In process QA (IPQA) checks - interview questions & Answer

In process QA (IPQA) checks - interview questions & Answer

Q. How many Tablets shall be taken for checking friability?

Ans:For tablets with unit mass equal or less than 650 mg, take  sample of whole tablets corresponding to 6.5g.For tablets with unit mass more than 650mg,take a sample of 10 whole tablets.

Q. What is the formula for calculating weight loss during friability test?

Ans: %Weight loss =  Initial Weight - Final Weight  X 100

                                                Initial  Weight

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

Ans: 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 grater 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?

Ans: 100 rotations

In process QA (IPQA) checks - interview questions & Answer

Q. What is the fall height of the tablets in the friabilator during friability testing?

Ans: 6 inches.Tablets falls from 6 inches height in each turn within the apparatus.

Q. Why do we check hardness during inprocess checks?

Ans: 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?

Ans: 1.compression force

        2.Binder quantity(More binder more hardness)

        3.Moisture content

Q. Which type of tablets are exempted from Disintegration testing?

Ans: Chewable Tablets

Q. Which capsule is bigger in size - size '0' or size '1'?

Ans: '0' size

Q. What is the recommended temperature for checking DT of a dispersible tablet?

Ans: 25 ±10C (IP) & 15 – 250C (BP)

Q. What is mesh aperture of DT apparatus ?

Ans: 1.8 -2.2mm (#10)

Q. List out the appearance defects of tables during compression activity ?

Appearance Defects

Capping:- ‘Capping’ is the term used, when the upper or lower segment of the tablet separates horizontally, either partially or completely from the main body of a tablet and comes off as a cap, during ejection from the tablet press, or during subsequent handling.

Lamination / Laminating:- Definition: ‘Lamination’ is the separation of a tablet into two or more distinct horizontal layers.

Sticking/filming: ‘ Sticking’ refers to the tablet material adhering to the die wall. Filming is a slow form of sticking and is largely due to excess moisture in the granulation.

Cracking:-  Small fine cracks observed on the upper and lower center surface of the tablets, or very rarely on the side wall are referred to as cracks.

Chipping:- ‘ Chipping’ is defined as the breaking of tablet edges, while the tablet leaves the press or during subsequent handling and coating operation.

Mottling:‘ Mottling’ is the term used to describe an unequal distribution of colour on a tablet.

Double Impression: ‘ Double impression’ involves only those punches,which have a monogram or other engraving on them.

Q. What is the pass/fail criteria for disintegration test?

Ans: 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?

Ans: 15 - 250C & 35 -55% RH

Q. Which method is employed for checking “Uniformity of dosage unit”?

Ans: 

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?

Ans: 28 – 32 cycles per minute.

In process QA (IPQA) checks - interview questions & Answer