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?

Personnel

  • 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?

Storage

  • 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?

Quality Control

  • 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?

Complaints

  • 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

HELPFUL RESOURCES

The following documents will open up in a new page for you to save or print.

Best Practice Guide to Storage, Handling and Filling of Containers
Common Sense Hygiene Rules
Good Manufacturing Practice Cosmetics
Aromantic Challenge Test Results
Shelf Life of Aromantic Raw Materials
Aromantic-Organic-Certificate-Expires-April-2016