01. Q. Which type of tablets are exempted from Disintegration testing?
A. Chewable Tablets
02. Q.What are the common variables in the manufacturing of tablets?
A.
· Particle size of the drug substance
· Bulk density of drug substance/excipients
· Powder load in the granulator
· Amount & concentration of binder
· Mixer speed & mixing timings
· Granulation moisture content
· Milling conditions
· Lubricant blending times
· Tablet Hardness
· Coating solution spray rate
A.
· Particle size of the drug substance
· Bulk density of drug substance/excipients
· Powder load in the granulator
· Amount & concentration of binder
· Mixer speed & mixing timings
· Granulation moisture content
· Milling conditions
· Lubricant blending times
· Tablet Hardness
· Coating solution spray rate
03. Q. Whether bracketing & validation concept can be applied in process validation?
A.
A.
Both Matrixing & Bracketing’s can be applied in validation studies.
Matrixing
Different strength of the same product
Different size of the same equipment
Bracketing – Evaluating extremes
Largest and smallest fill volumes
Fastest and slowest operating speeds
Matrixing
Different strength of the same product
Different size of the same equipment
Bracketing – Evaluating extremes
Largest and smallest fill volumes
Fastest and slowest operating speeds
04. Q. What is the difference between calibration and Validation?
A. Calibration is a demonstration that, a particular Instrument or device produces results within specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements. Whereas Validation is a documented program that provides a high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
A. Calibration is a demonstration that, a particular Instrument or device produces results within specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements. Whereas Validation is a documented program that provides a high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
05. Q. WHAT ARE GOOD MANUFACTURING PRACTICES (GMP)?
A. Good Manufacturing Practices are a set of regulations, codes, and guidelines for the manufacture of: Drug substances and drug products, Medical devices, In vivo and in vitro diagnostic products, Foods
The term “cGMP” is used by the federal government as current good manufacturing practices. By definition, “cGMP” indicates that the current GMP – which is “state of the art” – can change. “GMP” and “cGMP” are often used interchangeably and essentially they have the same meaning.
06. Q. WHO ENFORCES GOOD MANUFACTURING PRACTICES (GMP)?
A. Good Manufacturing Practices are enforced in the United States by the FDA (Food and Drug Administration)
Good Manufacturing Practices are enforced in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency (MHRA)
Good Manufacturing Practices are enforced in Australia by the Therapeutical Goods Administration (TGA)
Good Manufacturing Practices are enforced in India by the Ministry of Health, multinational and/or foreign enterprises and those individuals in the following positions:
Each of the inspectorates carry out routine GMP inspections to ensure that drug products are produced safely and correctly.
07.Q.LIST OUT THE APPEARANCE DEFECTS OF TABLES DURING COMPRESSION ACTIVITY?
8. Q What is the standard number of rotations used for friability test?
A. 100 rotations
10. Q Which capsule is bigger in size – size ‘0’ or size ‘1’?
A. ‘0’ size
11. Define process flow of API manufacturing?
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.
Laminating:- ‘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.
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.
8. Q What is the standard number of rotations used for friability test?
A. 100 rotations
9. Q What is the fall height of the tablets in the friabilator during friability testing?
A. 6 inches.Tablets falls from 6 inches height in each turn within the apparatus.
A. 6 inches.Tablets falls from 6 inches height in each turn within the apparatus.
10. Q Which capsule is bigger in size – size ‘0’ or size ‘1’?
A. ‘0’ size
11. Define process flow of API manufacturing?
12. Define process flow of Tablet manufacturing?
13. Define process flow of Sterile Lyophilized manufacturing?
14. Define process flow of Biotech product manufacturing?
15. Define Troubleshooting approach for problems related to particulate matter:
16. Preformulation research involves pharmaceutical and analytical investigations that both precede and support formulation development efforts for all dosage forms, please provide some example:
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