Pharmaceutical Production Jobs Interview Questions & Answers
Questions and Answers
1) Define the tablet?
Ans) Tablet is a solid dosage form. It contains the Active pharmaceutical ingredient (API) along with the excipients.
2) Define API?
Ans) API, known as Active pharmaceutical Ingredient. It is the first and important ingredient in any drug formulation. It is a biologically active component responsible for the drug effect.
3) What is excipient and give any two examples with their use?
Ans) Excipient is an inactive or inert component of the drug formulation which is helpful for improving the tablet characteristics.
Examples: Diluents, useful for increasing the bulk volume of a tablet. Also used for improving the flow properties while compressing the tablet. Lubricants, useful for improving the flow properties while compressing the tablet.
4) Give the examples for diluents and lubricants?
Ans) Diluents- Mannitol, sorbitol, starch, lactose, sucrose etc.
Lubricants – Magnesium stearate, calcium stearate, stearic acid etc.
5) Name the tablet preparation methods?
Ans) Wet granulation, Dry granulation, Direct compression.
6) Explain the wet granulation, dry granulation and direct compression?
Ans) Wet granulation: It involves mixing, wet sieving, drying, dry screening and compression. API and excipients are mixed well, then binder solution/ granulation fluid added to form a wet mass, wet mass is screening through a suitable sieve, formed granules are dried. Dried granules are again screened through a sieve. It helps to break down the granule agglomerates to produce a compatible size for preparing the tablet. These same size granules blended and compressed.
Dry granulation: It involves mixing, slugging, screening and compression. API and Excipients are mixed well and particles are aggregated under high pressure for forming slugs. These slugs are screened to form uniform granules for compressing the tablets.
Direct compression: In this method, blend of API and Excipients are directly compressed to form tablets without changing physical nature of material itself.
7) Name any three tablet processing problems and explain it?
Ans) Mottling, Capping and lamination.
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.
8) What is the difference between picking and sticking?
Ans) 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.
9) Define capsule and how many types of capsules are available?
Ans) It is a solid dosage form. It contains API and excipients enclosed in a water soluble shell made up of gelatin. Two types of capsules are available. Hard gelatin and soft Gelatin capsules.
10) Explain about hard gelatin capsules?
Ans) It contains two parts called body and cap. Body, a long narrow section. Cap, a smaller wide portion, it fixes over the body.
11) What is the biggest and smallest capsule size?
Ans) The biggest capsule size -000 & smallest capsule size – 5.
12) Define parenterals?
Ans) Sterile dosage forms administered by injections thorough one more layers of the skin.
13) Explain about Water For Injection (WFI)?
Ans) Purified water without any pyrogen, prepared by distillation or reverse osmosis.
14) What is pyrogen?
Ans) They are the metabolic products of microorganisms produced from living or dead microorganisms.
15) Difference between water for injection (WFI) and sterile water for injection (SWFI)?
Ans) WFI – Purified water without any pyrogen
SWFI – Purified and sterile water without any pyrogen
16) Difference between ampule and vial?
Ans) Ampule is simple dose unit and Vial is multiple dose units.
17) Use of additives in the parenteral formulations?
Ans) Additives are used for increasing the stability of solutions.
18) Explain about different types of additives with examples?
Ans) Anti oxidants are used for preventing the auto oxidation of medicament/drug in the formulation. e.g.: Ascorbic acid, Butylated Hydroxy Anisole(BHA), Butylated Hydroxy Toulene(BHT)
Synergists: Enhances the activity of anti oxidants. e.g.: Citric acid, Citarconic acid, Phosphoric acid, Tartaric acid etc.
Preservatives- Helps to prevent the microbial growth in the formulation. e.g.: Benzalkonium chloride, phenyl mercuric acetate, Thiomersol.
19) Give examples of tonicity modifiers?
Ans) Sodium chloride, Dextrose.
20) Which colours used in parenteral formulations?
Ans) Colours will not be used in the parenteral formulations.
21) What Do You Mean By Dq, Iq, Oq, & Pq?
Answer: Design Qualification (DQ): documented verification that the proposed design of the facilities, equipment, or systems is suitable for the intended purpose.
Installation Qualification (IQ): documented verification that the equipment or systems are installed or modified & comply with the approved design of the manufacturer’s recommendations and/or user requirements.
Operational Qualification (OQ): documented verification that the equipment or systems are installed or modified & perform as intended throughout the anticipated operating ranges.
Performance Qualification (PQ): documented verification that the equipment and ancillary systems are connected & can perform effectively and reproducibly based on the approved process method and specifications.
22) Define Strip Package And Blister Package?
Answer: Strip packages have at least one sealed pocket of material with each pocket containing a single dose of the product. The package is made of two layers of film or laminate material. The nature and level of protection which is required by the contained product will affect the composition of these layers.
Blister packages are composed of a base layer, with cavities called blisters which contain the pharmaceutical product, and a lid. This lid is sealed to the base layer by heat, pressure or both. They are more rigid than strip packages and are not used for powders or semi-solids. In tropical areas blister packages with an additional aluminium membrane is used which provide greater protection against high humidity.