Quality assurance Lec-1 Flashcards
1
Q
What is quality
A
- Something that meets the standard
- Degree of excellence
- Fitness for use
2
Q
How do we measure quality
A
- Fitness for use- are they fit for the process that we want to put them through
3
Q
Measurement
A
- How would you measure these criteria
- What have you got?
- A specification
- A measurement of quality
- A method of determining fitness for use
4
Q
Cefuroxime specification- From BP
A
- Assay content
- Identification- correct labelling
- Acidity of solution
- Related substances- impurities
- Water content- absorb water
- Bacterial endotoxin limit- Bits of bacterial cell wall from sterilisation (pyrogenic effect)
- Plus general injection specification e.g. sterile
5
Q
Cefuroxime specification- In house
A
- Cost
- Labels- be able to easily distinguish labels, reduce error
- Pack size- Limited space in hospital ward
- Rate of dissolution-
- Stability in solution-
6
Q
End product testing- Sterility test
A
- How the standard sterility test can fail to detect a significant contamination level
- 20 Units are sampled from an industrial batch
- Take small proportion of the batch to determine the chance of whether the batch being sterile or not
- Still a chance for a poor batch to pass
7
Q
Limitations end product testing
A
- You can’t guarantee fault free products by end product testing alone
- The system of inspect, rework or scrap sub-standard material is outmoded
8
Q
There is another approach
A
- Control variables that determine the output so that you don’t produce defective material in the first place
- Quality Management And/Or
- Quality Assurance
9
Q
Definition of quality management
A
- Accountability for the successful implementation of a quality system
10
Q
Definition of quality system
A
- Formalised business practice that defines management rresponsibilities for organisational structure, processes, procedures and resources needed to fulfill product/ service requirements
- customer satisfaction, and continual improvement
11
Q
What is the main variable in production/Dispensing process we must control
A
- People
- Quality is about people not products
12
Q
Quality management concepts
A
- Quality is an organisation wide concept involving everyone
- Right first time everytime
- Defects are not free- someone makes them and gets paid for making them
- We strive for quality by perfecting the process rather than the conclusion. This enables us to build quality into products and services- which is preferable to the mere costly less effective methods of inspecting rejects out
- The aim must be to reduce as far as possible the amount of inspection or appraisal and increase the effort put into prevention
13
Q
Public knowledge
A
- Most people are well informed about retail products
- Test drive cars
- Taste food
- Take medicines on trust
- Ingredients can be very toxic
- They are meant to make you better
- Safety and efficacy can be significantly changed by formulation and process changes
- NB- digoxin particle size change in tablets lead to increased absorption and so toxicity
14
Q
Safety, efficacy and quality
A
- Quality of a pharmaceutical product is measured by it’s fitness for intended use
- Safely and efficacy are part of quality and are not separable
- Safety-
- Efficacy- Does it work as intended
- Quality- arguably the most important, as it has an effect on safety and efficacy
15
Q
Fitness for purpose
A
- Correct product (formula and method)
- Correct strength
- Free from contamination
- No deterioration
- Correct container
- Correct label
- Sealed container- protected from damage and contamination
