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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
To view Aromantic's own GMP Declaration click here.

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