ASTM E2810-23
(Practice)Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units
Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units
SIGNIFICANCE AND USE
4.1 The methodology was originally developed (1-4)6 for use in drug content uniformity and dissolution but has general application to any multistage test with multiple acceptance criteria. Practice E2709 summarizes the statistical aspects of this methodology. This practice applies the general methodology of Practice E2709 specifically to the UDU test.
4.1.1 While other methods can be used to estimate the probability of passing the UDU test, they are outside the scope of this practice.
4.2 The UDU test procedure describes a two-stage sampling test, where at each stage one can pass or continue testing, and the decision to fail is deferred until the second stage. At each stage there are acceptance criteria on the test results as outlined in Table 1.
4.3 The UDU test is a market standard. The USP General Notices include the following statement about compendial standards. “The similarity to statistical procedures may seem to suggest an intent to make inference to some larger group of units, but in all cases, statements about whether the compendial standard is met apply only to the units tested.” Therefore, the UDU procedure is not intended for inspecting uniformity of finished product for lot/batch release or as a lot inspection procedure.
4.3.1 The UDU test defines a product requirement to be met at release and throughout the shelf-life of the product.
4.3.2 Passing the UDU test once does not provide statistical assurance that a batch of drug product meets specified statistical quality control criteria.
4.4 This practice provides a practical specification that may be applied when uniformity of dosage units is required. An acceptance region for the mean and standard deviation of a set of test results from the lot is defined such that, at a prescribed confidence level, the probability that a future sample from the lot will pass the UDU test is greater than or equal to a prespecified lower probability bound. Having test results fall in the acceptance r...
SCOPE
1.1 This practice provides a general procedure for evaluating the capability to comply with the Uniformity of Dosage Units (UDU) test. This test is given in General Chapter Uniformity of Dosage Units of the USP, in 2.9.40 Uniformity of Dosage Units of the Ph. Eur., and in 6.02 Uniformity of Dosage Units of the JP, and these versions are virtually interchangeable. For this multiple-stage test, the procedure computes a lower bound on the probability of passing the UDU test, based on statistical estimates made at a prescribed confidence level from a sample of dosage units.
1.2 This methodology can be used to generate an acceptance limit table, which defines a set of sample means and standard deviations that assures passing the UDU test for a prescribed lower probability bound, confidence level, and sample size.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E2810 − 23
Standard Practice for
Demonstrating Capability to Comply with the Test for
1
Uniformity of Dosage Units
This standard is issued under the fixed designation E2810; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope E2709 Practice for Demonstrating Capability to Comply
with an Acceptance Procedure
1.1 This practice provides a general procedure for evaluat-
ing the capability to comply with the Uniformity of Dosage 2.2 Other Documents:
3
Units (UDU) test. This test is given in General Chapter <905> JP Japanese Pharmacopoeia
4
Uniformity of Dosage Units of the USP, in 2.9.40 Uniformity Ph. Eur. European Pharmacopoeia
5
of Dosage Units of the Ph. Eur., and in 6.02 Uniformity of USP United States Pharmacopeia
Dosage Units of the JP, and these versions are virtually
interchangeable. For this multiple-stage test, the procedure
3. Terminology
computes a lower bound on the probability of passing the UDU
3.1 Definitions—See Terminology E2363 for a more exten-
test, based on statistical estimates made at a prescribed
sive listing of terms in ASTM Committee E55 standards.
confidence level from a sample of dosage units.
3.2 Definitions of Terms Specific to This Standard:
1.2 This methodology can be used to generate an acceptance
3.2.1 acceptable parameter region, n—the set of values of
limit table, which defines a set of sample means and standard
parameters characterizing the distribution of test results for
deviations that assures passing the UDU test for a prescribed
which the probability of passing the lot acceptance procedure
lower probability bound, confidence level, and sample size.
is greater than a prescribed lower bound.
1.3 This standard does not purport to address all of the
3.2.2 acceptance limit, n—the boundary of the acceptance
safety concerns, if any, associated with its use. It is the
region, for example, the maximum sample standard deviation
responsibility of the user of this standard to establish appro-
for a given sample mean or minimum and maximum sample
priate safety, health, and environmental practices and deter-
mean for given standard deviations.
mine the applicability of regulatory limitations prior to use.
3.2.2.1 Discussion—The coefficient of variation (relative
1.4 This international standard was developed in accor-
standard deviation) may be substituted for the standard devia-
dance with internationally recognized principles on standard-
tion where applicable.
ization established in the Decision on Principles for the
3.2.3 acceptance region, n—the set of values of parameter
Development of International Standards, Guides and Recom-
estimates (that is, sample mean and standard deviation) where
mendations issued by the World Trade Organization Technical
confidence limits attain a prescribed lower bound on the
Barriers to Trade (TBT) Committee.
probability of passing a lot acceptance procedure.
2. Referenced Documents
3.2.4 confidence level, C, n—the prescribed overall level for
2
2.1 ASTM Standards: calculating the uncertainty region of the parameters from the
E2363 Terminology Relating to Manufacturing of Pharma-
sample estimates.
ceutical and Biopharmaceutical Products in the Pharma- 3.2.4.1 Discussion—The preset confidence level is stated as
ceutical and Biopharmaceutical Industry
a percentage, for example, 100 (1 – α) = 95 %, where α is a
risk that is allocated to the two parameters being estimated.
1
This practice is under the jurisdiction of ASTM Committee E55 on Manufac-
ture of Pharmaceutical and Biopharmaceutical Products and is the direct responsi-
3
bility of Subcommittee E55.14 on Measurement Systems and Analysis. Available from the Pharmaceuticals and Medical Devices Agency (PMDA),
Current edition approved Dec. 1, 2023. Published December 2023. Originally Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013,
approved in 2011. Last previous edition approved in 2019 as E2810 – 19. DOI: Japan, https://www.pmda.go.jp.
4
10.1520/E2810-23. Available from the European Directorate for the Quality of Medicines and
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Health Care (EDQM), Council of Europe, 7 allée Kastner, CS 30026, F-67081
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Strasbourg, France, http://www.edqm.eu.
5
Standards volume information, refer to the standard’s Document Summary page on Available from U.S. Pharmacopeial C
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E2810 − 19 E2810 − 23
Standard Practice for
Demonstrating Capability to Comply with the Test for
1
Uniformity of Dosage Units
This standard is issued under the fixed designation E2810; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This practice provides a general procedure for evaluating the capability to comply with the Uniformity of Dosage Units (UDU)
test. This test is given in General Chapter <905> Uniformity of Dosage Units of the USP, in 2.9.40 Uniformity of Dosage Units
of the Ph. Eur., and in 6.02 Uniformity of Dosage Units of the JP, and these versions are virtually interchangeable. For this
multiple-stage test, the procedure computes a lower bound on the probability of passing the UDU test, based on statistical estimates
made at a prescribed confidence level from a sample of dosage units.
1.2 This methodology can be used to generate an acceptance limit table, which defines a set of sample means and standard
deviations that assures passing the UDU test for a prescribed lower probability bound, confidence level, and sample size.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
E2363 Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and
Biopharmaceutical Industry
1
This practice is under the jurisdiction of ASTM Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products and is the direct responsibility of
Subcommittee E55.14 on Measurement Systems and Analysis.
Current edition approved April 1, 2019Dec. 1, 2023. Published August 2019December 2023. Originally approved in 2011. Last previous edition approved in 20172019
as E2810 – 11 (2017). DOI: 10.1520/E2810-19.19. DOI: 10.1520/E2810-23.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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E2810 − 23
E2709 Practice for Demonstrating Capability to Comply with an Acceptance Procedure
2.2 Other Documents:
3
JP Japanese Pharmacopoeia
4
Ph. Eur. European Pharmacopoeia
5
USP United States Pharmacopeia
3. Terminology
3.1 Definitions—See Terminology E2363 for a more extensive listing of terms in ASTM Committee E55 standards.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 acceptable parameter region, n—the set of values of parameters characterizing the distribution of test results for which the
probability of passing the lot acceptance procedure is greater than a prescribed lower bound.
3.2.2 acceptance limit, n—the boundary of the acceptance region, for example, the maximum sample standard deviation for a
given sample mean or minimum and maximum sample mean for given standard deviations.
3.2.2.1 Discussion—
The coefficient of variation (relative standard deviation) may be substituted for the standard deviation where applicable.
3.2.3 acceptance region, n—the set of values of parameter estimates (that is, sample mean and standard deviation) where
confidence limits attain a prescribed lower bound on the probability of passing a lot acceptance procedure.
3.2.4 confidence level, C, n—the prescribed overall level for calculating the uncertainty region of the parameters from the sample
estimates.
3.2.4.1 Discussion—
The preset confidence level is stated as a percentage, for example, 100 (1 – α) = 95 %, where α is a risk that is allocated to the two
parameters being estimated.
3.2.5 lower probability boun
...
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