Chemistry Reference
In-Depth Information
6.9 decIsIon trees
In an attachment to the specifications guideline, several decision trees are included
to help determine appropriate courses of action to establish acceptance criteria.
These decision trees are excellent sources of protocol. Table 6.1 summarizes the
eight decision trees included in the guidance. Figures 6.1 and 6.2 show examples of
two of the decision trees: Figure 6.1 for establishing acceptance criteria for a speci-
fied impurity in a new drug substance, and Figure 6.2 for establishing identity, assay,
and enantiomeric impurity procedures for chiral new drug substances and products
containing chiral drug substances.
6.10 oos bAcKground
It seems to happen in every laboratory, sooner or later, no matter how good a job is
done validating the method, no matter how robust; inevitably a result is obtained
tAble 6.1
summary of decision tree Attachment to the guideline for setting
specifications and Acceptance criteria
decision tree
title
comments
1
Establishing Acceptance Criterion for
a Specified Impurity in a New Drug
Substance
Relevant batches are those from
development, pilot, and scale-up
studies.
2
Establishing Acceptance Criterion for
a Degradation Product in a New
Drug Product
Refers back to decision tree #1.
3
Establishing Acceptance Criterion for
Drug Substance Particle Size
Distribution
Helps to determine if acceptance
criterion for particle size is required.
4
Investigating the need to set
Acceptance Criteria for
Polymorphism in Drug Substances
and Drug Products
Establishes criteria or justification for
exclusion of test.
5
Establishing Identity, Assay, and
Enantiomeric Impurity Procedures
for Chiral New Drug Substances and
New Drug Products Containing
Chiral Drug Substances
Numerous footnotes that should be
consulted for more detail.
6
Microbiological Quality Attributes of
Drug Substance and Excipients
Establishes criteria or justification for
exclusion of test.
7
Setting Acceptance Criteria for Drug
Product Dissolution
Justification for dissolution versus
disintegration; acceptance criteria for
single versus multiple-point rate
release profiles.
8
Microbiological Attributes of
Nonsterile Drug Products
Establishes criteria or justification for
skip-lot testing or exclusion of test.
