1.
State what is meant by GLP.
[1 mark]
- Good Laboratory Practice
JD SCIENCE
Good scientific and clinical practice
Indicative marking points. Award marks for equivalent scientific or mathematical wording. Do not issue this sheet with the student worksheet.
2.
State what is meant by GMP.
[1 mark]
- Good Manufacturing Practice
3.
State what is meant by an SOP.
[1 mark]
- standard operating procedure
4.
State what is meant by validation.
[1 mark]
- showing a method is fit for purpose
5.
State what is meant by verification.
[1 mark]
- checking a validated method still works in this lab
6.
State what is meant by calibration.
[1 mark]
- adjusting or checking an instrument against standards
7.
State what is meant by a blank.
[1 mark]
- sample without the analyte
8.
State what is meant by a QC sample.
[1 mark]
- sample of known value run with the batch
9.
State what is meant by aseptic technique.
[1 mark]
- working to prevent contamination
10.
State what is meant by reflective practice.
[1 mark]
- reviewing what went well and what to improve
11.
Noah is asked about GLP in a NCFE Science paper.
(a) [2 marks]
- quality system for non-clinical studies
(b) [3 marks]
- SOPs, training, archives
12.
Noah is asked about GMP in a NCFE Science paper.
(a) [2 marks]
- quality of medicines and products
(b) [3 marks]
- prevents contamination and mix-ups
13.
Noah is asked about an SOP in a NCFE Science paper.
(a) [2 marks]
- step-by-step controlled method
(b) [3 marks]
- must be the current version
14.
Noah is asked about validation in a NCFE Science paper.
(a) [2 marks]
- accuracy, precision, range
(b) [3 marks]
- done before routine use
15.
Noah is asked about verification in a NCFE Science paper.
(a) [2 marks]
- often with a QC sample
(b) [3 marks]
- after a new instrument
16.
Noah is asked about calibration in a NCFE Science paper.
(a) [2 marks]
- balance, pH meter, pipette
(b) [3 marks]
- record the certificate
17.
A balance reads 0.002 g with nothing on it. What should you do first?
[3 marks]
- Final answer: tare / zero and record the zero error
18.
A pipette is 0.8% high on a 10.00 cm³ check. Absolute error?
[3 marks]
- Final answer: 0.080 cm³
19.
QC mean is 5.00, result is 5.30. Percentage difference?
[3 marks]
- Final answer: 6%
20.
Three QC points: 4.9, 5.0, 5.1. Mean?
[3 marks]
- Final answer: 5.0
21.
An SOP review is every 24 months. Reviews in 6 years?
[3 marks]
- Final answer: 3
22.
A waterbath is 37.0 ± 0.5 °C. Is 36.4 °C in spec?
[3 marks]
- Final answer: yes (on the lower limit)
23.
Noah carries out a T-Level occupational task on good scientific and clinical practice. This is a typical NCFE required-practical style question.
(a) [2 marks]
- Independent: the factor being investigated
- Dependent: the measured result or quality check
(b) [2 marks]
- follow the SOP and keep other variables constant
- so the test is fair / only one variable is changed
(c) [2 marks]
- not recording the batch/lot number or operator ID
24.
Noah carries out writing or following an SOP for good scientific and clinical practice. This is a typical NCFE required-practical style question.
(a) [2 marks]
- Independent: a step in the method
- Dependent: whether the acceptance criteria are met
(b) [2 marks]
- same calibrated instrument
- so the test is fair / only one variable is changed
(c) [2 marks]
- skipping a verification check
25.
Noah carries out a COSHH / risk-assessment review for good scientific and clinical practice. This is a typical NCFE required-practical style question.
(a) [2 marks]
- Independent: hazard
- Dependent: control measure effectiveness
(b) [2 marks]
- same PPE and waste route
- so the test is fair / only one variable is changed
(c) [2 marks]
- using expired reagents or the wrong waste stream
26.
Noah carries out data review in a LIMS or quality log for good scientific and clinical practice. This is a typical NCFE required-practical style question.
(a) [2 marks]
- Independent: sample ID
- Dependent: result vs specification
(b) [2 marks]
- same calculation method
- so the test is fair / only one variable is changed
(c) [2 marks]
- transcription error between the instrument and the LIMS
27.
Compare GLP with validation.
[4 marks]
- Good Laboratory Practice
- showing a method is fit for purpose
- state one workplace implication
28.
Compare GMP with verification.
[4 marks]
- Good Manufacturing Practice
- checking a validated method still works in this lab
- state one workplace implication
29.
Compare an SOP with calibration.
[4 marks]
- standard operating procedure
- adjusting or checking an instrument against standards
- state one workplace implication
30.
Compare validation with a blank.
[4 marks]
- showing a method is fit for purpose
- sample without the analyte
- state one workplace implication
31.
Apply your knowledge of a blank to this situation: detects contamination
[3 marks]
- detects contamination
32.
Apply your knowledge of a QC sample to this situation: Westgard / acceptance rules
[3 marks]
- Westgard / acceptance rules