GMP or Good Manufacturing Practices - what does it mean?
As of July 2013 and the EC Regulation 1223/2009 it is now mandatory that all cosmetics are produced with GMP (page 2 section 16).
This makes good sense for everyone as it means safe products, consistent products and so it's good business all round.
So what are the points that need to be covered? Is it just a case of working in a clean room? Most of the points are obvious and you probably do them anyway. But by documenting and recording everything below you will get into the habit of GMP without even thinking about it. We've highlighted the main topics and given you some pointers as to what you should be doing when compiling your GMP procedures and keeping your records.
Personnel
- Who will make the products.
- how will they recognise the ingredients.
- have they been trained on what to do.
Premises
- are you working in a clean area.
- is it in a good state of repair.
- are you able to prevent the risk of cross contamination.
Equipment
- is the equipment easy to clean.
- is it suitable for purpose.
Raw Materials & Packaging
- where do you store the raw materials.
- how do you rotate the stock.
- how are the raw materials stored.
Production
- how do you make the product.
- what order are the ingredients added in - does this matter?
- are there any temperature controls needed
Finished Products
- what should the finished product look like.
- does it meet the defined acceptance criteria.
- is it consistent.
Quality Control
- Is there a procedure in place for quality control.
- what happens when things go wrong.
- what happens if the incorrect ingredient is added.
Treatment of Products out of Specification
- what do you do when something goes wrong.
- have you changed supplier or ingredient.
- any changes should be controlled and documented.
Waste
- what is your process for handling the waste.
- do you follow local guidelines.
Outsourcing and Sub Contracting
- do you have a written agreement with the third party.
- how are you checking the third party is working according to your requirements.
- do you regularly audit the third party.
Deviation
- do you have a process to cope with deviation - what happens when a product hasn't turned out quite how expected.What do you do.
- did you use different equipment.
- any changes must be controlled and documented.
Complaints & Recalls
- what do you do when someone says they don't like your product.
- what is your process for handling and investigating complaints.
- do you need to do a recall - what process do you have in place for this.
Change Control
- remember to document any changes you make to the manufacturing process.
- have you changed supplier for example.
Internal Audit
- you should have a process to continually monitor performance. Manufacture is an ongoing process and standards need to be maintained all the time. This means you will get a consistent product.
Documentation
- make sure you record what you do.
- document everything!
