Supplements in practice - Manufacturing

Question 1

Good manufacturing practice (GMP)

Answer 1

• Good manufacturing practice (GMP) is the minimum standard that a medicines’ manufacturer must meet in its production processes. Products must:
  o Be of consistent high quality.
  o Be appropriate to their intended use.
  o Meet the requirements of the marketing authorisation (MA) or product specification.
• The MHRA requires licensed medicines and herbal medicines to have GMP certification. As supplements are unlicensed they do not have to meet the requirements of GMP.
• ‘Whole food’ and ‘food form’ supplements are regulated as foods.

Question 2

GMP compliant vs GMP approved

Answer 2

• In the UK, supplement companies are required to manufacture with ‘due diligence’. There is a legal requirement that all products must be ‘fit for purpose’.
• Many companies are GMP compliant (self-regulated) but not GMP approved. This means that supplements may be produced to GMP standard with rigorous quality control, production and distribution procedures but without having actual GMP approval.
• Few companies in the UK are GMP approved —most of these are Australian or American companies as they have to meet the standards set by the Therapeutics Goods Act (TGA) or Food and Drug Administration (FDA) in their respective countries.

Question 3

Testing of contaminants

Answer 3

• Independent testing, or tests carried out by the regulatory agencies (Trading Standards or the Ports Authority), check for high or unacceptable levels of heavy metals, solvent residue, aflatoxins, or herbicides and pesticides in supplements.
• UK law limits contaminants such as arsenic; EU legislation limits amounts of materials such as mercury, lead and cadmium.
• GMP-compliant companies will test the raw material, batches and the end products to obtain a certificate of analysis for their products by independent assessors.

Question 4

Processing

Answer 4

The way certain ingredients are processed affects their quality:
* Fish oil and omega plant oils need to be cold-pressed to minimise oxidation; whey protein needs to be specially filtered to remove lactose, hormones, etc.
* Cheaper extraction and processing methods reduce the effectiveness of the supplement and affects its safety profile.
* Good supplement companies will be happy to advise on the manufacturing procedures they use. Ask them!
* Ingredients may degrade over a supplement’s shelf life. Reputable supplement companies will add extra so that the amount left at the end of its shelf life still meets the label claim. This is called overage.