Basic IPQA Knowledge for beginner

     Question 1. How Many Tablets Shall Be Taken For Checking Friability?

Answer : 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.

     Question 2. What Is The Formula For Calculating Weight Loss During Friability Test?

Answer : %Weight loss =  Initial Weight - Final Weight  X 100Initial  Weight.

     Question 3. What Is The Pass Or Fail Criteria For Friability Test?

Answer : 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.

Question 4. What Is The Standard Number Of Rotations Used For Friability Test?

Answer : 100 rotations

       Question 5. What Is The Fall Height Of The Tablets In The Friabilator During Friability Testing?

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

Question 6. Why Do We Check Hardness During Inprocess Checks?

Answer : 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.

      Question 7. What Are The Factors Which Influence Tablet Hardness?

Answer :compression force, Binder quantity(More    binder more hardness) & Moisture content

        Question 8. Which Type Of Tablets Are Exempted From Disintegration Testing?

Answer :Chewable Tablets

       Question 9. Which Capsule Is Bigger In Size - Size '0' Or Size '1'?

Answer : '0' size

     Question 10. What Is The Recommended Temperature For Checking Dt Of A Dispersible Tablet?

Answer : 25 ±10C (IP) & 15 – 250C (BP)

    Question 11. What Is Mesh Aperture Of Dt Apparatus ?

Answer : 1.8 -2.2mm (#10)

    Question 12. List Out The Appearance Defects Of Tables During Compression Activity ?

Answer :Appearance Defects

1.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.

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

3.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.

4.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.

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

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

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

      Question 13. What Is The Pass/fail Criteria For Disintegration Test?

Answer : 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.

     Question 14. What Is The Recommended Storage Conditions For Empty Hard Gelatin Capsules?

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

    Question 15. Which Method Is Employed For Checking “uniformity Of Dosage Unit”?

Answer : 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.

     Question 16. What Is The Recommended Upward And Downward Movement Frequency Of A Basket-rack Assembly In A Dt Apparatus?

Answer : 28 – 32 cycles per minute.

     Question 17. What Needs To Be Checked During Inprocess Qa Checks?

Answer :

o    Environmental Monitoring

o    Measured values obtained from the process equipment  (ex:temperature,RPM etc.)

o    Measured values obtained from persons (ex:timmings,entries etc.)

o     Process attributes (Ex:weight,hardness,friability etc.)

    Question 18. What Precautions Shall Be Taken While Collecting Inprocess Samples 

Answer : While collecting inprocess samples, avoid contamination of the product being sampled (Don’t collect samples with bare hands) & avoid contamination of sample taken.

    Question 19. In A Tablet Manufacturing Facility ‘positive’ Pressure Is Maintained In Processing Area Or Service Corridors?

Answer : In tablet manufacturing facilities, pressure gradients are maintained to avoid cross contamination of products through air. Usually service corridors are maintained under positive pressure with respect to processing areas.

    Question 20. If Sticking Observed During Tablet Compression What May The Probable Reason For The Same?

Answer :

1    If the granules are not dried properly sticking can occur.

2    Too little or improper lubrication.

3    Too much binder

4    Hygroscopic granular

     Question 21. 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)

     Question 22. What Is The Difference Between Calibration And Validation?

Answer : In tablet manufacturing facilities, pressure gradients are maintained to avoid cross contamination of products through air. Usually processing areas are maintained under positive pressure with respect to service corridors.

     Question 23. What Is In Process Checks?

Answer : In process checks are  checks performed during an activity,In order to monitor and,if necessary,to adjust the process to ensure that product confirms to its specification.

    Question 24. 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).

    Question 25. 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.

     Question 26. 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.

1    First batch quality is accidental (co-incidental),

2    Second batch quality is regular (accidental),

3    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.

     Question 27. Position Of Oblong Tablets To Be Placed In Hardness Tester To Determine The Hardness? Lengthwise / Width wise?

Answer :Position of oblong tablets should be length wise because the probability of breakage is more in this position.