Mathematics and statistics Flashcards
How would you set up a stability programme for a tablet product?
Where would you find guidance bracketing and matrixing? Can you please explain what do they mean?
You have a tablet product that is printed with the product name on it. What maths and stats would you expect to see on the process?
What is an AQL?
QL stands for Acceptable Quality Level. It is a statistical quality control tool used to determine how many defective units are acceptable in a batch based on a predefined sampling plan.
AQL is widely applied in visual inspection and physical quality checks, especially for:
* Packaging (e.g. blister seal integrity, label alignment)
* Solid dosage forms (e.g. tablet colour, shape, coating defects)
The AQL defines the maximum number of non-conforming units allowed in a sample before the lot is rejected
What standards define AQL?
AQL is defined by ISO 2859
What standards define AQL?
You choose a sample size code based on batch size and (General) inspection level (typically Level II). (Special for small batch)
The standard then tells you:
* How many units to sample
* The maximum number of defects allowed for the batch to pass.
What is the significance of AQL, explain high level with respect to consumers and producers’ point of view. What are the criteria for selecting the defects.
What generic maths and stats in relation to assay?
Explain Cp and Cpk?
Explain linear regression?
Correlation coefficient?
You have a tablet product that is printed with the product name on it. What maths and stats would you expect to see on the process?
You’re getting periodic failures on your AQL sampling . What are you going to do about it? The failures are throughout the batch.
You are working in an OSD facility your QC lab report to you that your tablet hardness is out of control - what would be your strategy to assessing and controlling this statistically?
You receive a call from the laboratory to inform you that the hardness of tablet you prepare is out of control – can you detail what you would do to bring the process back into control using statistics.
a. Went through use of control charts
b. Pp and PpK then when in control Cp and CpK
c. Common and special cause variation
d. How monitor using SPC – outliers / rules for control charts
- Statistical Process Control
Question: Explain statistical process control and how control limits are defined.
odel Answer: SPC monitors process variability. Control limits = ±3 SD from mean (Shewhart chart).
Tips: CP/CPK > 1.33 desirable. Use CPK/PPK for capability vs performance. Use PPK for historical data (e.g., PQR).
