Q. What is the pass or fail criteria for friability test?

A. Generally the test is run for once.If any cracked,cleaved or

broken tablets present in the tablet sample after tumbling,the
tablets fails the test.If the results are doubtful,or weight loss is
greater than the targeted value,the test should be repeated
twice and the mean of the three tests determined.A mean
weight loss from the three samples of not more than 1.0% is
considered acceptable for most of the products.
Q. What is the standard number of rotations used for friability test?
A. 100 rotations
Q. What is the fall height of the tablets in the friabilator during friability
testing?
A. 6 inches.Tablets falls from 6 inches eight in each turn within
the apparatus.
Q. Why do we check hardness during inprocess checks?
A. To determine need for the pressure adjustments on the
tableting machine. Hardness can affect the disintegration
time.If 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.
Q. What are the factors which influence tablet hardness?
A. 1.compression force
2.Binder quantity(More binder more hardness)
3.Moisture content
Q. Which type of tablets are exempted from Disintegration testing?
A. Chewable Tablets
Q. Which capsule is bigger in size – size ‘0’ or size ‘1’?
A. ‘0’ size
Q. What is the recommended temperature for checking DT of a dispersible
tablet?
A. 25 ±10C (IP) & 15 – 250C (BP)
Q. What is mesh aperture of DT apparatus ?
A. 1.8 -2.2mm (#10)
Q. What is the pass/fail criteria for disintegration test?
A. If one or two tablets/capsules fails to disintegrate
completely, repeat the test on another 12 additional dosage
units. The requirement is meet if not fewer than 16 out of 18
tablets/capsules tested are disintegrated completely.
Q. What is the recommended storage conditions for empty hard gelatin
capsules?
A. 15 – 250C & 35 -55% RH
Q. Which method is employed for checking “Uniformity of dosage unit”?
A. A.)Content uniformity
B.) Weight Variation
Weight variation is applicable for following dosage forms;Hard
gelatin capsules,uncoated or film coated tablets,containing
25mg or more of a drug substance comprising 25% or more by
weight of dosage unit.
Q. What is the recommended upward and downward movement frequency
of a basket-rack assembly in a DT apparatus?
A. 28 – 32 cycles per minute.
Q. When performing the ‘uniformity of weight’ of the dosage unit, how
many tablet/capsule can deviate the established limit?
A. Not more than two of the individual weights can deviates
from the average weight by more than the percentage given in
the pharmacopeia,and none can deviates more than twice that
percentage.
Weight Variation limits for Tablets
IP/BP Limit USP 80 mg or less 10% 130mg or less More than
80mg
or Less than
250mg
7.5% 130mg to 324mg
250mg or more 5% More than 324mg
Weight Variation limits for Capsules
Q. What needs to be checked during inprocess QA checks?
A. a.) Environmental Monitoring
b.) Measured values obtained from the process equipment
(ex:temperature,RPM etc.)
c.) Measured values obtained from persons
(ex:timmings,entries etc.)
d.) Process attributes (Ex:weight,hardness,friability etc.)
Q. What precautions shall be taken while collecting inprocess samples ?
A. While collecting inprocess samples, avoid contamination of
the product being sampled (Don’t collect samples with bare
hands) & avoid contamination of sample taken.
Q. In a tablet manufacturing facility ‘positive’ pressure is maintained in
processing area or service corridors?
A. In tablet manufacturing facilities, pressure gradients are
maintained to avoid cross contamination of products through
air. Usually processing areas are maintained un