Interview Question and Answers for Quality Control in Pharma industry
Interview Question and Answers for Quality Control in Pharmaceutical Industry
Are you looking for the job in pharmaceutical industry in
quality control department? If yes then here is some frequently asked question
and answers that may help you in your interview preparations.
The quality control department of any pharmaceutical
industry consists mainly of following subdivisions to check the quality of the
product at each step of manufacturing.
1. Raw material
2. Packing material
3. Process Validation
4. Finished Product
5. Stability Studies
6. Microbiology Studies
Raw material is the base of any product manufacturing. A
good quality raw material will definitely can produce a good quality product.
Hence it is necessary to check the quality of Active pharmaceutical ingredients
and excipients used for production. This post includes some basics that one
should know before appearing for the interview of raw material section.
If you go through pharmacopeial monograph of any
excipient or API, you can observe that there are certain tests which should
meet the specification criteria then only your raw material can be released for
production. So one should have basic knowledge of the general tests used during
the quality checking of raw materials.
Q. 1
What is quality control?
Ans. Quality control is the process by which entities
review the quality of all the factors involved in production.
Q. 2
Explain the difference between QA and QC?
Ans. QA
provides the confidence that a product will full fill the quality requirements.
QC determines and measures the product quality level.
Q. 3
What are various identification test that can be commonly used for quality
checking?
Ans. Colour development tests, Melting point, Boiling
point
IR tests : The IR spectra of raw material should match
with the standard spectra with purity index more than 0.995,
UV spectra : Standard and raw material should exhibit the
similar UV spectra, maxima and minima should be within acceptance criteria
HPLC chromatogram : Retention time of both Standard and
raw material should match.
Q.4 What
is difference between qualitative and quantitative analysis?
Ans. Qualitative analysis used for the data that cannot
be quantified e.g. Colour development test, Identification test, heavy metals,
Limit test etc.
Quantitative analysis is associated with numerical
analysis where data is collected, classified and computed for certain findings
using a set of statistical calculation methods.
Q.5 What
is solubility and its USP criteria?
Ans. Solubility is
part of solvent required to dissolve per part of solute
|
Very soluble |
Less than 1 |
|
Freely soluble |
From 1 to 10 |
|
Soluble |
From 10 to 30 |
|
Sparingly soluble |
From 30 to 100 |
|
Slightly soluble |
From 100 to 1000 |
|
Very Slightly soluble |
From 1000 to 10000 |
|
Practically insoluble |
10000 and above |
Ans. These are metallic impurities detected by inorganic
qualitative analysis like colour development and precipitation reaction. For
example, Lead, Mercury, Bismuth, Arsenic, Copper, Silver etc.
Q. 7 What do you mean by LOD and water content?
Ans. LOD is loss on drying. It is used to estimate the
water and other volatile solvents present in the substance. It is mainly used
for material which is purified by solvents. It is dry base.
Water content gives moisture or water present in sample
only. It removes combined form of water. It is anhydrous base.
Q. 8 What
is the difference between Drug Purity and Drug Potency?
Purity is the amount of API present in sample compared to
those of related substances, impurities, residual solvents.
It is calculated by area
normalisation method, it can be directly find out by
chromatograms obtained from HPLC.
% Purity = (Area of desired peak / Sum of area of all peaks) x 100
100 – (moisture or LOD + residual solvents + heavy
metals + sulphated ash + impurities)
Q. 9
What is Residue on ignition and sulphated ash test?
Ans. It utilizes a procedure to measure the amount of
residual substances not volatilized from sample when ignited in the presence of
sulphuric acid as per described procedure. It is used to determine content of
inorganic impurities in organic substances.
Q.10
What is bulk density, tapped density?
Ans. The bulk density of a material is the
ratio of the mass to the volume (including the interparticulate void volume) of
an untapped powder sample.
The tapped density is obtained by
mechanically tapping a graduated cylinder containing the sample until little further
volume change is observed.
The bulk density is given in g/ml. The bulk density depends on both the
density of the powder particles and on the arrangement of the powder particles.
The bulk density is influenced by the preparation, treatment and storage of the
sample material.
Q. 11 What
is sieve analysis?
Ans. Sieve analysis is a technique used to
determine the particle size distribution of a powder. This method is performed
by sifting a powder sample through a stack of wire mesh sieves, separating it
into discrete size ranges. A sieve shaker is used to vibrate the sieve stack
for a specific period of time. Vibration allows irregularly shaped particles to
reorient as they fall through the sieves. Additionally, agitation of the sieves
serves to break apart weak
agglomerates, allowing for a more reliable measurement of
the particle size distribution. The particle size distribution of a powder
serves as an indication of flowability. Powders with a
broad size distribution
tend to be poorer flowing than those with a narrow size distribution.
Q. 12 Why
we use disodium tartarate for determination of factor in Karl Fischer ?
Ans. It is stable and non hygroscopic. It releases free
water molecule easily when reacts with KF reagent. It is easily soluble in
methanol and has stoichiometic water content of 15.66%.
Q. 13 How to
calculate assay?
Ans. It is calculated against
standard. It may be of following types:
1) On as is basis = (Area of sample / Area of standard) x (conc. of standard / conc. of sample) x potency or assay of standard
2) On anhydrous basis = (Assay
on as is basis / 100 – moisture) x 100
3) On dried basis = (Assay on
as is basis / 100 – LOD) x 100
Ans. There are various methods
of RS calculation. Click the below mentioned link to know it.
https://pharmersfields05.blogspot.com/2021/01/methods-of-impurities-calculation.html
Ans. Limit tests are semiquantitative
or quantitative methods designed to identify and control small quantities of
impurities which are likely to be present in the substances. e.g. Chlorides,
Sulphates, iron and heavy metals like
lead, Arsenic etc. One should know the principle of all the reactions used in
limit test.
Q.16 What are different types of impurities?
Ans. There are
mainly three types of impurities
Organic Impurities : These
are often process-related or drug-related pharmaceutical impurities. These
types of contaminants are most likely to arise during the synthesis,
purification, and storage of the drug substance. A few examples include starting
materials, by-products, intermediates, degradation products, reagents, ligands,
and catalysts.
Inorganic Impurities : These
impurities often derive from the manufacturing process. These impurities are
often reagents, ligands, catalysts, heavy or residual metals, inorganic salts,
filter aids, or charcoals. Inorganic contaminants can be detected and
quantified using pharmacopeial standards.
Residual Solvents : These
impurities are residuals of solvents present in the manufacturing process.
Solvents used in pharmaceutical manufacturing are defined by three classes
based on their toxicity. Class one solvents should always be avoided, as they
are known to be human carcinogens or environmentally hazardous. Class two
solvents should have limited use, as some levels of harmful toxicity may be
present. Class three solvents have low toxic potential to humans and do not
need a limit.
Apart from above, one should have knowledge about
principles of all analytical techniques used in analysis of raw materials e.g.
HPLC, UV Visible spectrophotometer, KF Autotitrator, IR, Particle size analyzer,
potentiometer, pH meter etc.
Hope this post will be useful for your
interview preparation. We will try to post next article related to
pharmaceutical industries as early as possible. Please share your valuable
comments after reading.
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