API Production interview questions and answers

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API Production interview questions

Define API?

Full form of API in pharma is Active pharmaceutical Ingredient. It is the primary and crucial ingredient in every drug formulation. This is the biologically active ingredient which is the reason for the drug’s effect.

Explain about Water For Injection (WFI)?

Water For Injection (WFI) is Purified water without any pyrogens made through distillation or reverse osmosis.

What is pyrogen?

Pyrogen are metabolic products produced by microorganisms that are produced by live or dead microorganisms.

Difference between water for injection (WFI) and sterile water for injection (SWFI)?

Water for injection (WFI) is Purified water without any pyrogen.

Sterile water for injection (SWFI) is Sterile purified water without any pyrogen.

Difference between ampule and vial?

Ampule is simple dose unit and Vial is multiple dose units.

what is use of additives in the parenteral formulations?

Additives are used for increasing the stability of solutions.

What are the different types of additives in the parenteral formulations with examples?

Antioxidants are used for protecting against auto oxidation of a drug or a medication within the formulation. e.g. For example: Ascorbic acid, Butylated Hydroxy Anisole(BHA), Butylated Hydroxy Toulene(BHT)

Synergists: Enhances activity of anti-oxidants. e.g. : Citric acid, Citarconic acid, Phosphoric acid, Tartaric acid etc.

Preservatives help to stop the growth of microbial organisms within the formulation. e.g. : Benzalkonium chloride, phenyl mercuric acetate, Thiomersol.

They are metabolic products produced by microorganisms that are produced by dead or living microorganisms.

what are the examples of tonicity modifiers?

Sodium chloride and Dextrose are tonicity modifiers.

Which colors used in parenteral formulations?

No any colors are used in the parenteral formulations.

What Do You Mean By DQ, IQ, OQ, and PQ?

Design Qualification (DQ) A documented proof that the design proposed for equipment, facilities, or systems are suitable to serve the intended purpose.

Installation Qualification (IQ) is a documented confirmation that the equipment or systems have been installed or modified in accordance with the design approved by the manufacturer’s specifications and/or specifications.

Operations Qualification (OQ) is a documented proof that the systems or equipment have been installed or modified, and function as planned for the expected operating ranges.

The Performance Qualification (PQ) A documented confirmation that equipment as well as other systems are properly connected and operate effectively and reliably in accordance with the approved method and the specifications.

FAQ : API Production interview questions