1. What is an SOP ?

A Standard Operating Procedure (SOP) is a certain type of document that describes in a step-by-
step outline form how to perform a particular task or operation. Everyone in a company must
follow the same procedures to assure that tasks are performed consistently and correctly. Most
companies have a wide variety of SOPs that describe how to do different tasks. In many
companies technicians and operators are trained in how to follow individual SOPs and their
training record specifies which SOPs they are trained on and are authorized to use.

2. What is 21 CFR part 11 ?

Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug
Administration (FDA) guidelines on electronic records and electronic signatures in the United
States. Part 11, as it is commonly called, defines the criteria under which electronic records and
electronic signatures are considered to be trustworthy, reliable and equivalent to paper records

3. What are user requirements ?

User Requirements Specification describes what users require from the System. User
requirement specifications are written early in the validation process, typically before the system
is created. It is written by the System Owner and End Users, with input from Quality Assurance.
Requirements outlined in the URS are usually tested in the Performance Qualification. User
Requirements Specifications are not intended to be a technical document; readers with only a
general knowledge of the system should be able to understand the requirements outlined in the
URS.

4. What is a validation plan ?

Validation Plans define the scope and goals of a validation project. Validation plans are written
before a validation project and are specific to a single validation project. Validation Plans can
include:

Deliverables (Documents) to be generated during the validation process

Resources/Departments/Personnel to participate in the validation project
Time-Line for completing the validation project

5. What is an IQ document ?

Installation Qualifications are a collection of test cases used to verify the proper installation of a
System. The requirement to properly install the system was defined in the Design Specification.
Installation Qualifications must be performed before completing Operational Qualification or
Performance Qualification.
6. What is an OQ Document?

Operational Qualifications are a collection of test cases used to verify the proper functioning of a
System. The operational qualification tests requirements defined in the Functional Requirements.
Operational Qualifications are usually performed before the system is released for use.

7. What is a PQ Document?

Performance Qualifications are a collection of test cases used to verify that a System performs as
expected under simulated real-world conditions. The performance qualification tests
requirements that were defined in the User Requirement Specification (or possibly the Functional
Requirements). Due to the nature of performance qualifications, these tests are sometime
conducted with power users as the system is being released.

8. What is a Validation Summary Report ?

Validation Summary Reports provide an overview of the entire validation project. When
regulatory auditors review validation projects, they typically begin by reviewing the summary
report. The validation summary report should include:

A description of the validation project

All test cases performed, including if those test cases passed without issue
All deviations reported, including how those deviations were resolved

9. What is a Change Request ?

Change Control is a general term describing the process of managing how changes are
introduced into a controlled System. In validation, this means how changes are made to the
validated system. Change control is required to demonstrate to regulatory authorities that
validated systems remain under control after system changes. Change Control systems are a
favorite target of regulatory auditors because they vividly demonstrate an organization capacity
to control its systems.

Q. Why water for pharmaceutical use is always kept in close loop in continuous
circulation ?
A. Water is a best medium for many microorganisms, microorganism can be a highly pathogenic
which causes serious diseases(many diseases are water born), these pathogens infect after
consumption of contaminated water, microorganisms tend to settle on a surface if water is
allowed to stand in a stagnant position for few hours, these settled microorganism form a film
over the surface of vessel and piping, such film formed by microorganisms is also called as
biofilm, biofilms are very difficult of remove, once a biofilm is formed at a particular point then
that point may form a biofilm again even after cleaning very easily as seed from this point is may
not completely get removed effectively.

Biofilms then can become a source of microbial contaminations; therefore purified water after
collection in a distribution system is always kept in a closed loop in a continuous circulation.
A continuous circulation is also not enough at some points, therefore it is aided with high
temperature range from 65 °C to 80°C, a minimum temperature of 65 °C is considered a self
sanitizing, but better assurance is obtained with a temperature of 80°C .

Purified water collected should be stored in a stainless still vessel which must facilitate
distribution to the point of use in a closed loop of continuous circulation, tank should be made of
corrosion free material of construction, and must facilitate sanitization and easy cleaning.

Q. Water for pharmaceutical use shall be free cations,anions and other impurities why ?

A.Water for pharmaceutical must be free from inorganic as well as organic impurities, minerals,
and heavy metals. Some impurities like calcium, magnesium, ferrous are responsible for
degradation of drug molecule, many cations like ferrous and calcium magnesium act as catalysts
in degradation reaction of drug molecule, anions like chloride are highly active they participate
in nucliophylic substitution reactions, where in they break a double bond between -C=C- in to a
single bond as CL –CH-CH2- , which a reason why we observe that color dies tend to fed in
presence of chlorine as most of the dies used are diazo compounds which has plenty of places for
nucliophylic substitution reactions, which is also a reason why stability of drug is drastically
affected in presence of cations and anions from mineral origin present in water.

Q. Water for pharmaceutical use shall be free heavy metals why ?

A. Heavy metals like lead and arsenic are highly cumulative neurotoxic metals, heavy metals are
not eliminated out of our body easily like other drugs and molecules but heavy metals bind with
proteins and tend to get accumulated in fatty tissues, nerve tissue is most likely to get damaged
by heavy metals, heavy metal causes nervous tissue damage there for water must be free from
heavy metals.

Q. Brazil falls under which climatic zone ?

A. Zone IVB (30 degree celsius and 75% relative humidity)

Q. Change in the size or shape of the original container requires any stability study?
A. Change in the size or shape of the original container may not necessitate the initiation of new
stability study.

Q. Forced degradation(stress testing) and accelerated stability testing are same?

A. Forced degradation and stress testing are not same. Stress testing is likely to be carried out on
a single batch of the drug substance. The testing should include the effect of temperatures (in
10°C increments (e.g., 50°C, 60°C) above that for accelerated testing), humidity (e.g., 75 percent
relative humidity or greater) where appropriate, oxidation, and photolysis on the drug substance.
The testing should also evaluate the susceptibility of the drug substance to hydrolysis across a
wide range of pH values when in solution or suspension. Photo stability testing should be an
integral part of stress testing.

Q. According to WHO guidelines what is the storage condition of climatic zone IVa and
zone IVb?
A. Zone IV a: 30°C and 65% RH (hot and humid countries)
Zone IV b: 30°C and 75% RH (hot and very humid countries

Q. Countries comes under climatic zone IVb?

A.Brazil,Cuba,China,Brunei,Cambodia,Indonesia,Malaysia,Myanmar,Philippines,Singapore,Tha
iland

Q. What is the purpose of stress testing in stability studies?

A. Stress testing of the drug substance can help identify the likely degradation products, which
can in turn help establish the degradation pathways and the intrinsic stability of the molecule and
validate the stability indicating power of the analytical procedures used. The nature of the stress
testing will depend on the individual drug substance and the type of drug product involved.

Q. What is the formula for calculating number of air changes in an area?

A. Number of air changes/hour in an area is

= Total Room Airflow In CFM x 60

Total Volume of room in cubic feet
For calculating Total Room Airflow in CFM, first calculate air flow of individual filter. Formula
is given below.

Air flow (in cfm) = Avg.air velocity in feet/Minute x Effective area of filter

Then find Total air flow. Formula is

Total Air flow = Sum of air flow of individual filter.

Air flow Velocity can be measured with the help of Anemometer.

Q. What is dead leg?

A. A dead leg is defined as an area in a piping system where liquid can become stagnant and not
be exchanged during flushing.

Q. What is the recommended bio burden limits of purified water & WFI?
A. Purified water has a recommended bioburden limit of 100 CFU/mL, and water for injection
(WFI) has a recommended bio burden limit of 10 CFU/100 mL.
Q. Brief about ICH stabilty guidelines?
A. Q1A- Stability testing of new drug substance & products
Q1B- Photo stability testing of new drug substances & products
Q1C-Stability testing of new dosage forms
Q1D-Bracketing & Matrixing designs for testing of new drug substances and products
Q1E-Evaluation of stability data
Q1F-Stability data package for registration applications in climatic zone III & IV (Withdrawed)

Q. What is significant changes in stability testing?

A.
1. A 5% change in assay for initial value.

2. Any degradation products exceeds its acceptance criterion.

3. Failure to meet acceptance criterion for appearance,physical artributes and functionality

test.

4. Failure to meet acceptance criteria for dissolution for 12 units.

Q. If leak test fail during in process checks what needs to be done ?

A.
Immediately stop packing process and check for
1.Sealing temperature
2.Verify for any possible changes like foil width,knurling etc.
3.Check & quarantine the isolated quantity of packed goods from last passed inprocess.
4.Collect random samples & do retest.
5.Blisters from the leak test passed containers shall allow to go further and rest must be
deblistered/defoiled accordingly.

Q. How many Tablets shall be taken for checking friability?

A. For tablets with unit mass equal or less than 650 mg, take sample of whole tablets
corresponding to 6.5g.For tablets with unit mass more than 650mg,take a sample of 10 whole
tablets.

Q. What is the formula for calculating weight loss during friability test?
A. %Weight loss = Initial Weight - Final Weight X 100
Initial Weight

Q. What is the pass or fail criteria for friability test?

A. Generally the test is run for once.If any cracked,cleaved or broken tablets present in the tablet
sample after tumbling,the tablets fails the test.If the results are doubtful,or weight loss is grater
than the targeted value,the test should be repeated twice and the mean of the three tests
determined.A mean weight loss from the three samples of not more than 1.0% is considered
acceptable for most of the products.

Q. What is the standard number of rotations used for friability test?

A. 100 rotations

Q. What is the fall height of the tablets in the friabilator during friability testing?
A. 6 inches.Tablets falls from 6 inches eight in each turn within the apparatus.
Q. Why do we check hardness during inprocess checks?
A. To determine need for the pressure adjustments on the tableting machine. Hardness can affect
the disintegration time.If tablet is too hard, it may not disintegrate in the required period of
time. And if tablet is too soft it will not withstand handling and subsequent processing such as
coating,packing etc.

Q. What are the factors which influence tablet hardness?

A.
1.compression force
2.Binder quantity(More binder more hardness)
3.Moisture content

Q. Which type of tablets are exempted from Disintegration testing?

A. Chewable Tablets

Q. Which capsule is bigger in size - size '0' or size '1'?

A. '0' size

Q. What is the recommended temperature for checking DT of a dispersible tablet?

A. 25 ±10C (IP) & 15 – 250C (BP)

Q. What is mesh aperture of DT apparatus ?

A. 1.8 -2.2mm (#10)

Q. What is the pass/fail criteria for disintegration test?

A. If one or two tablets/capsules fails to disintegrate completely, repeat the test on another 12
additional dosage units. The requirement is meet if not fewer than 16 out of 18 tablets/capsules
tested are disintegrated completely.

Q. What is the recommended storage conditions for empty hard gelatin capsules?
A. 15 - 250C & 35 -55% RH

Q. Which method is employed for checking “Uniformity of dosage unit”?

A.
A.)Content uniformity
B.) Weight Variation
Weight variation is applicable for following dosage forms;Hard gelatin capsules,uncoated or film
coated tablets,containing 25mg or more of a drug substance comprising 25% or more by weight
of dosage unit.

Q. What is the recommended upward and downward movement frequency of a basket-

rack assembly in a DT apparatus?
A. 28 – 32 cycles per minute.

Q. When performing the ‘uniformity of weight’ of the dosage unit, how many
tablet/capsule can deviate the established limit?
A. Not more than two of the individual weights can deviates from the average weight by more
than the percentage given in the pharmacopeia,and none can deviates more than twice that
percentage.
Weight Variation limits for Tablets

IP/BP Limit USP

80 mg or less 10% 130mg or less
More than 80mg or Less than 250mg 7.5% 130mg to 324mg
250mg or more 5% More than 324mg

Weight Variation limits for Capsules

IP Limit
Less than 300mg 10%
300mg or More 7.5%
Q. 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.)

Q. What precautions shall be taken while collecting inprocess samples ?

A. While collecting inprocess samples, avoid contamination of the product being sampled (Don’t
collect samples with bare hands) & avoid contamination of sample taken.

Q. In a tablet manufacturing facility ‘positive’ pressure is maintained in processing area or

service corridors?
A. In tablet manufacturing facilities, pressure gradients are maintained to avoid cross
contamination of products through air. Usually processing areas are maintained under positive
pressure with respect to service corridors.

Q. If sticking observed during tablet compression what may the probable reason for the
same?
A.
1.If the granules are not dried properly sticking can
occur.
2.Too little or improper lubrication can also leads to
sticking.
3.Sticking can occur because of too much binder or
hygroscopic granular.

Q. What checks shall be carried out, while calibrating DT apparatus?

A. While calibrating DT apparatus, following checks shall be performed.
1.) Number of strokes per minute (Limit:29-32 cycles/min)
2.) Temperature by probe & standard thermometer (Limit: 37 ± 1 OC).
3). Distance travelled by basket (Limit:53 -57mm)

Q. What is In process checks?

A. In process checks are checks performed during an activity, In order to monitor and, if
necessary, to adjust the process to ensure that product confirms to its specification.

Q. What is the difference between disintegration and dissolution?

A. Disintegration is a disaggregation process, in which an oral dosage form falls apart in to
smaller aggregates.(Disintegration time is the ‘break up’ time of a solid dosage form).

Whereas dissolution is a process by which solid substance enters in the solvent to yield a
solution. It is controlled by the affinity between the solid substance and the solvent.

In other word disintegration is a subset of dissolution.

Q. Why do we calibrate a qualified equipment/instrument on definite intervals?

A. An equipment or instrument can ‘drift’ out of accuracy between the time of qualification and
actual use.So it is recommended to calibrate and recalibrate the measuring devices and
instruments on predetermined time intervals, to gain confidence on the accuracy of the data.

Q. Why do we consider three consecutive runs/batches for process validation? Why not two
or four?
A. The number of batches produced in the validation exercise should be sufficient to allow the
normal extent of variation and trends to be established and to provide sufficient data for
evaluation and reproducibility.
· First batch quality is accidental (co-incidental),
· Second batch quality is regular (accidental),
· Third batch quality is validation(conformation).
In 2 batch we cannot assure the reproducibility of data,4 batches can be taken but the time and
cost are involved.

Q. Explain about revalidation criteria of AHU system?

A. AHU system shall be revalidated periodically as mentioned in the regulatory standards. AHU
shall be revalidated in following cases also.
· When basic design of AHU is changed,
· When clean room volume is changed,
· When new equipment is installed
· When a construction is carried out, that calls for reconstruction of AHU system.

Q. What needs to be checked during AHU validation?

A. During AHU validation, following tests shall be carried out
· Filter efficiency test,
· Air velocity & number of air changes,
· Air flow pattern (visualization)
· Differential pressure, temperature and RH
· Static condition area qualification
· Dynamic condition qualification
· Non-viable count
· Microbial monitoring
· Area recovery and power failure study.

Q. Position of oblong tablets to be placed in hardness tester to determine the hardness?

Lengthwise / widthwise?
A. Position of oblong tablets should be length wise because the probability of breakage is more
in this position.

Q. Explain in detail about qualification of pharmaceutical water system?

A. Qualification of pharmaceutical water system involves three phases
· Phase -1
· Phase -2
· Phase -3
Phase -1
A test period of 2-4 weeks should be spent for monitoring the system intensively. During this
period the system should operate continuously without failure or performance deviation.Water
cannot be used for pharmaceutical manufacturing in this phase.The following should be included
in testing approach.
· Under take chemical & microbiological testing in accordance with a defined plan.
· Sample incoming feed water daily to verify its quality.
· Sample each step of purification process daily.
· Sample each point of use daily.
· Develop appropriate operating ranges.
· Demonstrate production and delivery of product water of required quantity and quality.
· Use and refine the SOP’s for operation,maintenance,sanitization and trouble shooting.
· Verify provisional alert and action levels.
· Develop and refine test failure procedure.

Phase -2
A further test period of 2-4 weeks. Sampling scheme will be same as Phase – 1.Water can be
used for manufacturing process in this phase.
Approach should also
· Demonstrate consistent operation within established ranges.
· Demonstrate consistent production & delivery of water of required quality and quantity.

Phase - 3
Phase 3 runs for one year after satisfactory completion of phase-2.Water can be used for
manufacturing process during this process.

Objectives & Features of Phase -3

· Demonstrate extensive reliable performance.
· Ensure that seasonal variations are evaluated.
· The sample locations, sampling frequencies and test should be reduced to the normal
routine pattern based on established procedures proven during Phase -1 & phase - 2.

Q. What are the recommended environmental monitoring limits for microbial

contamination?

Q. What is the difference between calibration and Validation?

A. Calibration is a demonstration that, a particular
Instrument or device produces results with in specified limits by comparisons with those
produced by a reference or traceable standard over an appropriate range of measurements.

Where as Validation is a documented program that provides high degree of assurance that a
specific process, method or system consistently produces a result meeting pre-determined
acceptance criteria.

In calibration performance of an instrument or device is comparing against a reference standard.

But in validation such reference standard is not using.

Calibration ensures that instrument or measuring devices producing accurate results. Whereas
validation demonstrates that a process, equipment, method or system produces consistent results
(in other words, it ensures that uniforms batches are produced).

Q. Briefly explain about ICH climatic zones for stability testing & long term storage
conditions?
A.ICH STABILITY ZONES
Zone Type of Climate
Zone I Temperate zone
Zone II Mediterranean/subtropical zone
Zone III Hot dry zone
Zone IVaHot humid/tropical zone
Zone IVbASEAN testing conditions hot/higher humidity

Long term Storage condition

 Climatic ZoneTemperatureHumidity Minimum Duration
Zone I 21ºC ± 2ºC 45% rH ± 5% rH12 Months
Zone II 25ºC ± 2ºC 60% rH ± 5% rH12 Months
Zone III 30ºC ± 2ºC 35% rH ± 5% rH12 Months
Zone IV 30ºC ± 2ºC 65% rH ± 5% rH12 Months
Zone IVb 30ºC ± 2ºC 75% rH ± 5% rH12 Months
Refrigerated 5ºC ± 3ºC No Humidity 12 Months
Frozen -15ºC ± 5ºC No Humidity 12 Months

Q. What is bracketing & matrixing in stability testing?

A.Both Matrixing & Bracketing’s are reduced stability testing designs
Bracketing
The design of a stability schedule, such that only samples of extremes of certain design factors
(ex:strength,package size) are tested at all time points as in full design.The designs assumes that
the stability of any intermediate level is represented by the stability of extremes tested.
Matrixing
The design of a stability schedule, such that a selected subset of possible samples for all factor
combinations is tested at a specified time point.At a subsequent time point another subset of
samples for all factor combination is tested.The design assumes that the stability of each subset
samples tested represents the stability of all samples at a given time point.
There for a given time point other than initial & final ones not every batch on stability needs to
be tested.

Q.What are the common variables in the manufacturing of tablets?

A.
· Particle size of the drug substance
· Bulk density of drug substance/excipients
· Powder load in granulator
· Amount & concentration of binder
· Mixer speed & mixing timings
· Granulation moisture content
· Milling conditions
· Lubricant blending times
· Tablet hardness
· Coating solution spray rate

Q. Whether bracketing & validation concept can be applied in process validation?

A.Both Matrixing & Bracketing’s can be applied in validation studies.
Matrixing
Different strength of same product
Different size of same equipment
Bracketting - Evaluating extremes
Largest and smallest fill volumes
Fastest and slowest operating speeds
You can use the job interview questions below that ask Pharma QA supervisor. You can use these
questions to ask/answer by your self. These QA interview questions also can be used for job titles as
follows:

• QA analyst
• QA assistant
• QA engineer
• QA inspector
• QA manager
• QA specialist
• QA supervisor
• QA tester

1. Technical questions for Pharma QA supervisor

• What is your ISO 9001 experience at position: Pharma QA supervisor? Have you taken a company
through registration?

• What is your track record on ISO 9001 non conformities?

• What is thier experence with writing the QA Manual at position: Pharma QA supervisor?

• What is your experience in working with sampling plans at position: Pharma QA supervisor? Please
describe some of the standards.

• Provide your detail knowledge on data analysis?

• What is your SPC experience at position: Pharma QA supervisor? Where have you used it?

• What does SPC do? What computer programs have you used for SPC? What processes have you set up
with SPC. When sample size is 1 how do you determine the range?

• When sample size is 1 how do you determine the range for SPC?

• What audits have you been involved with at position: Pharma QA supervisor. What is important to
recognize when doing an audit? Why Audit?

• What is your experience with reliability at position: Pharma QA supervisor? What data distributions do
most reliability studies follow?

• What statistical software have you use?

2. Common interview questions for Pharma QA supervisor

You can use free samples of interview questions as follows for Pharma QA supervisor position:
• Please tell me a little about yourself?

• What are key tasks for Pharma QA supervisor?

• How to do each Pharma QA supervisor position task/function?

• How to control each task/function of Pharma QA supervisor?? Etc

• What are your strengths and weaknesses?

• Tell me about your last position and what you did?

• Where would you like to be in 3 years? 5 years?

• What made you choose to apply to Pharma QA supervisor?

• How to measure job performance of your position: Pharma QA supervisor?

• What is the most recent skill you have learned that related to Pharma QA supervisor?

• What tertiary qualifications have you attained that related to Pharma QA supervisor?
the interview questions below can be used for pharmaceutical positions such as:

1. Pharmaceutical manager;
2. Pharmaceutical assistant;
3. Pharmaceutical supervisor;
4. Pharmaceutical coordinator etc

Pharmaceutical interview answer tips

1. Are newspaper advertisements a good way to find a job in pharma sales?

2. What are the pros and cons of working at a small pharmaceutical company versus one of the biggies?

3. I am in college. What can I do to enhance my odds of being hired as a pharmaceutical sales

representative?

4. What is a typical day for a pharmaceutical sales representative?

5. How many sales calls are you required to make each day?

6. What are some of the things that you don’t like about being a pharmaceutical rep?

7. I think I want to be a pharmaceutical sales representative, but how can I

8. I’m willing to relocate for the right pharmaceutical sales

9. Will an MBA or other advanced degree improve my chances of being hired as

a pharmaceutical sales rep?
10. How important is the resume in landing a pharmaceutical sales job?

11. What is the best way to land a job in pharmaceutical sales?

12. Why do the drug companies give so many interviews; why does the process

13. I have been on several interviews but received no offers. What could I be doing wrong?

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.

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/m3of 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.