quality assurance + quality control Flashcards

1
Q

quality

A

fit for purpose

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2
Q

GMP

A

Rules and Guidance for Pharmaceutical Manufacturers and Distributors

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3
Q

Is quality assurance part of quality control?

A

no

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4
Q

quality assurance

A

sum total of organised arrangements made with object ensuring medicinal products are of quality required for intended use

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5
Q

What is the British Pharmacopoeia?

A

leading collection of standards for UK medicinal products + pharmaceutical substances. published annually

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6
Q

What is the aim of the British Pharmacopoeia?

A

to set standards for quality of medicines

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7
Q

Who uses the British Pharmacopoeia?

A

individuals + organisations involved in pharmaceutical research/development/manufacture/quality control/analysis

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8
Q

What information does the British Pharmacopoeia contain monographs for?

A

1) drug substances
2) excipients
3) licensed formulated products
4) traditional herbal medicinal products
5) homeopathic stock + mother tinctures
6) unlicensed formulations

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