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Technical Section

This section contains the MSDS sheets, Analysis sheets and more.  Plus information about our products and the cosmetic world.


GMP - what's it all about?

Monday, 2 January 2017 11:22

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!

Josie McCaffrey

Safety Assessors and CPSR

Monday, 2 January 2017 11:07

Looking to get your recipes/products assessed and a CPSR produced?  

Or for some help with product development?

We have contacted these companies who are able to help Just a Soap customers with getting their products to market.

Oxford Biosciences : telephone 01844 238827 or email: safety@oxfordbiosciences.com

Cosmetic Safety Consultants Ltd : telephone:  020 3239 1857 or email: Info@cosmeticsafetyassessment.com

Garrs Cosmetic Safety : telephone 01244 322101 or easily via email: info@garrscosmeticsafety.co.uk

If you are looking for Formulation Development  or Advice or Regulatory Support then Stacey Irvine at Global Cosmetic Developments will be able to help you.

PIF - what do I need to do?

Monday, 2 January 2017 11:16

So what is a PIF, why do I need one and how do I make it?

If you are selling your cosmetic products then one of the requirements is that you produce a Product Information File (PIF) for each recipe/product that you make.

It needs to be established before you start selling your products, as it is basically a record of how you made them.  Think of it like a big file that you just keep adding to.

It needs to be kept by the Responsible Person (typically the business owner/manufacturer) at an EU address and it can be electronic or any other format.  It needs to be easily accessible and should be kept for 10 years after the last batch of products has been made.

So what do you need to include in your PIF?

  • a description of your product - what is it?  an example would be a Strawberry Soap
  • the CPSR - the Cosmetic Product Safety Report.  This will be provided by the Safety Assessor and is made up of the Part A Safety Information, and part B the Safety Assessment.
  • How did you manufacture your product.  This will probably be the same each time and includes a description of what you did.  eg, I melted my clear soap base at xx deg C using a microwave/double boiler.  Once it had fully melted I added xx ml of named fragrance/essential oil etc etc.
  • evidence of following GMP - we have another section about GMP  which explains this fully.  But you need to be able to show that you have followed these principles.
  • have you made any claims about product?  are you saying it will banish wrinkles for example.  If you are  - then you need to prove it.
  • data on animal testing.  You will need to confirm that your products have not been tested on animals.  As Animal Testing on finished products and their respective ingredients has been banned in the EU since 2009 this should not be a problem.  Any supplier will be able to provide you with a statement confirming they do not test on animals.  Our statement can be downloaded here.

So you can record the data in a spreadsheet, in a document or a hand written book.  It is entirely your choice.  A spreadsheet is a good idea for recording the making of the product as you can accurately record quantities and amounts.

Remember it is a file that you will be constantly adding to.  Each batch of a product that you make needs to be documented and recorded. Why not start with a ring binder that you can put your pieces of paper in. Then you will know where everything is...

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