quality assurance + quality control Flashcards
quality
fit for purpose
GMP
Rules and Guidance for Pharmaceutical Manufacturers and Distributors
Is quality assurance part of quality control?
no
quality assurance
sum total of organised arrangements made with object ensuring medicinal products are of quality required for intended use
What is the British Pharmacopoeia?
leading collection of standards for UK medicinal products + pharmaceutical substances. published annually
What is the aim of the British Pharmacopoeia?
to set standards for quality of medicines
Who uses the British Pharmacopoeia?
individuals + organisations involved in pharmaceutical research/development/manufacture/quality control/analysis
What information does the British Pharmacopoeia contain monographs for?
1) drug substances
2) excipients
3) licensed formulated products
4) traditional herbal medicinal products
5) homeopathic stock + mother tinctures
6) unlicensed formulations