Pharmaceutical Production Interview Questions-Answers
Below are some Interview Questions and answers which can help the freshers as well as experience personnel for interview preparation so please Read and share if you think it useful.
1.What is Production :
All operations involved in the preparation of a pharmaceutical product, from receipt of raw materials through the completion of a finished product i.e from Raw material Receipt to Finished product dispatch. It also includes the handling of manpower and recording the manufacturing and the packing activity performed.
Documentation that provides the history of a batch from the raw material dispensing stage to completion of the batch or lot which include Dispensing of raw material, Granulation, Blending Compression, Capsule Filling, Coating, Inspection and yield at different stages. It also includes the details of the activity performed by whom, checked by whom, at what time activity was performed, at what date activity was performed and signature of the personnel involved in the batch or activity.
3. What is Batch Packaging Record :
Documentation that provides the history of a batch from packaging material dispensing, Blister packing, Bottle packing, Jar packing, Dry syrup Filling, labeling, Carton packing and shipper packing up to Dispatch of a Batch or Lot.
It also includes the details of the activity performed by whom, checked by whom, at what time activity was performed, at what date activity was performed and signature of the personnel involved in the batch or activity.
4. Active Pharmaceutical Ingredient :
A substance or a bulk pharmaceutical chemical that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of the disease or to effect the structure or any function of the body of man or other animals.
5. What is Standard Operating Procedure (SOP):
It is an authorized written document which describes the step by step instructions requirements for performing operations or any activity and non-specific to any product, process or material. It provides detailed procedure about systems applicable to various operation e.g. Equipment’s / Instrument’s / System’s Operation / Cleaning / Maintenance etc.
Everybody working in organization has to follow the instruction which are written in SOP and perform their activities accordingly.
6. What is GMP and CGMP :
Good manufacturing practices (GMP) are the practices required in order to conform the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, pharmaceutical products, dietary supplements, and medical devices.
These guidelines provide minimum requirements that a manufacturer must meet or follow to assure that their products are consistently high in quality, from batch to batch, for their intended use.
CGMP is Current Good manufacturing practices (GMP) and we have to follow the current practices as there are the changes in regulations so always you have to follow the current practices so it is called current.
7. What are the In processes checks parameters during Tablet compression:
Appearance, Group weight, Individual weight variation, Uniformity of weight, Thickness, Diameter, Hardness, friability, Speed of machine, compaction force, die fill depth and Disintegration time.
8. What are the In processes checks parameters during Capsule Filling:
Appearance, Group weight of filled capsule, Individual weight of filled capsule, Net fill content of the powder, locking length and Disintegration time.
9. What are the In processes checks parameters during Tablet coating:
Appearance, Inlet temperature, out let temperature, pan RPM, Gun distance from tablet bed, spray rate, weight gain, Group weight of Coated tablets, Individual weight of Coated tablets, and Thickness.
10. What are the defects in Compressed tablets :
Picking, sticking, capping, laminating, weight variation, Broken, chipped, Rough Surface, Double compressed, Rough edges, Powdery, Incorrect Description, Black spot, Oil spot, Foreign Product and Debossing/ Embossing.
11. What are the defects in Capsules :
Empty, Cracked, Dented, Telescopic, Unlocked, Partially locked, Improper polishing, Powdery, Long or Short caps, Printing defects, Improper locking length and Weight variation.
12. What is Water For Injection (WFI) :
Water for injection It is the water of extra high quality without significant contamination and Water for injection is generally made by distillation or reverse osmosis.
13. What is Aerosol in Pharmaceuticals :
Aerosol is a pressurized dosage forms containing one or more therapeutic active ingredients which will produce a fine dispersion of liquid and/or solid materials in a gaseous medium during operation.
14. Tell about wet granulation :
It involves Sifting of API & Excipients, Wet mixing, drying, Sifting, Blending and then Blend shall be compressed or Filled in Capsule and then compressed tablets are coated with coating solution.
Sifting of API and Excipients through Sifter, Mixing of API & Excipients then addition of binder solution to form a wet mass in Fluid Bed Processor or Rapid Mixer Granulator, then dried the wet mass in Fluid Bed Processor or Fluid Bed dryer. Dried granules are again screened through a sieve which helps it to break down the granule then it should be lubricated or mixed in Blender. These same size Blend are then compressed or can be filled in capsule.
15. Tell about Dry granulation :
Dry granulation involves mixing, pre-mixing, milling, compression or Capsule Filling. API and Excipients are sifted, milled in roll compactor to product slugs then slug size is reduced in multi mill or Oscillating granulator. Then these granules are Mixed or lubricated in Blended and then blend shall be compressed in compression machine or can be filled in capsule filling machine to form tablets or capsules.
16. What is tablet :
Tablets is defined as the solid unit dosage form of medicines with suitable Excipients and prepared either by molding or by compression. It comprises a mixture of active substances and excipients, usually in powder form, pressed or compacted from a powder into a solid dose.
17. Name any four tablet processing problems :
Mottling, Capping, lamination, picking and sticking
Mottling– unequal colour distribution of a tablet.
Capping– Partial or complete separation of a tablet top or bottom crowns.
Lamination– Separation of tablets into two or more layers.
Picking– Because of adhesion to the punch faces, Localized portion missing on the surface of the tablet. Sticking– Adhesion of tablet localized portion to the punch faces resulting in rough and dull appearance.
18. What is Disintegration Test :
It is the time required for the Tablet / Capsule to break into particles, the disintegration test is a measure of the time required under a given set of conditions (Temperature) for a group of tablets/capsules to disintegrate into particles.
Cycle of shaft holding the tube basket limit is 29-32 cycles per minutes and distance covered by shaft basket is 50-60 mm and beaker temperature is 35 to 39 º C. Disintegration is to be Performed to determine whether tablets or capsules disintegrate within the prescribed time when placed in a liquid medium at the experimental conditions.
19. What are the Disintegration Time of tablets :
- Uncoated Tablet 15 min as per BP & 30 min as per USP
- Sugar Coated Tablet 60 min as per BP
- Film Coated Tablet 30 min as per BP
- Plain Coated Tablets DT in specific medium for 30 min as per USP
- Enteric Coated Tablets DT in simulated gastric fluid (0.1 M HCl) for 1 hr and then in simulated intestinal fluid (Phosphate buffer 6.8 pH) until disintegrate as per USP.
- Dispersible Tablets 3 min ( 15- 25º C ) as per BP.
- Effervescent Tablets 1 tablet in 200 mL water for 5 min ( 15- 25º C )
as per BP
- Buccal Tablets 4 hrs as per USP.
- Soluble Tablets 3 min ( 15- 25º C ) as per BP.
- Chewable Tablets are not require to comply with test
20. What is Disintegration Time of capsules :
- Gastro resistant capsule DT 2 hrs without disk in 0.1 M HCl and phosphate buffer pH 6.8 for further 60 min as per BP.
- Hard and Soft gelatin capsule DT 30 min as per BP & USP.