Introduction & Validation of Analytical Procedures Flashcards
COMMON MANUFACTURING ERRORS
-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
Something that was not supposed to
be added to the drug or medical
device may have gotten in during the
manufacturing process.
Contamination of
the Drug/ Medical
Device
The medication may be stronger or
weaker than it was designed.
Wrong Dose of Drug
The label may be missing crucial
information or may be the wrong
label for the medication or medical
device.
Wrong Label Being
Put on the Drug/
Medical Device
A part could be broken or missing
A Medical Device
that is not Designed
According to an
Approved Plan
-Controlled from start to finish
-May deviate from the standard → analysis are done →
quality of analysis is checked
QUALITY OF A PRODUCT
time at which product is at least 90%
effective
Shelf-life -
T/f : Quality control means Testing of products throughout their shelf-life
True
Provides the criteria that are used to judge the quality of an
analysis
PHARMACEUTICAL ANALYSIS
PHARMACEUTICAL ANALYSIS is the control of ______________, ______________ and the validation of _______
-Control of analytical quality
-Control of errors in analysis
-Validation of analytical procedures
VALIDATION USP
1225
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.
VALIDATION
a planned series of interactive tests and inspection
designed to describe and reduce uncertainty in an
important process
Validation
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
PROCESS VALIDATION
this describes how things are done
PROCESS VALIDATION
refers to the way of performing the analysis.
VALIDATION OF ANALYTICAL PROCEDURE
T/F: VALIDATION OF ANALYTICAL PROCEDURE should describe in detail the steps necessary to perform
each analytical test
True
It is to demonstrate that it is suitable for its intended
purpose (ICH Guidelines)
VALIDATION OF ANALYTICAL PROCEDURE
Common Types of Analytical Procedures
Assay, Identification Tests, Testing for impurities
most common (e.g. detecting amount of active
ingredient used)
Assay
to identify whether it is the target
product
Identification Tests
(identification) Ensure the identity of the analyte
SPECIFICITY
(Purity Test) allow an accurate statement of the content of
impurities of an analyte
SPECIFICITY
(Assay) provide an exact result on the content or potency of
an analyte in the sample
SPECIFICITY
Nearness to the true value
ACCURACY
Accuracy should be assessed using a minimum of ____________
9
determinations (minimum of 3 concentration in triplicate)
T/F: accuracy is usually compared with the standard (USP)
true
levels of precision
Repeatability, Intermediate, Reproducibility
Minimum of 9 determinations; 3
different concentrations in triplicate
Repeatability
Minimum of 6 determinations at 100%
of the test concentration
Repeatability
Laboratory variations; different days, analysts and/or equipment
Intermediate
It is performing the tests between
laboratories
Reproducibility
The lowest amount of analyte in a sample that can be
detected but not quantified by test methods
DETECTION LIMIT (LOD)
The lowest amount of analyte in a sample that can be
quantified in the sample
QUANTITATION LIMIT (LOQ)
The method must be able to produce results that are
directly proportional with the concentration of analyte in
the sample
LINEARITY
A minimum of ________ concentration is recommended for linearity
5
It is the interval between the upper and lower
concentration of analyte in the sample
RANGE
A measure of its capacity to remain unaffected by small
deliberate variations in method parameters
ROBUSTNESS
(Category) Analytical procedure for quantification
of major component of bulk drug
substances or active ingredients
(including preservatives) in finished
pharmaceutical products
Category I
(Category) Analytical procedures are for
determination of impurities in bulk drug
substances or degradation compounds
in finished pharmaceutical products
Category II
Category II include
quantitative
assays and limit tests
(Category) Analytical procedures for determination
of performance characteristics (e.g.,
dissolution, drug release, and others)
Category III
Identification tests
Category IV
