Quality Assurance

Question 1

what is the membrane filtration sterility test

Answer 1

used for products with anti-microbial agent or if the drug has antimicrobial properties if the product could pass through the filter
product filtered through, filter washed and then incubated

Question 2

what is the direct inoculation method of sterility testing

Answer 2

sample product transferred to media and incubated, anti-microbials neutralised, shake, may need to plate out if product is turbid
used for surgical sutures, suspensions, topical creams/ointments

Question 3

how is the medium chosen for sterility testing

Answer 3

must support growth of likely contaminants

promote recovery of damaged survivors

Question 4

what are sterilisation considerations

Answer 4

product fails sterility test if one containers shows microbial growth

Question 5

how to calculate acceptance of contamination

Answer 5

sample x percentage contaminated = percentage uncontaminated and accepted

Question 6

what is involved in QC

Answer 6

sampling, specifications, testing and release of products/materials

Question 7

what is involved in GMP

Answer 7

ensures product consistently produced and controlled to quality standards

Question 8

what does QA involve

Answer 8

all matters influencing quality of product

Question 9

what does GMP stand for

Answer 9

good manufacturing practice