Interview questions for quality assurance in the pharmaceutical industry:
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| Pharma Interview Questions and Answers |
Q1-What do you know about change control?
- Changes which were made to materials or procedures or methods or equipment or software should be documented properly.
- These changes should be approved, validated and able to traceable. Change control deals and makes sure all these changes.
Q2-Explain about Bracketing and Matrixing study designs instability testing
- These are the study designs for stability testing. In a full study design, you have to test the samples of all the design factors at all time points. Bracketing and Matrixing have reduced study designs.
- When multiple design factors involved in a study, these are the best alternatives to full study design. If you use these designs, you need not test all the samples at all time points.
- These study designs mostly used when multiple design factors involved.
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- Bracketing: In this schedule, At all time points only extremes of certain study factor (like container fill & or container size or strength etc) samples tested.
- Bracketing supposes that tested extremes stability represents the stability of the intermediate level of that study factor.
- Matrixing: In this schedule, at a specific time point a selected subset of the total number of possible samples for all factor combinations would be tested.
- At a next or subsequent time point, all the factor combinations for another subset would be tested. Matrixing supposes that at a given time point, tested each subset stability represents all the samples stability.
- Before using this study designs, certain assumptions should be evaluated and justified.
- NOEL: No Observed Effect Level
- MACO: Maximum Allowable Carry Over
CAPA:
- Corrective Action and Preventive Action. It is an important part of the QMS (Quality Management System).
- Corrective actions planned to know the cause of the problems which were happened in the past and correct it.
- Preventive actions intended to prevent the problems that might happen in the future.
Q3-Explain about Out of Specification (OOS) results and Out Of Expectation (OOE) results?
- Out Of Specification (OOS) results: Analysed test result falling outside the predefined acceptance range or criteria made by company documentation or official compendia.
- Out Of Expectation (OOE) results: Although the Analysed test result falls within the specification, this result will fall outside the procedure expected variability.
Q4-Stress Testing:
- Also called as Forced degradation study, stress study. Forced degradation study intended to know the degradation products, it will help us further to know the molecule intrinsic stability, degradation pathways establishment and to validate the molecule stability procedures.
- Stress testing conducted at the conditions which are more severe than the accelerated study conditions. For a formal stability program, stress testing not considered as a requirement. It is a regulatory authority requirement.
Q5-What is the purpose/use(s) of stability testing?
- Stability testing confirms as to how the quality of study product changes with time.
- It finds out the study product shelf life, recommended storage conditions as well as container closure system suability. Also gives assurance to the patient regarding the stability of a drug product. Stability testing is a regulatory requirement also.
Q6-What are different types of stability studies along with their conditions?
Ans)
- Long-term stability studies: Storage conditions 25+20C, 60+5% RH and Minimum Period is 12 months
- Intermediate stability studies: Storage conditions 30+20C, 60+5% RH and Minimum Period is 6 months
- Accelerated stability studies: Storage conditions40+20C, 75+5% RH and Minimum Period is 6 months
Q7-What is Dead leg:
- Dead logs not allowed in water design systems. These are the stagnant areas with no water flow. It allows microbial contamination resulting in the surface colonization by forming biofilms. If a dead log present in any case, it should have a particular pipe diameter and velocity. In general agreement in industry, the dead log should not be more than the pipe diameter.
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- For e.g: If the pipe diameter is 5 cm, then the dead log should not be more than 10cm.
Q8-What is Cleaning validation:
- It is a documented evidence involves the approved cleaning procedure for eliminating the process equipment contaminants. It means the process equipment ready and can be used safely for preparing the next product without any previous contaminants.
- These contaminants may be chemical (previous product residues), microbial or Physical (Particulate matter) types. Different types of cleaning agents used in the cleaning validation like aqueous solvents (water, surfactants, acids or bases, etc) and organic solvents.
Q9-Validation master plan (VMP):
- It is a document describes the company's validation strategy and approach for establishing the performance adequacy. VMP includes all the details and time scales regarding the validation work to be performed.
- It provides a documented evidence assuring that a particular process produces a product with predetermined specifications and characteristics consistently.
Four types of process validation available.
- Prospective validation: Conducted before process implementation to assuring that process is performs as intended based on pre-planned plans.
- Concurrent validation: Conducted during the product routine production.
- Retrospective validation: Conducted on some products, those products which are already on the commercial market. The intention is to establish the long term compliance of that product.
- Re-validation: This is nothing but a repetition of validation. Conducted to assuring that the changes/modifications are done in equipment/process in according to the change control procedures. Those changes are not affecting the equipment/process and their produced products adversely.
Quality assurance interview questions in the pharma industry are as follows
Q11 Define quality assurance
- QA is a wide range of concept in which all matters that affect individual or collective quality of a product. QA is mainly focused on planning and documenting procedures to assure the quality of the product.
Q12. Explain the difference between QC and QA?
- QA provides the confidence that a product will full fill the quality requirements. QC determines and measures the product quality level.
Q13 Expand CGMP and what is the difference between GMP and cGMP?
- cGMP is known as Current Good Manufacturing Practice. It is a USFDA regulation to assure the design, manufacturing and control of appropriate processes, services.
- GMP-Good Manufacturing Practice These are the standard guidelines given by the Food and Drug Administration, which ensure that a product is manufactured with safety and quality. c in cgmp means the current. It refers to recent and up-to-date updates to these standard guidelines. The cGMP standard reference is up to date.
Q14) Tell me five countries with my regulatory authorities?
- India Central Drugs Standard Control Organization (CDSCO)
- United States United States Food and Drug Administration (USFDA)
- UK Medicines and Healthcare Products Regulatory Agency (MHRA)
- Japan- Ministry of Health and Welfare (MHLW)
- Australia- Therapeutic Goods Administration (TGA)
- Brazil-ANVISA
Q15) Expand ICH? Tell me about ICH Guidelines?
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- ICH is 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 ICH aims to enhance the harmonization worldwide to make sure that safe, high quality and effective drugs are developed and registered most efficiently.
- ICH provides guidelines on 4 aspects that is quality, safety, Efficacy, and Multidisciplinary guidelines.
Q16) What is SOP?
- The SOP is known as Standard Operating Procedure.
Q17)Explained IQ OQ PQ DQ
- IQ- Installation Qualification
- OQ-Operational Qualification
- PQ-Performance Qualification
- DQ-Design Qualification
Q18) Difference between validation and calibration
- Verification produces documentary evidence assuring a specific process/process or activity which continually develops a product with predefined specifications and quality credits. This is done according to the verification protocol.
- Calibration shows that the equipment produces values in specified boundaries by comparing the values produced by a standard. This calibration is done according to the standard operating procedure.
Q19) Expand BMR and BPR?
- BMR Batch Manufacturing Record is prepared as a written file during the manufacturing a product by writing. Step by the step manufacturing process and details about batch recorded here.
- BPR Batch Packaging Record is kept for every BMR. BPR depends on packaging operation.
Q20) What do you know about stability studies?
Ans)
- These are necessary for developing 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.
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Q21) What is the period required for the long term and accelerated stability studies?
Ans)
- Long term 12 months, Accelerated studies- 6 months
Q22) What are the 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)
Pharma interview questions for formulation production jobs
Q23-. Define the tablet?
Ans)
- Tablet is a solid dosage form. It contains the Active pharmaceutical ingredient(API) along with the excipients.
Q24-. Define API?
Ans)
- API, known as Active pharmaceutical Ingredient. First and an important ingredient in any drug formulation. It is a biologically active component responsible for the drug effect.
Q25-. 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.
Q26-. Give the examples for diluents and lubricants?
Ans)
- Diluents- Mannitol, sorbitol, starch, lactose, sucrose etc.
- Lubricants Magnesium stearate, calcium stearate, stearic acid, etc.
Q27-. Name the tablet preparation methods?
Ans)
Wet granulation, Dry granulation, Direct compression.
Q28- Explain the wet granulation, dry granulation, and direct compression?
- 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, the blend of API and Excipients are directly compressed to form tablets without changing the physical nature of the material itself.
Q29- Name any three tablet processing problems and explain it?
Ans)
- Mottling, Capping, and lamination.
- Mottling- unequal color distribution of a tablet.
- Capping- Partial or complete separation of a tabletop or bottom crowns.
- Lamination- Separation of tablets into two or more layers.
Q30- 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 localized portion to the punch faces resulting in a rough and dull appearance.
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.
Q32-.Explain about hard gelatin capsules?
Ans)
- It contains two parts called the body and cap. Body, a long narrow section. Cap, a smaller wide portion, it fixes over the body.
Q33-) What is the biggest and smallest capsule size?
Ans)
- Biggest capsule size -000, Smallest capsule size 5.
Q34-) Define parenteral?
Ans)
- Sterile dosage forms administered by injections thorough one more layers of the skin.
Q35-) Explain about Water For Injection(WFI)?
Ans)
- Purified water without any pyrogen, prepared by distillation or reverse osmosis.
Q36-) What is pyrogen?
Ans)
- Metabolic products of microorganisms. Produced from living or dead microorganisms.
Q37-) Difference between water for injection(WFI) and sterile water for injection(SWFI)?
- WFI Purified water without any pyrogen
- SWFI Purified and sterile water without any pyrogen
Q38-) Difference between ampule and vial?
Ans)
- Ampule- simple dose unit. Vial- Multiple dose unit.
Q39-) Use of additives in the parenteral formulations?
Ans)
- Additives used for increasing the stability of solutions.
Q40-) Explain different types of additives with examples?
Ans)
- Antioxidants 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 antioxidants.
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, phenylmercuric acetate, Thiomersal.
Q41-) Give examples of tonicity modifiers?
Ans)
- Sodium chloride, Dextrose.
Q42-) Which colors used in parenteral formulations?
Ans)
- Colors will not be used in the parenteral formulations.
Answer all the questions (Each correct answer carries 2 marks)
Q43-Write the chemical names?
a. Vitamin B6
b. Vitamin B12
Q44-Write any two lubricants, which are used in tablets manufacturing?
Q45-Write the abbreviations of IP and BP?
Q46-What is friability test and how to calculate it?
Q47-What are the steps involved in a wet granulation process?
Q48-Define API and explain it?
Q49-Write any two types of formulations and explain it?
Q50-Name any two sources of Vitamin C? Write any disease caused by vitamin c deficiency?
Q51-What is oxymel?
Expand the UHPLC, TLC, LVP, and SVP?
Answers:
1)
a) Vitamin B6- Pyridoxine
b) Vitamin B12 Cyanocobalamin
2) Commonly used lubricants are Talc, silica, Stearic acid, and Magnesium stearate, etc
3) IP full form Indian Pharmacopoeia
BP full form British Pharmacopoeia
4) Friability test is conducted to know the physical strength of a tablet. It is the withstanding capacity of a tablet when it is on manufacturing and transportation.
It is calculated by using this formula
Friability =(Initial weight- Final weight)/Initial weight * 100
Initial weight in mg- before the test
Final weight in mg- after completion of the test
5) Following steps involved in the wet granulation process
- Mixing
- Drying
- Dry screening
- Fluid bed granulation
6) API is known as Active Pharmaceutical Ingredient. A first and most important component of any formulation. There is no finished dose formulation is available without having an API.
7) Various types of formulations are available
Topical formulations:
This type of formulations is administered by local route, applied on the skin. The active ingredient in formulation does not enter into the systemic circulation.
e.g Topical creams
Parenteral formulations:
These formulations are administered by the parenteral route into the blood. The ingredients in the formulation have directly entered the blood. Bioavailability is high for this formulations.
ex: Intravenous Injections
8) Oranges, Lemons, and Tomatoes are sources for vitamin C. Severe deficiency of vitamin C causes scurvy disease.
9) Oxymel is a mixture of honey, water, and vinegar.
10) UHPLC is known as Ultra-High-Performance Liquid Chromatography.
LVP is known as Large Volume Parenteral
SVP is known as Small Volume Parenteral
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