Professional Documents
Culture Documents
succeed. You can also turn the question back to the interviewer, and ask where they see the
company in five years. You might not know on a personal level where you'll be, but most
companies have goals and plans that look ahead two to five years. Their answer might give you a
good idea if it's a company worth sticking around that long for.
5. "Tell me about a time you failed."
Everyone has failed, so don't play dumb or claim you've never messed up. Think of a time when a
work-related situation didn't turn out quite as you had hoped. An interviewer is interested in
seeing how you took responsibility foryour failure, what you learned from it, and how you would
prevent similar failures from happening again.
Examples:
"I once rushed a project to make a shipping deadline but inadvertently skipped a couple of critical
steps. Fortunately we discovered the mistake before the customer installed the products, but they
weren't pleased. I never made that mistake again."
"I thought my aggressive sales tactics were a great quality until I lost a client for being too pushy.
I've since learned to tone things down and really listen to my clients and understand their needs
before determining how to help them."
criterion
for appearance,physical
Sealing temperature
Check & quarantine the isolated quantity of packed goods from last
passed inprocess.
Blisters from the leak test passed containers shall allow to go further
and rest must be deblistered/defoiled accordingly.
2.
Tablet hardness
3.
of
same
product
Evaluating
Largest
and
smallest
Fastest and slowest operating speeds
What
is
Validation?
the
difference
between
fill
extremes
volumes
calibration
and
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.
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.
What
'0' size
Water
for
metals why ?
pharmaceutical
use
shall
be
free heavy
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.
Forced
degradation
stability testing
(stress
testing)
Vs accelerated
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 10C increments (e.g., 50C, 60C)
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.
According
the
storage
What
of
air
changes/hour
in
an
area
is
Then find Total air flow. Formula is as followTotal Air flow = Sum of air flow of individual filter.
Air flow Velocity can be measured with the help of Anemometer.
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.
What
dispersible tablet?
25 10C (IP) & 15 250C (BP)
What
DT
What
Non-viable count
Microbial monitoring
What
is
Validation?
the
difference
between
calibration
and
12.DefineprocessflowofTabletmanufacturing?
13.DefineprocessflowofSterileLyophilizedmanufacturing?
14.DefineprocessflowofBiotechproductmanufacturing?
3.Moisture content
Q. Which type of tablets are exempted from Disintegration testing?
Ans: Chewable Tablets
Q. What is the recommended temperature for checking DT of a dispersible tablet?
Ans: 25 10C (IP) & 15 250C (BP)
Q. List out the appearance defects of tables during compression activity ?
1.
Capping:- Capping is the term used, when the upper or lower segment of
in the granulation.
4.
Cracking:- Small fine cracks observed on the upper and lower center
surface of the tablets, or very rarely on the side wall are referred to as
cracks.
5.
colour on a tablet.
7.
Limit
USP
80 mg or less
10%
130mg or less
130mg to 324mg
250mg or more
5%
Limit
Q. If sticking observed during tablet compression what may the probable reason for the same?
10%
Ans: 1.If the granules are not dried properly sticking can occur.
300mg or More
7.5%
4.Hygroscopic granular
Q. What is the difference between calibration and validation?
Ans: 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.
Ans: In an elixir, the active ingredients are mixed with a liquid, usually a kind of syrup or alcohol, in
which they can dissolve.
In a suspension, the medicine is mixed with a liquid, usually water, in which it cannot dissolve and
therefore remains intact in the form of small particles. The important thing to remember is that you
have to shake a suspension before giving each dose so that the medicine particles are evenly
distributed throughout the liquid.
Ans: Design Qualification (DQ): documented verification that the proposed design of the facilities,
equipment, or systems is suitable for the intended purpose.
Installation Qualification (IQ): documented verification that the equipment or systems are installed or
modified & comply with the approved design of the manufacturers recommendations and/or user
requirements.
Operational Qualification (OQ): documented verification that the equipment or systems are installed or
modified & perform as intended throughout the anticipated operating ranges.
Performance Qualification (PQ): documented verification that the equipment and ancillary systems are
connected & can perform effectively and reproducibly based on the approved process method and
specifications.
Ans: Heating, Ventilating and Air conditioning system is used for temperature and humidity control
within a manufacturing environment. It includes air handling units, air distribution network, air-cooling
and heating system, air filtration, equipment control system, monitoring and alarm decreases
A room in which the concentration of airborne particles is controlled to meet specified airborne
particulate cleanliness class. In addition, the concentration of microorganisms in the environment is
monitored; is cleanliness class defined is also assigned a microbial level for air, surface, and
personnel gear.
Aseptic Area
Any area in an aseptic process system for which airborne particulate and microorganism levels are
controlled to specific levels appropriate to the activities conducted within that environment.
Microbial Contamination-Total viable aerobic count should less than 10 micro-organism per
100 ml. Absence of E.
Q. Accurately weigh an amount of Lithum Citrate USP (Containing 2.5% moisture as stated in
certificate of analysis) to obtain 200 mEq of Lithium. (Note: 1 mEq Lithium is equivalent to
0.00694 gm of Lithium)
Ans:
B= 282 g/mole
D= 0.975
Ans:
o
Propellant
Container
Product concentrate
S g. = 100 ml ,
X = 4000 ml
Q. Peppermint spirit contains 10% (v/v) of peppermint oil. What volume of spirit contain 75 ml of active
ingredient ?
Ans.
Ointment
Cream
Thick
Thin
Q. What s Vortex?
Ans. In fluid dynamics, a vortex is a region within a fluid where the flow is mostly a spinning motion
about an imaginary axis, straight or curved.
Ans.
WET GRANULATION
DRY GRANULATION
DIRECT
COMPRESSION
1.
Milling
and mixing of drugs and excipients
1.
Milling
and mixing of drugs
and excipients
2.
Preparation
of binder solution
2.
Compression
into slugs or roll compaction
2.
Compression of tablet
3.
Wet
massing by addition of binder solution
or granulating solvent
3.
Milling
and screening of slugs and
compacted powder
4.
Screening
of wet mass
4.
Mixing
with lubricant and disintegrant
5.
Drying
of the wet granules
5.
Compression
of tablet
6.
Screening
of dry granules
7.
Blending
with lubricant and disintegrant to
produce running powder
8.
Compression
of tablet
Ans.
1.Physical Method
b.Radiation method
c.Filtration method
2.Chemical Method
a. Gaseous method
Ans. BFS means Blow Fill Seal. This technology usually used for sterilized product like ophthalmic
drops, where container preparation, material fill and sealing all are happen at a time.
Acid source;
Alkaline compound, constituted by a carbonate or bicarbonate
Q. What is Lyophilization?
Ans: Lyophilization, or freeze drying, there is a water is frozen, followed by its removal from the
sample, initially by sublimation (primary drying) and then by desorption (secondary drying). In this
process, the moisture content of the product is reduced to such a low level that does not support
biological growth or chemical reactions which gives the stability to the formulation. This technique
useful in formulation development of drugs which are thermolabile and/or unstable in aqueous
medium.
Ans: The primary packaging consist of those packaging components which have a direct contact with
the product (i.e. bottle, cap, cap liner, label etc).
The secondary packaging mainly provides the additional physical protection necessary to endure the
safe warehousing and for refill packaging.
Ans. Strip packages have at least one sealed pocket of material with each pocket containing a single
dose of the product. The package is made of two layers of film or laminate material. The nature and
level of protection which is required by the contained product will affect the composition of these
layers.
Blister packages are composed of a base layer, with cavities called blisters which contain the
pharmaceutical product, and a lid. This lid is sealed to the base layer by heat, pressure or both. They
are more rigid than strip packages and are not used for powders or semi-solids. In tropical areas
blister packages with an additional aluminium membrane is used which provide greater protection
against high humidity.
Q. PEG is . surfactant.
A. anionic
C. non anionic
D. cationic
A. 70%
B. 60%
C. 50%
D. 40%
A. Alcohol
B. Glycerine
C. Sufactant
D. Emulsion
A. Glutathemide
B. Paraldehyde
C. Chlorambucil
D. Chloral hydrate
A. Oxidation
B. Hydrolysis
C. Saponification
D. Neutralisation
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 ?
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
USP
130mg or less
130mg to 324mg
More than 324mg
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 (Dont 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.
2.)
of AHU system.
Q. What needs to be checked during AHU validation?
A. During AHU validation, following tests shall be carried out
Non-viable count
Microbial monitoring
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.
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
Phase - 3
Phase 3 runs for one year after satisfactory completion of phase2.Water can be used for manufacturing process during this process.
Objectives & Features of Phase -3
Climatic Zone
Zone I
Zone II
Zone III
Zone IV
Zone IVb
Refrigerated
Frozen
Temperature
21C 2C
25C 2C
30C 2C
30C 2C
30C 2C
5C 3C
-15C 5C
Humidity
Minimum
Duration
45% rH 5% rH 12 Months
60% rH 5% rH 12 Months
35% rH 5% rH 12 Months
65% rH 5% rH 12 Months
75% rH 5% rH 12 Months
No Humidity
12 Months
No Humidity
12 Months
Milling conditions
Tablet hardness