Interview questions for quality control analyst in pharma industry

Interview questions for quality control analyst in Pharma Industry

We have provided interview questions for quality control analyst here. You have to know all these question answers before attending an interview. We have already provided interview questions for quality control analyst in our previous post. This post includes some more important questions for interview. These are useful for freshers as well experienced people. Have a knowledge on all these questions before attending the interview.

interview questions for quality control analyst are as follows.

Acceptance Limit for Friability of tablets?

Ans) Acceptable tablets weight loss is 0.5 to 1.0% for 100 revolutions. Or 1-5% weight loss for 10 minutes revolution. ( Generally 6 grams of weighed and de dusted tablets place in the rotating apparatus, it revolves at a speed of 25 revolutions per minute i.e 25 rpm. Tablets freely falls from 6 inch height for every rotation. These tablets subjected to 100 rotations or for 10 minutes i.e 250 rotations (10 min*25rpm)).

Acceptance limit for uniformity of content of tablets?

Ans) There are two criterias for acceptance limit.

Take 30 randomly selected tablets. Take 10 tablets, and assay individually. 9 out of 10 tablets should be in the range of 85% to 115%. One tablet can be in the range of 75%-125%. If this criteria fits, it passes the test. If these conditions not met, remaining 20 tablets should be assayed. All of the 20 tablets should in the range of 85% to 115%.

What are different types of capsule sizes and holding capacity of smallest and largest size?

Ans) Sizes are 000, 00 , 0, 1, 2, 3, 4, 5.

Smallest size 5, It can hold at least 65 mg of drug.

Largest size 000, It can hold up to 1000 mg of drug.

What are the types of Gas Chromatography?

Ans) Two types available.

Gas Solid chromatography(GSC) : Stationary phase is solid and gas used as mobile phase.

Gas Liquid chromatography(GLC): Liquid on a thin solid support used as stationary phase and gas used as mobile phase.

Which material used as stationary phase and mobile phase in GSC and GLC ?

Ans) Granular silica, alumina or carbon used as stationary in phase in GSC. Non volatile liquid on solid base like Diatomaceous earth or kieselghar used as stationary phase in GLC. Inert gases like helium or nitrogen used as mobile phase(carrier gas) in both GSC and GLC.

which type of tablets does not require Disintegration test?

Ans) Sustained release tablets, Delayed released tablets and Chewable tablets.

interview questions for quality control analyst

What is disintegration time for Uncoated , coated, enteric coated, dispersible and soluble tablets?

Ans) Uncoated tablets – 30 min (Uses water as medium at 37+20C temperature)

Coated tablets- 30 min (Uses water as medium at 37+20C temperature)

Enteric Coated tablets- 60 min (Uses mixed phosphate buffer at 37+20C temperature) or It should no disintegration for 2 hours (Using in 0.1N Hcl as medium at 37+20C temperature)

Dispersible tablets – 3 min (Uses water as medium at 19 to 210C temperature)

Dispersible tablets – 3 min (Uses water as medium at 19 to 210C temperature)

What is disintegration time for soft gelatin and Hard gelatin capsules?

Ans)

Soft gelatin capsules- 60 min (Uses water as medium at 210C temperature)

Hard gelatin capsules – 30 min (Uses water as medium at 210C temperature)

Accuracy VS Precision:

Accuracy also known as trueness. Analytical Procedure accuracy is the closeness between the accepted reference value or conventional true value and the result value. One measurement is enough to determine the accuracy of an analytical procedure. It does not tell about the quality.

For accepted reference value is 20, you result value is 19.9 or 20.1. Then it is said as high accuracy.

In the same case, your result value is 18.7 0r 21.4. Then it is stated as low accuracy.

Precision: Analytical Procedure precision is the closeness between a number of measurements taken  from the homogenous sample multiple samplings under specified conditions. To measure the precision of an analytical procedure requires several measurements. It speaks about the quality.

For ex: From a homogenous sample, you have measured multiple samples, the values you obtain is

A. 19.2, 19.4, 19.3, 19.2, 19.1

B. 10.2, 10.4, 10.3, 10.2, 10.1

C. 19.2, 22.4, 16.6, 17.1, 16.9

In the above options, Result “A”& “B” said as High precision, Result “C” said as Low precision. Here the consideration is series of measurement values for a particular homogenous sample. There is no reference value in the concept of precision.

Differentiate between relative humidity and absolute humidity?

Ans) Absolute humidity also called as Humidity. Simply defined as amount of water vapour (moisture) present in a volume of air. Unit expressed as gram/m3.

“Relative” humidity: “Relative” nothing but comparison or ratio. So it is expressed in percentage(%). It is the ratio of air current water vapour/moisture/humidity to highest possible water vapour /moisture/ humidity. This highest possible humidity depends upon the current specific air temperature.

Ex: Current air contains 1 gram/m3 of water vapour (humidity), For that air it can hold up to 4 gram/m3 of water vapour (humidity) (It depends on temperature).

Relative humidity = ¼*100 = 25%

LOD:

Limit of Detection: Also known as Detection Limit. For a particular analytical procedure, Upto how much lowest amount of component or analyte  in a sample can be detected. That is the detection limit for that individual or particular analytical procedure. It does not mean that it should able to quantitate that analyte.  It should able to detect that analyte, that’s it.

LOQ: Limit of Quantitation: Also known as Quantitation Limit. For a particular analytical procedure, up to how much lowest of analyte in sample can be quantitated with suitable accuracy and precision. LOQ come into picture in quantitative assays to determine the degraded products or impurities in the samples.

Related: QA interview questions and answers 

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Clinical sas interview questions for freshers –Part 1

Clinical sas interview questions

Here we have provided a list of basic clinical SAS interview questions. These are the common questions usually asked in interview (especially for freshers). These question and answers are prepared from freshers point of view. Before attending an interview you must have at least below clinical sas interview questions and answers

Every sponsor company may not have this job vacancy(Usually MNC company have this department). Usually sponsor will outsource their work to CRO. Every Contract Research Organisation(CRO) have data management department. It includes Clinical SAS department. And this vacancy(Clinical SAS programmer) is available in this department.

Any life science graduate can learn Clinical SAS program to get a job. Clinical sas Interview questions are provided and given with a brief explanation. Due to length of this questions, clinical sas interview questions and answers divided in 3 parts. Questions and answers as follows.

1) What Is SAS?

Ans: SAS stands for the statistical analysis system or software. It is a tool for collecting, summarizing, analysing the data.it is used in the variety of domains like clinical, Banking, network marketing, Trading etc.

2) what is the use of _N_ and _Error_ in SAS?

Ans: _N_  and _Error_ is the automatic variables in SAS which created in the backend each one having its unique usages. _N_ is the number of iteration means how many times the data step or proc steps begins to execute.

And _Error_ shows the error present in the programme or not. It takes only two values 0 and 1.

If _Error_=1 then there is error present in the programme and if _Error_ =0 then there is no error present in the programme.

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3) what is the use of Proc means and by default which statistics we will get?

Ans: Proc means is the procedure in SAS which is used for finding the descriptive statistics.

By default, we will get N, minimum, maximum, mean, standard deviation.

 Syntax is as follows,

Proc means data = dataset name;

                Var variable_names;

Run;

Related: Medical representative interview questions

4) what is the use of SDTM and ADaM CDISC standard in the data management?

Ans: CDISC (clinical data interchange standard consortium) it the non-profitable organisation which defines the standards for industry drug submission Like SDTM (Study data tabulation model), AdaM (analysis dataset model, CDASH (clinical data acquisition standard harmonisation), SEND (standard for exchange of non-clinical data), LAB (laboratory dataset model), PRM (protocol representation model), ODM (operational dataset model) each standard having its unique specification. Standard implementation guides for each and every standard are created by CDISC team for easy drug regulatory submission.

SDTM is stands for study or standard data tabulation model which is use for the conversion of the Non-standard data into the standard form in the clinical domain. Because standard data is easy to analysis and it is easy for researcher to make valid interpretation from the standard data. The latest version of implementation guide for SDTM is SDTMIG v3.1.2.

ADaM is stands for the analysis dataset model. this standard is use for converting the SDTM standard dataset in to analysis ready dataset for the analysis purpose. The latest version of implementation guide for ADaM is AdaMIG v2.1.

5) How to combine the two or more datasets in SAS?

Ans: there are some methods available in SAS for combining the SAS datasets. Which is as follows

  • Concatenation: this method is used used to connect two or more dataset

The syntax is

Data Newdataset1_name;

                                Set existingdataset1_name existingdataset2_name;

Run;

  • Interleaving: this method combines the sorted datasets according the sorted by variables.

The syntax is

Proc sort data=existingdataset1 out=existingdataset1_name;

                                By Variables_name;

Run;

Proc sort data=existingdataset2 out=existingdataset2_name;

                                By variables_name;

Run;

Data Newdataset_name;

                                Set existingdataset1_name existingdataset2_name;

                         By variables_name;

run;

  • Merging: this method combines the observations from two or more datasets into single observation in the new data set.

The syntax is

Proc sort data=existingdataset1 out=existingdataset1_name;

                                By Variables_name;

Run;

Proc sort data=existingdataset2  out=existingdataset2_name;

                                By variables_name;

Run;

Data Newdataset_name;

                                merge existingdataset1_name existingdataset2_name;

                         By variables_name;

run;

6) what is the SAS datasets variables attributes?

Ans: there are 5 SAS datasets variables attributes. (Type, length, name, label, format and informat).

  1. Type: character and numeric data is the type of the variable.
  2. length: The length of variable means the how many character or digits that variables take to store the value.
  3. Name: the name of the variables
  4. format: The way in which we want to store the variable.

Ex: ddmmyy10. is the date format

  1. Informat: the variable which already in some standard SAS format and we want to convert it

into some other format it is informant.

Ex: suppose, if we want to convert 10,300 as $10,300 in SAS

Then here we will use the dollar8. Informant

7) what is the use of libname statement in SAS?

Ans: libname statement is use for the assigns the path of file which are store in some folder.by using that path we can access that files.

Syntax: libname file_ref “ path of the folder”;

8) what is the difference between proc means and proc summary?

Ans: The use of the both procedure is to make the descriptive statistics of the data and the proc summary with the print option is an identical to the proc means.

Syntax:

Proc means data = dataset_name;

                Var variable names;

Run;

Proc summary data =dataset_name print;

                Var variable_name;

Run;

9) How many different ways to create the macros in SAS?

Ans: we will create the macro for reducing the programme which reduce the time for executing it.

There are 8 different ways for creating macros in SAS which are as follows,

  1. %let statement
  2. %macro statement
  3. %global statement
  4. %local statement
  5. %windows statement
  6. %input statement
  7. into clause in proc sql
  8. using call symput routine

10) what is the use of proc report in clinical research process?

Ans: Proc report is the procedure in SAS for creating the tables that show some information regarding the study results.

Suppose in clinical trials many times we want to create shift table which show the how much shift occur form baseline to post treatment. For summarizing that results we want to create the mock up table. In SAS using Proc report procedure we will create this mock up tables.

Syntax:

Proc report data= Dataset_name;

                Column variable_names;

                Define variable_name / attributes options;

Run;

Author: Mayur Kharche (Cinical SAS programmer & Biostatistician)

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