Que 1: Why do we check hardness during inprocess checks?
Answer: To determine the need for the pressure adjustments on the tableting machine. Hardness can affect the disintegration time. If the tablet is too hard, it may not disintegrate in the required period of time. And if tablet is too soft, it will not withstand handling and subsequent processing such as coating packing, etc.
Que 2: What are the factors which influence tablet hardness?
Answer:
1.compression force
2.Binder quantity(More binder more hardness)
3.Moisture content
Que 3: Which type of tablets are exempted from Disintegration testing?
Answer: Chewable Tablets
Que 4: Which capsule is bigger in size – size ‘0’ or size ‘1’?
Answer: ‘0’ size
Que 5: What checks shall be carried out, while calibrating DT apparatus?
Answer: While calibrating DT apparatus, following checks shall be performed.
1.) Number of strokes per minute (Limit:29-32 cycles/min)
2.) Temperature by probe & standard thermometer
(Limit: 37 ± 1 OC).
3). Distance travelled by basket (Limit:53 -57mm)
Que 6: What is In process checks?
Answer: In process checks arechecks performed during an activity,In order to monitor and,if necessary,to adjust the process to ensure that product confirms to its specification.
Que 7: What is the difference between disintegration and dissolution?
Answer: Disintegration is a disaggregation process, in which an oral dosage form falls apart in to smaller aggregates.(Disintegration time is the ‘break up’ time of a solid dosage form).
Where as dissolution is a process by which solid substance enters in the solvent to yield a solution.It is controlled by the affinity between the solid substance and the solvent. In other word disintegration is a subset of dissolution.
Que 8: Why do we calibrate a qualified equipment/instrument on definite intervals?
Answer: An equipment or instrument can ‘drift’ out of accuracy between the time of qualification and actual use.So it is recommended to calibrate and recalibrate the measuring devices and instruments on predetermined time intervals, to gain confidence on the accuracy of the data.
Que 9: Why do we consider three consecutive runs/batches for process validation? Why not two or four?
Answer: The number of batches produced in the validation exercise should be sufficient to allow the normal extent of variation and trends to be established and to provide sufficient data for evaluation and reproducibility.
· First batch quality is accidental (co-incidental),
· Second batch quality is regular (accidental),
· Third batch quality is validation(conformation).
In 2 batch we cannot assure the reproducibility of data,4 batches can be taken but the time and cost are involved.
Que 10: Position of oblong tablets to be placed in hardness tester to determine the hardness? Lengthwise / widthwise?
Answer: Position of oblong tablets should be length wise because the probability of breakage is more in this position.
You Can also Read:
Interview Questions and Answers for Pharmaceutical (Part 1)
Interview Questions and Answers for Pharmaceutical (Part 2)
Interview Questions and Answers for Pharmaceutical Part 3
