Quality Assurance Flashcards
what made us do ‘good manufacturing practice’?
dextrose 5% drip feed solution BP -> non sterile + resulted in death of 5 patients
describe the devonport incident?
6th April 1971 - Evans medical manufactured 5% sterile dextrose sol
may 1971 - lot D1192/C distributed
29th feb 1972 - 2 deaths at hospital
1st march 1972 - 2 further deaths
2nd march 1972 - 1 further death
6th march 1972 - investigation begins
12th July 1972 - clothier report issued
what had happened in the company?
faulty temp recorders used in drains of autoclave
had debris in drain
recommended to run autoclave for 40 mins at max temp
list the serious faults leading to the incident?
- negligence to repair and investigate
- didn’t identify
- batches rel prod stadd
- selection of samples for sterility + pyrogen test by production staff = without adequate procedure/training
- samples taken from layer of bottles near dial —> problem not detected
what were the findings of the clothier report?
- lack instrument calibration
- lack maintenance activities + maintenance logs
- lack of operational procedures
- inadequate equipment
- inadequate equipment cleaning
- poor staff training
- no batch records review
what were the effects of the clothier report?
- ensure critical instruments = functional + calibrated regularly
- prove SOPs = accurate
- prove operators = traned
- test to see process works again + again
- document this had been done
4 main factors within GMP?
- planning
- documentation
- equipment + facility
- quality control
what are the basic requirements of GMP?
- manufacturing process (reviewed + consistently manufactured to needed quality + complying with specifications)
- facilities provided = qualified + trained personnel
- instructions + procedures written in clear + unambiguous language
- operators = trained
- records made
- distribution of product minimises risk to quality + takes account of good distribution practice
- complains = examined
what is qualified person?
responsible for rel products onto market/ for clinical trials
assures prod prepared according to all relevant requirements - inc GMP + meet specifications
must = registered (pharmacist, chemist, biologist)
what is the objective of quality control?
defined process, when followed, will yield product complying with its specifications
quality control product
- has correct ingredients with correct qualitative + quantitative compositions
- correctly processed
- is of purity needed
- = enclosed in proper container which bears correct label
- stored, distributed + subsequently handled —> quality maintained through expected shelf life
what is quality assurance?
total sum of organised arrangements made with object of ensuring that medicinal products = of quality needed by intended use
