Interview Questions and Answers on IPQA
What is In process checks?
What are the check point during line clearance of granulation area?
- Logbooks
- Floor and walls
- Door and windows
- RMG, Multi-mill, FBD, Blender and Utensils
- All materials
Why granuation is important?
- To improve powder flow.
- To improve compressibility.
- To reduce fines.
- To control the tendency of powders to segregate.
- To control density.
- To capture and fuse small quantities of active Material.
What are the check point during line clearance of comression area?
- Logbooks
- Floor and walls
- Door and windows
- Temperature and humidity
- All parts of compression machine (hopper, turret, dies, ejection plate, punches etc.)
What are the in-process tests of tablet compression?
- Appearance
- Hardness and thickness
- Friability
- DT
- Weight Variation
What are the in-process tests of tablet coating?
- Appearance
- Weight Gain
What is the weight variation limits for tablet?
As per BP
- ± 10% for 80 mg or less
- ± 7.5% for 81 mg to 249 mg
- ± 5% for 250 mg or more
As per USP
- ± 10% for 130 mg or less
- ± 7.5% for 130 mg to 324 mg
- ± 5% for more than 324 mg
What is the weight variation limits for capsule?
- ± 10% for less than 300 mg
- ± 7.5% for more than 300 mg
What are the tablet friability test criteria?
- Rotation: 25 rpm or 100 rotations
- Tab weight: 6.5 g
- Limit: NMT 1.0%
What are the disintegration time (DT) for different types of tablets?
- Uncoated Tablet: NMT 15 min, in water with Disc
- Coated Tablet: NMT 30 min, in water with Disc for Film Coated Tab, and NMT 60 min Other than Film coated tablet
- Dispersible/Soluble Tablet: Within 3 min in water
What are the criteria of DT Apparatus?
- Mesh Size: 2mm (#10)
- Cycles: 28 – 32 cycles/min
- Temperature: 37 °C ± 2 °C
What is the Carr’s Index?
What is hausner ratio?
A simple method to measure powder flow properties.
Hausner ratio = Tapped density/Bulk density.
What are the common tablet problem during compression?
What is tablet capping?
It is partial or complete separation of the top or bottom of tablet due air entrapment in the granular material.
What is tablet lamination?
What is tablet sticking?
What is tablet picking problem?
How many Tablets shall be taken for checking friability?
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.
What is the formula for calculating weight loss during friability test?
%Weight loss = (Initial Weight – Final Weight)/ Initial Weight X 100.
Why do we check hardness during in process checks?
What are the factors which influence tablet hardness?
Which type of tablets are exempted from Disintegration testing?
What checks shall be carried out, while calibrating DT apparatus?
What is the difference between disintegration and dissolution?
What is the difference between calibration and validation?
Why 70% Isopropyl Alcohol is used as Disinfectant in Pharmaceuticals?
What is deviation?
What is the main difference between deviation and change control?
What is the difference between humidity and relative humidity?
- Humidity: Amount of moisture or water present in the air in the form of water vapour
- Relative humidity: Percentage of the moisture in the air at particular specific temperature.
Which factors contribute to quality products?
- Starting materials and packaging materials
- Validated processes
- Personnel
- Procedures
- Equipment
- Design and quality of premises
- Manufacturing environment
What can HVAC do?
- Control airborne particles, dust and micro-organisms
- Maintain room pressure
- Maintain relative humidity and temperature
What are consist of HVAC system?
- Air conditioning
- AHUs
- Dehumidifier/Heater
- Filter (pre/HEPA)
- Dust extractor
- Ducting
- Supply fan
- Smoke detector
- Damper
- Humidity/temperature/pressure sensor.
- Bag filter
- Heating/cooling coil
What is Protocol?
What is Qualification?
process is designed, installed, and operated properly. (Generally equipment is validated by installation qualification, operational qualification, systems by installation, operational and performance qualification. Process validation and Performance Qualification are often synonomously used).
What is Validation plan?
What is process validation?
What are the types of process validation?
- Prospective validation
- Concurrent validation
- Retrospective validation
- Revalidation
What is CAPA (Corrective and preventive action)?
What is Quality Policy?
What is Risk Assessment?
What is Cross-contamination?
What is Aseptic Processing Facility?
What do you mean by LOD and water content?
What is the difference between drug purity & potency?
- Purity: it is the absence of unwanted substances like impurities & contaminants
- Potency: it is a measure of drug activity measured in terms of amount of drug required to produce an effect