Manufacturing Flashcards
(12 cards)
What is Good Manufacturing Practice (GMP)?
It’s the minimum standard medicines manufacturers must meet to ensure high quality, appropriate use, and compliance with product specifications.
Are food supplements required to meet GMP standards?
No, supplements are unlicensed and are not legally required to meet GMP standards.
How are ‘whole food’ and ‘food form’ supplements regulated in the UK?
They are regulated as foods, not medicines.
What does ‘due diligence’ mean for UK supplement companies?
It’s the legal requirement that all products must be ‘fit for purpose’.
What’s the difference between GMP compliant and GMP approved?
GMP compliant means self-regulated to GMP standards; GMP approved means officially certified.
Which countries most often have GMP-approved supplement companies?
Australia (TGA) and the USA (FDA).
What do regulatory bodies test supplements for?
Heavy metals, solvent residues, aflatoxins, herbicides, and pesticides.
What contaminants are limited by UK and EU law in supplements?
UK: arsenic; EU: mercury, lead, cadmium.
What is a Certificate of Analysis?
A document showing test results for raw materials, batches, and end products, usually issued by independent assessors.
Why is cold pressing important for fish and omega plant oils?
It minimizes oxidation and maintains quality.
Why must whey protein be specially filtered?
To remove lactose, hormones, and other unwanted substances.
What is ‘overage’ in supplement manufacturing?
Adding extra ingredients so that the stated amount remains effective at the end of the product’s shelf life.
