients outlined in the Cosmetic Product Safety Report
- All ingredients will be measured and weighed accurately
- All ingredients and products will be stored appropriately according to their needs
- All containers will be accurately labelled so that contents can be easily identified