Introduction & Validation of Analytical Procedures

Question 1

COMMON MANUFACTURING ERRORS

Answer 1

-Contamination of
the Drug/ Medical
Device
-Wrong Dose of Drug
-Wrong Label Being
Put on the Drug/
Medical Device
-A Medical Device
that is not Designed
According to an
Approved Plan

Question 2

Something that was not supposed to
be added to the drug or medical
device may have gotten in during the
manufacturing process.

Answer 2

Contamination of
the Drug/ Medical
Device

Question 3

The medication may be stronger or
weaker than it was designed.

Answer 3

Wrong Dose of Drug

Question 4

The label may be missing crucial
information or may be the wrong
label for the medication or medical
device.

Answer 4

Wrong Label Being
Put on the Drug/
Medical Device

Question 5

A part could be broken or missing

Answer 5

A Medical Device
that is not Designed
According to an
Approved Plan

Question 6

-Controlled from start to finish
-May deviate from the standard → analysis are done →
quality of analysis is checked

Answer 6

QUALITY OF A PRODUCT

Question 7

time at which product is at least 90%
effective

Answer 7

Shelf-life -

Question 8

T/f : Quality control means Testing of products throughout their shelf-life

Answer 8

True

Question 9

Provides the criteria that are used to judge the quality of an
analysis

Answer 9

PHARMACEUTICAL ANALYSIS

Question 10

PHARMACEUTICAL ANALYSIS is the control of ______________, ______________ and the validation of _______

Answer 10

-Control of analytical quality
-Control of errors in analysis
-Validation of analytical procedures

Question 11

VALIDATION USP

Answer 11

1225

Question 12

defined as the verification, by data and analysis, that the
design objectives of a given facility, system, apparatus, or
procedures are reliably fulfilled in routine operation.

Answer 12

VALIDATION

Question 13

a planned series of interactive tests and inspection
designed to describe and reduce uncertainty in an
important process

Answer 13

Validation

Question 14

a documented program which provides a high degree of
assurance that a specific process will consistently produce
a product meeting its predetermined specification and
quality attributes

Answer 14

PROCESS VALIDATION

Question 15

this describes how things are done

Answer 15

PROCESS VALIDATION

Question 16

refers to the way of performing the analysis.

Answer 16

VALIDATION OF ANALYTICAL PROCEDURE

Question 17

T/F: VALIDATION OF ANALYTICAL PROCEDURE should describe in detail the steps necessary to perform
each analytical test

Answer 17

True

Question 18

It is to demonstrate that it is suitable for its intended
purpose (ICH Guidelines)

Answer 18

VALIDATION OF ANALYTICAL PROCEDURE

Question 19

Common Types of Analytical Procedures

Answer 19

Assay, Identification Tests, Testing for impurities

Question 20

most common (e.g. detecting amount of active
ingredient used)

Answer 20

Assay

Question 21

to identify whether it is the target
product

Answer 21

Identification Tests

Question 22

(identification) Ensure the identity of the analyte

Answer 22

SPECIFICITY

Question 23

(Purity Test) allow an accurate statement of the content of
impurities of an analyte

Answer 23

SPECIFICITY

Question 24

(Assay) provide an exact result on the content or potency of
an analyte in the sample

Answer 24

SPECIFICITY

Question 25

Nearness to the true value

Answer 25

ACCURACY

Question 26

Accuracy should be assessed using a minimum of ____________

Answer 26

9
determinations (minimum of 3 concentration in triplicate)

Question 27

T/F: accuracy is usually compared with the standard (USP)

Answer 27

true

Question 28

levels of precision

Answer 28

Repeatability, Intermediate, Reproducibility

Question 29

Minimum of 9 determinations; 3
different concentrations in triplicate

Answer 29

Repeatability

Question 30

Minimum of 6 determinations at 100%
of the test concentration

Answer 30

Repeatability

Question 31

Laboratory variations; different days, analysts and/or equipment

Answer 31

Intermediate

Question 32

It is performing the tests between
laboratories

Answer 32

Reproducibility

Question 33

The lowest amount of analyte in a sample that can be
detected but not quantified by test methods

Answer 33

DETECTION LIMIT (LOD)

Question 34

The lowest amount of analyte in a sample that can be
quantified in the sample

Answer 34

QUANTITATION LIMIT (LOQ)

Question 35

The method must be able to produce results that are
directly proportional with the concentration of analyte in
the sample

Answer 35

LINEARITY

Question 36

A minimum of ________ concentration is recommended for linearity

Answer 36

5

Question 37

It is the interval between the upper and lower
concentration of analyte in the sample

Answer 37

RANGE

Question 38

A measure of its capacity to remain unaffected by small
deliberate variations in method parameters

Answer 38

ROBUSTNESS

Question 39

(Category) Analytical procedure for quantification
of major component of bulk drug
substances or active ingredients
(including preservatives) in finished
pharmaceutical products

Answer 39

Category I

Question 40

(Category) Analytical procedures are for
determination of impurities in bulk drug
substances or degradation compounds
in finished pharmaceutical products

Answer 40

Category II

Question 41

Category II include

Answer 41

quantitative
assays and limit tests

Question 42

(Category) Analytical procedures for determination
of performance characteristics (e.g.,
dissolution, drug release, and others)

Answer 42

Category III

Question 43

Identification tests

Answer 43

Category IV