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Flashcards in Quality assurance 1 Deck (11):

Why is quality important?

Doctors need a good quality of product for treatment
Pharmacists and pharmaceutical industry responsible for delivering good quality product
Quality comprises purity, safety, effectiveness and reliability


What are the four levels in the evolution of quality management?

Quality control
Quality assurance
Total quality management


What is detection?

The first two levels- inspection and quality control- are classified as detection methods
Effort is focused on after the event checking and trouble shooting
This is very reactive and inefficient


What is quality assurance?

Detection is not an effective way of finding and eliminating the root cause of a problem
Quality assurance is a shift in emphasis from detection to prevention of non-conformance


How is quality assurance achieved?

Advanced quality planning
Improving the design of the product
Process and services
Improving control over the process
Involving and motivating people
It concentrates on improved product, service and process design to stop non-conforming products or services being produced or delivered in the first place


What is total quality management?

Changing from a detection to prevention approach requires a new operating philosophy
A new management style where prevention is embedded into organisational policy and objectives
A new way of thinking
A cross functional team approach
A more sophisticated application of tools and techniques supported by more emphasis on people, process management, training development and greater focus on waste elimination


1848 Import Drugs Act

Mission: enforce purity and potency standards


1906 Pure Food and Drug Act

Prohibited interstate commerce of misbranded and adulterated foods and drugs
Allowed for seizure and criminal penalties
Enforced by division of chemistry


1938 Food, Drug and Cosmetic Act

Extended control to cosmetics and therapeutic devices
Required new drugs to be demonstrated as safe before marketing
Eliminated requirement to prove intent to defraud in drug misbranding cases
Provided standards and safe tolerances
Authorized factory inspections


1962 Kefauver-Harris amendments

Drug manufacturers were required to prove drug effectiveness and safety to FDA before marketing
Advertisements must show complete info on benefits and risks
Adverse effects must be reported to the FDA


Industrial Bio-test scandal

Industrial Bio-Test held contracts on 40% of all safety testing on products regulated by the FDA or EPA including drug, pesticide and food additive products
Massive fraud uncovered that included data falsification on an unprecedented scale