1.

What is Quality Control :

The term quality control refers to the sum of all procedures undertaken to

ensure the identity and purity of a particular pharmaceutical product. It
involves in chemical, physical and some time microbiological testing of
a pharmaceutical product.

Quality control involves testing of pharmaceutical products against the

specifications.

The other responsibilities of Quality Control are sampling of Raw & packing
material, Testing of raw material, packing material, In process, Finished
product& Stability batches, Sampling & testing of water, Calibration of
Instruments, Preparation of Specification of Raw, Packing, In process &
Finished products, Preparation of Standard Test procedure of Raw, Packing,
In process & Finished products and reporting of result after analysis &
preparation of COA.

2. What is Disintegration Test :

It is the time required for the Tablet / Capsule to break into particles, the
disintegration test is a measure of the time required under a given set of
conditions (Temperature) for a group of tablets/capsules to disintegrate into
particles.

Cycle of shaft holding the tube basket limit is 29-32 cycles per minutes and
distance covered by shaft basket is 50-60 mm and beaker temperature is 35 to
39 º C.

Disintegration is to be Performed to determine whether tablets or capsules

disintegrate within the prescribed time when placed in a liquid medium at the
experimental conditions.

3. What are the Disintegration Time of tablets :

 Uncoated Tablet 15 min as per BP

 Uncoated Tablet 30 min as per USP
 Sugar Coated Tablet 60 min as per BP
 Film Coated Tablet 30 min as per BP
 Plain Coated Tablets DT in specific medium for 30 min as per USP
 Enteric Coated Tablets DT in  simulated gastric fluid (0.1 M HCl) for 1
hr and then in simulated intestinal fluid (Phosphate buffer 6.8 pH)
until disintegrate as per USP.
  Dispersible Tablets 3 min ( 15- 25º C ) as per BP.
 Effervescent Tablets 1 tablet in 200 mL water  for 5 min ( 15- 25º C )
 as per BP
 Buccal Tablets 4 hrs as per USP.
 Soluble Tablets 3 min ( 15- 25º C ) as per BP.
 Chewable Tablets are not require to comply with test
4. What are the Disintegration Time of capsules:

 Gastro resistant capsule DT 2 hrs without disk in 0.1 M HCl  and

phosphate buffer pH 6.8 for further  60 min as per BP.
 Hard and Soft gelatin capsule DT 30 min as per BP & USP.
5. What is Friability Test of Tablet & friability calculation :

Friability is defined as the percentage of weight loss of powder from the

surface of the tablets due to mechanical action and the test is performed to
measure the weight loss during transportation.

Friability (%)  =W1– W2/W1X100

Where,
W1 = Weight of Tablets (Initial / Before Tumbling) &
W2 = Weight of Tablets (After Tumbling or friability)

Limit : Friability (%) = Not More Than 1.0 %

Tablets with individual weight equal to or less than 650 mg then take the
sample of whole corresponding to as near as 6.5 gram equivalent and tablets
with individual weight more than 650 mg then take sample of 10 whole tablets
to perform friability test. Tablets must be de-dusted prior to and after use.

6. What is Incident :

Any unplanned or uncontrolled event in the form of non-compliance to the

designed systems or procedures at any stage of testing, and storage of drug
product due to system failure or equipment breakdown or manual error.

A laboratory Incident is an event in the laboratory that occurs for two primary
reasons either due to analyst error or instrument error.

7. What is Calibration:
The demonstration that a particular instrument or device produces results
within specified limits  by comparison with those produced by a traceable
standard over an appropriate range of  measurements.

8. What is Qualification :

The action of proving that any equipment or process work correctly and
consistently and  produces the expected result. Qualification is part of, but not
limited to a validation process, i.e. Installation Qualification (IQ), Operation
Qualification(OQ) and Performance Qualification (PQ).

The act of planning, carrying out and recording the results of tests on
equipment to confirm its capabilities and to demonstrate that it will perform
consistently as intended use and against predefined specification.

9. What is Deviation:

Any unwanted event that represents a departure from approved processes or

procedures or instruction or specification or established standard or from
what is required. Deviations can occur during manufacturing, packing,
sampling and testing of drug products.

Examples of Deviations: Temperature and RH of area goes out of limit

during manufacturing, Typographical error observed in approved documents,
Standard operating procedure not followed, Breakdown of equipment,
Spillage of material during unloading, Instrument calibration results goes out
of limit etc. Deviations are of three types Minor, Major and Critical

10. What is Change Control :

It is a Approved Procedure which is taken to change in any documents,

Standard operating procedures, Specification, Process parameters and change
in batch size etc. Change control is raised by user department as per
requirement and finally the change control is approved by Quality assurance.
Change control can be raised through software or through manually.

After Final approval of change control the changes can be made in documents
and change control can be closed after completion of required action plan
which is mentioned in the Change control form.

Change controls are of two types i.e Major and Minor.

11. Corrective action & Preventive action :

Corrective action :

An action taken to eliminate the cause of the existing deviation, incident or

problem in order to prevent its recurrence (occurring again).

Preventive action:

An action taken to eliminate the cause of potential deviation, incident or

problem in order to prevent its occurrence (an incident or event).

12. What is Chromatography :

Chromatography is an analytical technique commonly used for separating a

mixture of chemical substances into its individual components, so that the
individual components can be thoroughly analyzed.

Chromatography is a laboratory technique for the separation of a mixture. The

mixture is dissolved in a fluid called the mobile phase, which carries it through
a structure holding another material called the stationary phase and the
separation is based on differential partitioning between the mobile and
stationary phases.

13. What is difference between Stationary Phase Mobile Phase:

The key difference between stationary and mobile phase is that stationary

phase does not move with the sample whereas mobile phase moves with the
sample. Stationary phase and mobile phase are two important terms in
chromatography, which is a technique of separation and identification of the
components in a mixture.

14. What is Column in Chromatography:

A Chromatography column is a device used in chromatography for the

separation of chemical compounds. A chromatography column contains
the stationary phase, allowing the mobile phase to pass through it. The
columns are mostly made of borosilicate glass, acrylic glass or stainless steel.

15. Which gas is used in Gas Chromatography :

In GC Nitrogen, Helium and Hydrogen  are considered to be suitable carrier

gases but Helium is most widely used due to safety concerns  associated with
hydrogen and also the fact that nitrogen  is much less efficient.

16. What is HPLC in Chemistry :

High-performance liquid chromatography (HPLC) is a technique in
analytical chemistry which is used to separate, identify, and evaluate each
component in a mixture.

17. What is System suitability:

Before start of analysis of the Chromatographic system like HPLC &GC system
suitability has to perform to know that the system is working properly or to
know the performance.

System suitability criteria may include such factors as plate count, tailing,

retention, and/or resolution and the above factors are most important as they
indicate system specificity, precision, and column stability.

18. What is RT & RRT in HPLC :

The amount of time it takes for the compound to pass through the column is
the retention time (RT). The relative retention time (RRT) is the comparison
of the RT of one compound to another.

19. Types of HPLC Pumps :

There are 3 main types of HPLC Pumps : Reciprocating pump, Displacement

(or syringe) pump and Pneumatic (or constant pressure) pump.

20. What is Trailing factors :

The tailing factor is a measure of peak tailing. It is defined as the distance

from the front slope of the peak to the back slope divided by twice the distance
from the center line of the peak to the front slope, with all measurements
made at 5% of the maximum peak height.

21. What are the different Types of  HPLC Columns :

The different Types of HPLC Columns are Normal phase, Reverse Phase, Ion
Exchange and  Size Exclusion columns.

22. What is Good Laboratory Practice (GLP) :

Good Laboratory Practice contains a set of principles that provides a

framework within which laboratory studies (Activities) are planned,
performed, monitored, recorded, reported and archived. GLP help assure
regulatory authorities that the data submitted are a true reflection of the
results obtained during the study and can therefore be confidence upon when
marking risk/safety assessment.
Good Laboratory Practice contains different principles which are designed to
ensure and promote consistency, quality, safety, reliability and integrity of
chemicals during non-clinical and laboratory testing.

23. What is Working & Reference Standard :

A reference standard is the traceable, raw material standard (usually in

crystallized form) that we dissolve and volumetrically dilute to make
our working standard. The working standard is what we use to “do our work.”
and this information makes it traceable and is recorded in the preparation
notebook.

A reference standard is prepared for use as the standard in an assay,

identification, or purity test and should have a quality appropriate for its use.

24. Why is Dissolution test Required :

Dissolution tests are performed to establish drug (Active Pharmaceutical

Ingredient) release characteristics of solid oral products, such as tablets and
capsules. The rationale for conducting these tests is that for a product to be
therapeutically effective, the drug must be released from the product and
should generally be dissolved in the fluid of the gastrointestinal (GI) tract. The
API in solution form facilitates the absorption of the drug from the GI tract
into the systemic (blood) circulation to reach its desired target (site of action)
to exert its effect.

25. How dissolution test is Performed :

The drug is placed within the medium in the vessels after it has reached
sufficient temperature and then the dissolution apparatus is operated. Sample
solutions collected from dissolution testing are commonly analyzed by HPLC
or Ultraviolet–visible spectroscopy.

26. What is Q Stands for in Dissolution :

‘Q’ is the amount of dissolved active ingredient specified in the monograph

which is required to be released in the stated time, expressed as a percentage
of labelled strength, then the batch of the tablet or capsules is acceptable, if
each unit is not less than Q + 5 %.

If the initial sample analysis, known as S1 or stage 1 testing fails to meet the
acceptable value for Q, then additional testing known as stage 2 and 3 testing
is required. S3 testing is performed only if S2 testing fails in Q parameter. If
there is a deviation from the acceptable Q values at S3, then an OOS (Out of
Specification) investigation is generally initiated.

27. Which tablets are used in Calibration of dissolution Apparatus :

Non disintegrating (Salicylic Acid) and disintegrating (Prednisone) tablets are

used in the calibration of dissolution test apparatus.

28. What is Gas Chromatography :

Gas Chromatography is a common type of chromatography which is used for

separating and analyzing compounds that can be vaporized without
decomposition. Particular uses of GC include testing the purity of a particular
substance, or separating the different components of a mixture and in some
situations, GC may help in identifying a compound.

In gas chromatography, the mobile phase is a carrier gas, usually an inert gas
such as helium or an un reactive gas such as nitrogen.

29. What is Karl Fischer Titration:

Karl Fischer titration is a classic titration method in chemical analysis that use
s coulometric or  volumetric titration to determine trace amounts of water in a
sample. It was invented in 1935 by the German chemist Karl Fischer. 

30. What is KF Reaction : The Karl Fischer Titration is a titration method

for measuring water content in basically all types of substances. The Karl
Fischer Titration is based on an iodine / iodid reaction and the the water
reacts with iodine.

The endpoint of the titration is reached when all the water is consumed and
the process uses an organic base (B), sulphur dioxide, iodine and an alcohol. 

31. What is Infrared Spectroscopy :

The infrared spectrum of a sample is recorded by passing a beam of infrared

light through the sample and when the frequency of the IR is the same as the
vibrational frequency of a bond or collection of bonds, absorption occurs.
Examination of the transmitted light reveals how much energy was absorbed
at each frequency (or wavelength). This measurement can be achieved by
scanning the wavelength range using a monochromator.

32. What is the use of Incubator :

An incubator is a device used to grow and maintain microbiological
cultures or cell cultures. The incubator maintains
optimal temperature, humidity and other conditions such as the
CO2 and oxygen content of the atmosphere inside. Incubators are essential for
a lot of experimental work in cell biology, microbiology and molecular
biology and are used to culture bacterial  cells.

33. What is Out of Specification :

Out of Specification (OOS) means the test result that falls outside the
specifications or acceptance criteria which has been specified in the official
monographs or the Blend, In process, Raw material, Packing material,
Stability and finished product specification.

During analysis if any OOS observed then it should be investigated to find out
the root cause and required Corrective & preventive actions shall be taken to
avoid the reoccurrence.

There are two phases of Investigation Laboratory investigation and production

process investigation.

34. What is Out of Trend :

Out of Trend (OOT) means the test result that is within the specification limit
or acceptance criteria as mentioned in the Blend, In process, Raw material,
Packing material, Stability and finished product specification but outside the
trend of previously tested batches.

Suppose X Product has the Specification limit 95 to 105 % & we have tested
many batches of product X and the trend result shows is 98 to 102 %. Suppose
X Product current result is  97.5 % so in this case it is called OOT.

35. What is Stability Study :

Stability of a pharmaceutical product means how long it can maintain its

original form for the duration of the shelf life assigned to it and should comply
the specification without any visible changes under the influence various
environmental factors like temperature and humidity.

The pharmaceutical industry conducts this testing to develop a new product

and establish the shelf-life of a product.

36. What is Bracketing in Stability Testing :

The design in which only the extremes are tested at all  time points e.g.,
strength, pack size, container fill etc. are tested.

Bracketing is applicable if the strength are identical or very closely related in

composition (e.g. for a tablet range made with the different compression
weights of similar basic granulation, or a capsule range made by filling
different plug fill weight of the same basic composition in to different size
capsule shells. Bracketing can be applied to different container sizes or
different fills in the same container closure system).

37. What is Shelf Life :

The period of time during which a drug product, if stored correctly, is expected
to comply with the specifications determined by stability studies on a number
of batches of the product. The shelf life is used to establish the expiry date of
each batch.

38. In stability how many conditions are there :

There are Three stability Condition Long term or Controlled Room

Temperature (CRT), Accelerated and Intermediate

39. What is Significant changes in Stability Study :

At long term and intermediate condition : Failure to meet the

specification is considered as significant change.

At accelerated condition : Following changes are considered as

“Significant change”.

A 5% change in assay from its initial value, any degradation product exceeding
its acceptance criterion. Failure to meet the acceptance criteria for
appearance, physical attributes. Failure to meet the acceptance criteria for
dissolution.

40. What is limit of detection (LOD) :

The detection limit of an individual analytical procedure is the lowest amount

of analyte in a sample which can be detected but not necessarily quantitated as
an exact value. Several approaches for determining the detection limit are
possible.
Based on visual evaluation the detection limit is determined by the analysis of
samples with known concentrations of analyte and by establishing the
minimum level at which the analyte can be reliably detected.

41. What is limit of Quantification (LOQ) :

The quantification limit of an individual analytical procedure is the lowest

amount of analyte in a sample which can be quantitatively determined with
suitable precision and accuracy. The quantification limit is a parameter of
quantitative assays for low levels of compounds in sample matrices, and is
used particularly for the determination of impurities and/or degradation
products

1.Question 1. What Is Room Temperature?

Answer :
25 degree centigrade
2.Question 2. What Is The Ultraviolet(uv) And Visible Spectroscopy
Range?
Answer :
UV spectroscopy range 200-400 nm, Visible spectroscopy range 400
nm to 800nm.

3.Question 3. What Is The Use Of Uv Spectroscopy?

Answer :
Spectroscopy used for detecting the functional groups, impurities.
Qualitative and quantitative analysis can be done.
4.Question 4. What Is The Difference Between Qualitative And
Quantitative Analysis?
Answer :
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.

5.Question 5. Explain The Principle Of Ultraviolet Spectroscopy?

Answer :
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.

6.Question 6. Explain About Beer Lamberts Law?

Answer :
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.
7.Question 7. Explain The Infrared Spectroscopy Principle?
Answer :
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.

8.Question 8. What Is The Body Temperature?

Answer :
37oCelsius or 98.6oF
9.Question 9. Define Ph? What Is The Ph Of Blood?
Answer :
pH -Negative logarithm of hydrogen ion concentration. Blood pH-7.35
to 7.45.

10. Question 10. Expand Lcms, Hplc,uplc, Tlc And Gc?

Answer :
o LCMS- Liquid Chromatography
o HPLC- High Performance Liquid Chromatography,
o UPLC- Ultra High Performance Liquid Chromatography,
o TLC- Thin Layer Chomatography,
o GC- Gas Chromatography.
11. Question 11. What Is The Hplc Principle?
Answer :
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.

12. Question 12. Explain Hplc Instrumentation?

Answer :
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.

13. Question 13. In Reverse Phase Hplc, Which Type Of Stationary Phase
Is Used And Give Example?
Answer :
Non polar stationary phase used
Ex: Silica gel C-18
14. Question 14. What Are The Detectors Used In Hplc?
Answer :
UV detector, IR detector, Fluorescence detector, Mass spectroscopy, LC
MS etc.
15. Question 15. How To Calculate Retention Factor In Paper
Chromatography?
Answer :
Rf = Distance travelled by solute/ Distance travelled by solvent.

16. Question 16. Define Molarity?

Answer :
Number of moles of solute per litre solution. Denoted with “M”
17. Question 17. Define Molality?
Answer :
Number of moles of solute per kilogram solvent. Denoted with “m”

18. Question 18. Define Normality?

Answer :
Number of Number of moles equivalent per litre solution.
 19. Question 19. Molecular Weight Of Oxygen?
Answer :
16
20. Question 20. Difference Between Humidity And Relative Humidity?
Answer :
o Humidity – Measure of amount of water vapour present in the
atmosphere.
o Relative humidity- Water vapour amount exists in air
expressed as a percentage of the amount needed for
saturation at the same temperature.

What needs to be checked during inprocess QA checks?

A. a.) Environmental Monitoring
b.) Measured values obtained from the process equipment
(ex:temperature,RPM etc.)
c.) Measured values obtained from persons (ex:timmings,entries
etc.)
d.) Process attributes (Ex:weight,hardness,friability etc.)