Pharma interview questions for formulation production jobs

Pharma interview questions for production jobs discussed in this post. Production department present in formulation plant as well as bulk(api) plant. Formulation production jobs offered for b pharmacy fresher’s. By keeping them in mind this information produced. Here we have not discussed any questions from HR point of view. These are all technical questions for production job aspirants.

Reputed pharma companies conduct a qualifying exam for selecting candidate for the interview. Qualifying exam tests your basic knowledge regarding the pharmacy subjects. It may include questions for any subject. It do not have particular pattern, it’s purely a pharma company choice. These question and answers helpful to you for succeeding the interview. Pharma interview questions for production jobs are given below. Click here to see the pharma interview exam for for freshers before selecting the interview.

Pharma interview questions

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. 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) Inactive or inert component of the drug formulation, 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.

Also read: Clinical trials overview

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, Localised portion missing on the surface of the tablet.

Sticking- Adhesion of tablet localised 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) 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) 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- simple dose unit. Vial- Multiple dose unit.

17) Use of  additives in the parenteral formulations?

Ans) Additives used for increasing the stability of solutions.

18) Explain about different types of additives with examples?

Ans) Anti oxidants – 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 the 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.

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Quality assurance interview questions in pharma industry

Quality assurance interview questions in the pharma industry:

Before knowing the interview questions for  QA job, you have to know the situation in interview pattern. Here we have provided the question and answers according to Quality assurance department point of view. But in actual times there is no rule to ask these type of questions only. Because you are a fresher and you have all the subjects in your B pharmacy like pharmaceutical analysis, pharmaceutics and medicinal chemistry etc.

They may expect answers form you for other HPLC, UV  etc principles methodology also.  For your understanding about QA job and knowledge required for this job, we have provided QA job oriented knowledge related questions here.

You have to know the Quality control interview questions also before attending an interview for getting success.

Quality assurance interview questions in pharma industry are as follows

1. Define quality assurance

Ans) QA is a broad range of concept contains all the matters that individually or collectively effect the quality of a product. QA mainly concentrated on planning and documenting the procedures to assure the quality of the product.

2. Explain the difference between QC and QA?

Ans) QA provides the confidence that a product will full fill the quality requirements. QC determines and measures the product quality level.

3. Expand cGMP and what is the difference between GMP and cGMP?

Ans) cGMP known as Current Good Manufacturing Practices. It is a USFDA regulations to assure proper design , manufacturing and control of manufacturing processes and services.

GMP-Good Manufacturing Practices. These are the standard guidelines given by Food and Drug administration to make sure that a product is manufactured with safety and quality. c in  cGMP  means current. It refers to recent and advance updates to these standard guidelines. cGMP is up to date standard reference guidelines.

4) Tell me any five countries with their regulatory authorities?

Ans) India – Central Drugs Standard Control Organisation (CDSCO)

USA – United States Food and Drug Administation (USFDA)

UK – Medicines and Healthcare products Regulatory Agency (MHRA)

Japan- Ministry of Health Labour and Welfare (MHLW)

Australia- Therapeutics Goods Administration (TGA)

Brazil- ANVISA

5) Expand ICH? Tell me about ICH Guidelines?

ICH known as The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. It brings the regulatory authorities and pharmaceutical companies together to discuss the drug registration technical aspects.

The aim of the ICH is to enhance the harmonisation world wide to make sure that  safe, high quality and effective drugs are developed and registered in the most efficient manner.

ICH provides guidelines on 4 aspects that is quality , safety , Efficacy and Multidisciplinary guidelines.

6) What is SOP?

SOP known as Standard Operating Procedure.

7)Expand IQ OQ PQ DQ

IQ- Installation Qualification

OQ-Operational Qualification

PQ-Performance Qualification

DQ-Design Qualification

8) Difference between validation and calibration

Validation produces the documented evidence assuring a specific procedure/procedure or activity consistently develops a product with predetermined specifications and quality credits. It is performed according to validation protocol.

Calibration denotes that an equipment produces the values in specified limits by comparing the values produced by a standard. It is done according the calibration standard operating procedure.

9) Expand BMR and BPR?

Ans) BMR – Batch Manufacturing Record , is prepared as a written file during the manufacturing a product  by writing. Step by step manufacturing process and details about batch recorded here.

BPR Batch Packaging Record, is kept for every BMR. BPR is depends on packaging operation.

10) What do you know about stability studies?

Ans) These are necessary for developing the pharmaceutical products. It helps to evaluate the effect of environmental factors (e.g Light, Humidity, Temperature etc) on Active Pharmaceutical Ingredient(API) or Pharmaceutical formulation.

11) What is the time period required for long term and accelerated stability studies?

Ans) Long term 12 months, Accelerated studies- 6 months

12) What are types of climatic zones? India belongs to which climatic zone?

Ans) India belongs to Zone III(Hot dry zone) and Zone IVb(Hot/Higher humidity)

FYI

Quality assurance interview questions
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I have also prepared some more important questions for you from QA of point view. You can view QA interview questions in pharmaceutical industry here.

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