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.
 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. 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 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.

15. 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.

16. Types of HPLC Pumps:

There are 3 main types of HPLC Pumps : Reciprocating pump, Displacement (or syringe) pump and
Pneumatic (or constant pressure) pump.

17. 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.

18. 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.

19. 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.

20. 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.

21. What is Karl Fischer Titration:

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

22. 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. 

23. 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.

24. 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.

25. 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.

26. 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.

27. 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.

28. 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.

29. 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.

30. Design Qualification : 

Documented verification that equipment, instrument, facility and system are of suitable design against the
URS and all key aspects of design meet user requirements.

31. Installation Qualification (IQ) :

The documented verification that all components of the equipment and associated utilities are properly
installed or modified in accordance with the approved design and manufacturer’s recommendations.

32. Operational Qualification : 

Operational qualification consists of verification and documentation, of the parameters of the subjected
equipment. The documented verification that the equipment, instrument, facility and system as installed or
modified, perform as intended throughout the installed operating range.

33. Performance Qualification :

Performance Qualification is designed to prove the process, can consistently produce a product that meets the
stated requirements and specifications. It is a documented verification that the equipment, instrument, facility
and system as connected together, can perform effectively and reproducibly, based on the approved process
method and product specification.

34. Why Three consecutive batches taken for Validation :

Consecutive meaning following closely with no gap or following one after another without interruption.

 The number of batches to be taken under validation depends upon the risk involved in the manufacturing
Critical process parameters & critical Quality Attribute so  depends upon that manufacturer have to choose
the number of batches to be validated.
 If we will consider less than two batches then the data will not be sufficient for evaluation of and to prove
reproducibility of data  between batch to batch variation & if we consider more than three batches it can
increase the time & cost of manufacturer which usually not preferred.
 Generally if we will require quality in the First batch, then it is accidental (co-incidental), Second batch
quality is regular & third batch quality is Validation or Confirmation.

Statistical evaluation cannot be done by considering two points, because two points always draw a straight
line so minimum three points required for comparison of data.