Que 1 What is dead leg?
Ans: A dead leg is defined as an area in a piping system where liquid can become stagnant and not be exchanged during flushing.
Que 2 What is the recommended bio burden limits of purified water & WFI?
Ans: Purified water has a recommended bioburden limit of 100 CFU/mL, and water for injection (WFI) has a recommended bio burden limit of 10 CFU/100 mL.
Que 3: What is significant changes in stability testing?
Ans:
A 5% change in assay for initial value.
Any degradation products exceeds its acceptance criterion.
Failure to meet acceptance criterion for appearance, physical attributes and functionality test.
Failure to meet acceptance criteria for dissolution for 12 units.
Que 4: If leak test fail during in process checks what needs to be done ?
Ans:
Immediately stop packing process and check for:
Sealing temperature
Verify for any possible changes like foil width,knurling etc.
Initiate incident and perform investigation to find the probable cause of failure and impacted product.
Check & quarantine the isolated quantity of packed goods from last passed inprocess.
Collect random samples & do retest.
Blisters from the leak test passed containers shall allow to go further and rest must be deblistered / defoiled accordingly.
Que 5 : Which type of tablets are exempted from Disintegration testing?
Ans: Chewable Tablets
Que 6: What are the common variables in the manufacturing of tablets?
Ans:
- Particle size of the drug substance
- Bulk density of drug substance/excipients
- Powder load in granulator
- Amount & concentration of binder
- Mixer speed & mixing timings
- Granulation moisture content
- Milling conditions
- Lubricant blending times
- Tablet hardness
- Coating solution spray rate
Que 7: What is the difference between calibration and Validation?
Ans:
Calibration: is a demonstration that, a particular Instrument or device produces results with in specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements.
Validation: is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
Que 8: Appearance Defects of Tablets During Compression Activity ?
Ans:
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.
Laminating: 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: is defined as the breaking of tablet edges, while the tablet leaves the press or during subsequent handling and coating operation.
Mottling: is the term used to describe an unequal distribution of color on a tablet.
Double Impression: involves only those punches, which have a monogram or other engraving on them.
Que 9: What is the standard number of rotations used for friability test?
Ans: 100 rotations
Que 10: 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.
