QC Pharma Interview Questions For Freshers

QC pharma interview questions:

QC pharma jobs offered for b pharmacy freshers in pharmaceutical industry. Usually, first you should qualify an interview exam for attending the interview. It is depend upon the which pharmaceutical company you are trying for.

Here we have given most commonly asked basic questions in the qc pharma interview for freshers. There is no specific pattern/rule for asking the interview questions. Its purely an interviewer choice. But still we try to give qc pharma interview information which they are asking mostly based on some experienced interviewees suggestions.

We are not discussing any HR related questions except qc pharma technical questions.

Related: B pharmacy interview exam questions for freshers

Quality control interview Questions:

Q1. What is room temperature?

Ans) 25 degree centigrade

Q2.  What is the Ultraviolet(UV) and visible spectroscopy range?

Ans) UV spectroscopy range 200-400 nm, Visible spectroscopy range 400 nm to 800nm.

Q3) What is the use of UV Spectroscopy?

Ans) Spectroscopy used for detecting the functional groups, impurities. Qualitative and quantitative analysis can be done.

Q4) What is the difference between qualitative and quantitative analysis?

Ans) Qualitative analysis involves identification of the compound or chemical based on their chemical(absorption, emission )or physical properties(e.g Melting point, boiling point).

Quantitative analysis involves estimation or determination of concentration or amount of the chemical compounds or components.

Q5) Explain the principle of Ultraviolet spectroscopy?

Ans) UV spectroscopy uses light in the UV part of electromagnetic spectrum. UV absorption spectra arises in which molecule or atoms outer electrons absorb energy, undergoes transition from lower energy level to higher energy level. For each molecule, absorbance at wavelength is specific.

Q6) Explain about Beer Lamberts law?

Ans) It states that the intensity of monochromatic light absorbed by a substance dissolved in a fully transmitting solvent is directly proportional to the substance concentration and the path length of the light through the solution.

Q7)  Explain the Infrared spectroscopy principle?

Ans) When a molecule absorbs the Infrared radiation, it vibrates and gives rise to packed Infrared(IR) absorption spectrum. This IR spectrum is specific for every different molecule absorbing the IR radiation, useful for its  identification.

Q8) What is the body temperature?

Ans) 37 oCelsius or 98.6 oF

Q9) Define pH? What is the pH of blood?

Ans) pH -Negative logarithm of hydrogen ion concentration. Blood pH-7.35 to 7.45.

Q10) Expand LCMS, HPLC,UPLC, TLC and GC?

Ans) LCMS- Liquid Chromatography

HPLC- High Performance Liquid Chromatography,

UPLC- Ultra High Performance Liquid Chomatography,

TLC- Thin Layer Chomatography,

GC- Gas Chromatography.

qc pharma interview questions for freshers

Q11) What is the HPLC principle?

Ans) It is a technique used for separating the mixture of components into individual components based on adsorption, partition, ion exchange and size exclusion principles. Stationary phase and mobile phase used in it.  HPLC used for identification, quantification and purification of components form a mixture.

Q12) Explain HPLC instrumentation?

Ans) It involves solvent system, pump, Sample injector, HPLC columns, Detectors and Recorder. Firstly, solvent(mobile phase) is degassed for eliminating the bubbles. It is passed through the pump with a uniform pressure. The liquid sample is injected into the mobile phase flow stream. It passes through the stationary phase identified by the detectors and recorded.

Q13) In reverse phase HPLC, which type of stationary phase is used and give example?

Ans) Non polar stationary phase used

Ex: Silica gel C-18

Q14) What are the detectors used in HPLC?

Ans) UV detector, IR detector, Fluorescence detector, Mass spectroscopy, LC MS etc.

Q15) How to calculate Retention factor in paper chromatography?

Ans) Rf = Distance travelled by solute/ Distance travelled by solvent.

Q16) Define molarity?

Ans) Number of moles of solute per litre solution. Denoted with “M”

Q17) Define Molality?

Ans) Number of moles of solute per kilogram solvent. Denoted with “m”

Q18) Define Normality?

Ans) Number of Number of moles equivalent per litre solution.

Q19) Molecular weight of oxygen?

Ans) 16

Q20)  Difference between humidity and relative humidity?

Ans) Humidity – Measure of amount of water vapour present in the atmosphere.

Relative humidity- Water vapour amount exists in air expressed as a percentage of the amount needed for saturation at the same temperature.

I have prepared a few more important questions and answers for you. You can also visit additional qc interview questions here.

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Interview questions for quality assurance in pharmaceutical industry

Interview questions for quality assurance in pharmaceutical industry:

We have provided interview questions for quality assurance in pharmaceutical industry here. There is no specified differences between quality control and quality assurance from interview point of view. They are all interlinked. But we tried to prepare in separate posts and produced. This post is an extension to our previous interview questions for quality assurance in pharmaceutical industry. If you attending an interview, you have to all these questions and answers in these 4 posts. It helps you a lot to face interview well.

Interview questions for quality assurance in pharmaceutical industry are as follows.

Qa-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 approved, validated and able to traceable. Change control deals and makes sure all these changes.

Explain about Bracketing and Matrixing study designs in stability testing/

Ans) 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 are 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 to test all the samples at all time points. These study designs mostly used when multiple design factors involved.

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 intermediate levels stability 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 the 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’s an important part of 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.

Explain about Out of Specification (OOS) results and Out Of Expectation (OOE) results?

Out Of Specification (OOS) results: Analysed test result falling out side 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 falls out side the procedure expected variability.

Interview questions for quality assurance in pharmaceutical industry 

Interview questions for quality assurance in pharmaceutical industry:

Stress Testing:

Also called as Forced degradation study, stress study. Forced degradation study intended to know the degradation products, it will helps 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 regulatory authority requirement.

What is the purpose/use(s) of stability testing?

Ans) Stability testing gives the confirmation as 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 stability of a drug product. Stability testing is a regulatory requirement also.

What are different types of stability studies along with its conditions?

Ans)

Long-term stability studies: Storage conditions 25+20C, 60+5% RH and Minimum Time period is 12 months

Intermediate stability studies: Storage conditions 30+20C, 60+5% RH and Minimum Time period is 6 months

Accelerated stability studies: Storage conditions40+20C, 75+5% RH and Minimum Time period is 6 months

Dead leg: Dead logs not allowed in water design systems. These are the stagnant areas with no water flow. It allows microbial contamination resulting the surface colonisation by forming biofilms. If a dead log present in any case, it should have particular pipe diameter and velocity. In general agreement in industry, dead log should not be more than the pipe diameter.

For e.g: If the pipe diameter is 5 cm , then dead log should not be more than 10cm.

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.

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.

Process validation:

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 prior to process implementation to assuring that process is performs as intended on the basis of pre-planned plans.

Concurrent validation: Conducted during the product routine production.

Retrospective validation: Conducted on some products , those products which are already on commercial market. The intention is to establish the long term compliance of that product.

Re-validation: This is nothing but repetition of validation. Conducted to assuring that the changes/modifications done in equipment/process in according to the change control procedures. Those changes are not effecting the equipment/process and their produced products adversely.

This is the second post regarding Interview questions for quality assurance in pharmaceutical industry. You can view the previous post  QA interview questions and answers.

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