Top 94 Quality Control Interview Questions and Expert Answers
Q1. 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 sometime 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.
Q2. 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 39ºC.
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.
Q3. What is 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 required to comply with test
Q4. What is 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 gelatine capsule DT 30 min as per BP & USP.
Q5. 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.
Q6. 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.
Q7. 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.
Q8. 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.
Q9. 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 go out of
limit etc. Deviations are of three types minor, major and critical.
Q10. What is change control?
It is an 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.
Q11. 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).
Q12. 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
analysed.
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.
Q13. What is difference between Stationary Phase and 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.
Q14. 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.
Q15. 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.
Q16. 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.
Q17. 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.
Q18. 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.
Q19. Types of HPLC pumps?
There are 3 main types of HPLC pumps: Reciprocating pump,
Displacement (or syringe) pump and Pneumatic (or constant pressure) pump.
Q20. What is trailing factor?
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 centre line of the peak to the front
slope, with all measurements made at 5% of the maximum peak height.
Q21. 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.
Q22. 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.
Q23. 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.
Q24. 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.
Q25. 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
analysed by HPLC or ultraviolet–visible spectroscopy.
Q26. 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.
Q27. 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.
Q28. What is gas chromatography?
Gas chromatography is a common type of chromatography which
is used for separating and analysing 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.
Q29. 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.
Q30. 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 / iodide reaction and 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.
Q31. 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.
Q32. 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.
Q33. 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.
Q34. 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 product X 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 product X current result is 97.5 % so in this case it is
called OOT.
Q35. 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.
Q36. 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 is 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).
Q37. 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.
Q38. In stability how many conditions are there?
There are three stability condition long term or controlled
room temperature (CRT), accelerated and intermediate.
Q39. 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.
Q40. 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.
Q41. 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.
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 quantified with
acceptable accuracy and precision.
Q42. Define pH? What is the pH of the blood?
pH is the negative logarithm of H+ Concentration. The pH of
the blood ranges from 7.35 to 7.45.
Q43. Explain the terms aliquot and diluent?
Aliquot: Aliquot is a measured sub-volume of the original
sample.
Diluent: the component used to dilute the sample.
Q44. Explain what is titration?
Titration is also called volumetric analysis. It is a
quantitative chemical analysis used to determine the concentration of an
analyte that has been identified. The titrator is a reagent that is prepared as
a standard solution with a known concentration and volume. The titrant reacts
with the analyte solution to determine the concentration of the analyte. The
titration volume is the amount of titrant that reacts with the analyte.
Q45. Types of titrations?
There are basically four types of titrations, acid-base
titration, complexometric titration, precipitation titration, and redox
titration.
Q46. Explain the four types of titrations.
Acid-base titration: this acidic or basic titrant reacts
with an analyte that is a base or an acid.
Complexometric titrations: involving metal-ligand
complexation reactions
Precipitation titrations: When the analyte and titrant
react, a precipitate is formed.
Redox titrations: Where the titrant is oxidizing agents or
reducing agents.
Q47. What is the Ultraviolet (UV) and visible spectroscopy range?
The range of UV Spectroscopy is 200-400 nm, and visible
spectroscopy ranges from 400- 800 nm.
Q48. What is the use of UV Spectroscopy?
Spectroscopy can be used to detect functional groups, and
impurities, and perform qualitative and quantitative analyses.
Q49. What is meant by the solution?
A solution is a mixture of liquids, gases, and solids, the
solution consists of many different types of solutes like salts, oxygen, and
organic molecules.
Q50. Describe the saturated and unsaturated solutions
A saturated solution is defined as a solution in which a
solvent is not capable of dissolving any more solute at a given temperature.
At a given temperature, an unsaturated solution is one in
which the solvent is Capable of dissolving any extra solute.
Q51. What is the difference between qualitative and quantitative analysis?
Qualitative analysis involves the identification of the
compound or chemical based on their chemical (absorption, emission) or physical
properties, e.g., melting point and boiling point.
Quantitative analysis: this involves estimation or
determination of the concentration or amount of the chemical compounds or
components.
Q52. Explain the principle of ultraviolet spectroscopy?
Ultraviolet spectroscopy uses light in the UV part of the
electromagnetic spectrum. UV absorption spectra form when the outer electrons
of a molecule or an atom absorb energy and move from a lower to a higher energy
level. The wavelength absorbance of each molecule is unique.
Q53. Define Molarity?
A number of moles of solute per litre solution. molarity is
denoted with a capital “M”.
Q54. Define molality?
The number of moles of solute per kilogram solvent. it is
denoted with a small “m”.
Q55. Define normality?
The number of moles equivalent per litre solution.
Q56. What are buffer solutions?
A buffer solution is an aqueous solution consisting of a
mixture of a weak acid and its conjugate base or vice versa.
When a minimal amount of strong acid or base is introduced
to it, the pH changes ve-ry little.
Q57. What is valency?
Valency is simply the combining power of elements. the
valency determines the chemical formula of a compound. When compounds react to
form new compound (s) they tend to change their valences.
Q58. What is aqua regia?
A mixture of concentrated nitric acid and hydrochloric acids
(1:3). It’s a highly corrosive liquid that can harm gold and other hardened
materials.
Q59. What is bleaching powder’s chemical name?
Calcium hypochlorite, also known as CaOCl2, is an inorganic
chemical compound having the formula CaOCl2. Calcium oxychloride is another
name for them.
Q60. What is polarity?
Polarity is the electronegativity difference between the
atom or molecule or the ability of an atom to attract shared electrons in a
covalent bond.
Example: Water is a good example of a polar molecule due to
the difference in electronegativity between the oxygen atom and the hydrogen.
Oxygen is a highly electronegative atom compared to hydrogen. Because fats,
petrol, and gasoline do not dissolve in water, they are classified as non-polar
molecules. Nonpolar means “insoluble in water.”
Q61. Explain the beer lamberts law?
It states that the intensity of nonchromatic 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.
Q62. What is an indicator in chemistry?
Indicators are substances that show a change in colour when
brought in contact with acid or base. The most commonly used indicators are
litmus, methyl orange, and phenolphthalein which change colour as follows.
Indicator Acid
Solution Basic Solution Neutral Solution
Blue Litmus Solution Red No change in colour No change in colour
Red Litmus Solution No
change in colour Blue No change in colour
Methyl Orange Red Yellow Orange
Phenolphthalein Colourless Red Colourless
Q63. Explain the infrared spectroscopy principle?
When a molecule absorbs infrared radiation, it vibrates and
gives rise to a packed infrared absorption spectrum. This IR spectrum is
specific for every different molecule absorbing the IR radiation, useful for
identification.
Q64. What is the common alum?
Potassium alum, potash alum, or potassium aluminium sulphate
is a chemical compound Chemical formula of common alum is KAI(SO4)2.12H2O. Use
water purification.
Q65. What is a covalent bond?
A covalent bond also called a Molecular bond is a chemical
bond that involves the sharing of electron pairs between atoms.
Q66. Mention the formula to calculate the pH of a solution?
Formula to calculate pH = -log [H+] or pH = -log [H3O+]
Q67. What is PPM?
PPM is parts per million (such as % means parts per 100)
Q68. What is the HPLC principle?
It’s a technology used for separating the mixture of
compounds into individual components based on absorption, partition, ion
exchange, and size exclusion principles. The stationary phase and mobile phase
are used in it. HPLC is used for the identification, quantification, and
purification of components from a mixture.
Q69. Explain what is dextro-rotatory and laevorotatory?
Laevorotation and Dextrorotation are referred to as the
properties of plane-polarized light when light rotates clockwise when it
approaches the observer then known as dextro-rotatory, and when light rotates
anticlockwise then it’s referred to as laevorotatory.
Q70. Difference between humidity and relative humidity?
Humidity – Measure of amount of water vapour present in the
atmosphere.
Relative humidity – Water vapour amount exists in air
expressed as a percentage of the amount needed for saturation at the same
temperature.
Q71. What is dissolution?
Dissolution is nothing but the time required to dissolve the
active drug substance into a medium in a given set of conditions.
Q72. What is a stability chamber?
Stability chambers are the chambers to store the stability
sample at different storage conditions to understand the impact of the
different climatic conditions on the drug substance or drug product.
Q73. What is a significant change as per ICH?
According to ICH significant change in the drug product is
defined as;
1. A 5%
change in assay from the initial value; or failure to meet the acceptance
criteria for potency when using biological or immunological procedures.
2. Any
degradation product exceeding its acceptance criterion.
3. Failure
to meet acceptance criteria for appearance, physical attributes, and
functionality test, (e.g., colour, phase separation, resuspendibility, caking,
hardness, dose delivery per actuation). However, some changes in physical
attributes, (e.g., softening, suppositories, melting of creams) may be expected
under accelerated conditions.
4. Failure
to meet acceptance criterion for pH.
5. Failure
to meet the acceptance criteria for dissolution for 12 dosage units.
Q74. What is the stability guideline as per ICH?
According to ICH, Q1 is a Stability guideline. Q75. Total
how many ICH quality guidelines? Total 14 quality guidelines as per ICH.
Q76. What are the 14 ICH quality guidelines?
ICH Q1- Stability
ICH Q2- Analytical Validation ICH Q3- Impurity
ICH Q4- Pharmacopeia
ICH Q5- Quality of Biotechnological Product ICH Q6-
Specification
ICH Q7- Good Manufacturing Practices ICH Q8- Pharmaceutical
Development ICH Q9- Quality Risk Management
ICH Q10- Pharmaceutical Quality System
ICH Q11- Development and Manufacture of drug substances ICH
Q12- Lifecycle Management
ICH Q13- Continuous Manufacturing of drug substances and
drug products ICH Q14- Analytical Procedure Development
Q77. How many types of dissolution as per USP?
Total 7 types of dissolution as per USP.
Q78. What are the 7 apparatus of dissolution as per USP?
Apparatus 1 – Basket
Apparatus 2 – Paddle
Apparatus 3 – Reciprocating cylinder (Not accepted by
Japanese Pharmacopoeia) Apparatus 4 – Flow through cell
Apparatus 5 – Paddle over a disc Apparatus 6 – Rotating
cylinder Apparatus 7 – Reciprocating Disc
Q79. What is S1, S2, and S3 as per USP?
The dissolution test is performed in three stages that are
S1, S2, and S3.
Q80. What is dissolution acceptance criteria as per USP?
Stage No. of Units to be tested Acceptance criteria
S1 6 No unit is less than Q+5%
S2 6 An average of 12 units (S1+S2) is equal to or greater than Q, and no unit is less than Q-15%
S3 12 An average of 24 units (S1+S2+S3) is equal to or greater than Q, and not more than 2 units are less than Q-15% and no unit is less than Q-25%
Q81. Why KBr used in IR?
1. KBr is an
inactive substance in IR range.
2. KBr
dipole moment is zero.
3. KBr is a
temperature stable substance.
Q82. Why is water not used in IR spectroscopy?
1. Water is
a strong polar solvent.
2. In the IR
region water shows two strong peaks.
Q83. What is a correction?
Any repair, modification, adjustment, relabelling,
destruction or inspection of a combination product without its physical removal
from its point of use to some other location.
Q84. What is recall?
Recall is an action to remove of specific products or
batches of the product from the market.
Q85. What is mock recall?
Tracing specific batches of the product in the market to
access the preparedness and efficacy of the distributor/carry and forwarding
agents/global distribution centre to get back details of the product in the
shortest possible time.
Q86. What are quality defects in pharmaceutical?
Attributes of the medicinal product or component (which may
affect the quality, safety, and efficacy of the product) which are not in line
with the approved product specifications.
Q87. What is the full form of NDA, ANDA, and IND?
NDA- New Drug Application
ANDA- Abbreviated New Drug Application IND- Investigational
New Drug
Q88. What is 21 CFR?
21 CFR is Code of Federal Regulation Title 21 which
represents “Food and Drugs”.
Q89. What is data integrity?
Data integrity is the complete, consistent, and accuracy of
the data throughout the lifecycle.
Q90.What is audit trail?
Audit trail is nothing but secure, time-stamped,
computer-generated electronic records that allows for reconstruction of the
course of events relating to the creation, modification or deletion of
electronic records. It is a chronological record of the activity that happened
such as what, when, why, where etc.
Q91. What is 21 CFR part 11?
FDA 21 CFR Part 11 represents “Electronic signature and
Electronic Records”
Q92. What is validation?
Validation is a process of establishing documentary evidence
demonstrating that a process, procedure or activity carried out in the testing
and then production maintains the desired level of compliance at all stages.
OR
Process validation is defined as the collection and
evaluation of data from the process design stage throughout the production,
that establishes the scientific evidence that a process is capable to produce
consistently delivering quality products.
Q93. What are the types of validation?
I. Prospective
Validation
II. Retrospective
Validation
III. Concurrent
Validation
IV. Revalidation
94. What is Alcoa Plus?
Alcoa plus is an acronym of A- Attributable
L- Legible
C- Contemporaneous O- Original
A- Accurate C- Complete C- Consistent E- Endurance A-
Available
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