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ASTM E2898-13

(Guide)

Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

SIGNIFICANCE AND USE
4.1 This guide supports the principles of Guide E2500 and extends these principles to validation of analytical methods for PAT applications. The ongoing process of method validation is graphically represented in Fig. 1, which shows the life cycle of the validation of analytical methods for PAT applications. Prerequisites for validation are the identification of the measurement requirements and development of a method to meet those requirements.  
4.2 The method risk assessment also takes into account the stage in the product life cycle at which the measurements are being made and how the resulting data will be used. The integration of these considerations in the risk assessment facilitates the determination of the level of validation necessary to ensure that the method is fit for purpose.  
4.3 Changes may occur during the product life cycle necessitating identification of changes to the measurement requirements and method update and revalidation. Procedures should be established to evaluate the continued suitability of the process analytical method.  
4.4 Additional informative examples can be found in Practices D3764, D6122, E1655, E1790, E2056, and E2617 that address validation of methods and models. Other useful standards include ASME BPE2009, ISO 14971, ISO 15839, and USP Acoustic Emission  .
SCOPE
1.1 This guide provides an overview to the risk-based validation of process analytical methods under a process analytical technology (PAT) paradigm for pharmaceuticals and biopharmaceuticals and as such includes guidance on assessing risk to product quality from inappropriate method validation.  
1.2 This guide builds on existing standards on the topic of validation concentrating on applying such standards to analytical methods for on-line analysis. In particular, it addresses the validation of at-line, on-line, or in-line PAT measurements and covers both API and Drug Product (DP) measurements.  
1.3 The definitions of International Conference on Harmonization (ICH) validation parameters (such as specificity, precision, repeatability, etc.) apply; however, the method of demonstrating the validation parameters may vary from that described in ICH and is discussed.  
1.4 As consistent with the U.S. Food and Drug Administration (FDA) process validation guidance, this document also briefly covers ongoing assurance that the method remains in a validated state during routine use.  
1.5 Equipment and instrument qualification are out of the scope of this guide but will be referenced as inputs to validation of analytical methods for PAT applications.  
1.6 The validation of multivariate prediction models is out of scope but will be referenced as inputs to validation of analytical methods for PAT applications.  
1.7 Microbiological methods are out of scope.  
1.8 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
31-Oct-2013
ICS
11.120.99 - Other standards related to pharmaceutics
Technical Committee
E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
Drafting Committee
E55.01 - Process Understanding and PAT System Management, Implementation and Practice
Current Stage
Ref Project

Relations

Replaced By
ASTM E2898-14 - Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
Effective Date
01-Jun-2014
Referred By
ASTM E2968-23 - Standard Guide for Application of Continuous Manufacturing (CM) in the Pharmaceutical Industry
Effective Date
01-Nov-2013
Referred By
ASTM E3326-22 - Standard Guide for Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry
Effective Date
01-Nov-2013
Referred By
ASTM E2629-20 - Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
Effective Date
01-Nov-2013

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ASTM E2898-13 - Standard Guide for Risk-Based Validation of Analytical Methods for PAT ApplicationsASTM E2898-13 - Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
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ASTM E2898-13 - Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E2898 − 13
StandardGuide for
Risk-Based Validation of Analytical Methods for PAT
1
Applications
This standard is issued under the fixed designation E2898; 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 2. Referenced Documents
2
1.1 This guide provides an overview to the risk-based 2.1 ASTM Standards:
validation of process analytical methods under a process
D3764 Practice forValidation of the Performance of Process
analytical technology (PAT) paradigm for pharmaceuticals and
Stream Analyzer Systems
biopharmaceuticalsandassuchincludesguidanceonassessing D6122 Practice for Validation of the Performance of Multi-
risk to product quality from inappropriate method validation.
variate Online,At-Line, and Laboratory Infrared Spectro-
photometer Based Analyzer Systems
1.2 This guide builds on existing standards on the topic of
E1655 Practices for Infrared Multivariate Quantitative
validation concentrating on applying such standards to analyti-
Analysis
cal methods for on-line analysis. In particular, it addresses the
E1790 Practice for Near Infrared Qualitative Analysis
validation of at-line, on-line, or in-line PAT measurements and
E2056 Practice for Qualifying Spectrometers and Spectro-
covers both API and Drug Product (DP) measurements.
photometers for Use in Multivariate Analyses, Calibrated
1.3 The definitions of International Conference on Harmo-
Using Surrogate Mixtures
nization (ICH) validation parameters (such as specificity,
E2476 Guide for Risk Assessment and Risk Control as it
precision, repeatability, etc.) apply; however, the method of
Impacts the Design, Development, and Operation of PAT
demonstrating the validation parameters may vary from that
Processes for Pharmaceutical Manufacture
described in ICH and is discussed.
E2500 Guide for Specification, Design, and Verification of
Pharmaceutical and Biopharmaceutical Manufacturing
1.4 As consistent with the U.S. Food and DrugAdministra-
Systems and Equipment
tion (FDA) process validation guidance, this document also
E2617 Practice for Validation of Empirically Derived Mul-
briefly covers ongoing assurance that the method remains in a
tivariate Calibrations
validated state during routine use.
E2629 Guide for Verification of ProcessAnalytical Technol-
1.5 Equipment and instrument qualification are out of the
ogy (PAT) Enabled Control Systems
scope of this guide but will be referenced as inputs to
3
2.2 ICH Standards:
validation of analytical methods for PAT applications.
Q2(R1) Guidance on Validation of Analytical Procedures:
1.6 The validation of multivariate prediction models is out
Text and Methodology
of scope but will be referenced as inputs to validation of
Q7 Good Manufacturing Practice Guide for Active Pharma-
analytical methods for PAT applications.
ceutical Ingredients
Q9 Quality Risk
1.7 Microbiological methods are out of scope.
ICH Quality Implementation Working Group Points to
1.8 This standard does not purport to address all of the
Consider (R2) ICH-Endorsed Guide for ICH Q8/Q9/Q10
safety concerns, if any, associated with its use. It is the
Implementation dated 6 December 2011
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
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
1
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture the ASTM website.
3
of Pharmaceutical Products and is the direct responsibility of Subcommittee E55.01 Available from International Conference on Harmonisation of Technical
on PAT System Management, Implementation and Practice. Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH
Current edition approved Nov. 1, 2013. Published December 2013. DOI: Secretariat, c/o IFPMA, 15 ch. Louis-Dunant, P.O. Box 195, 1211 Geneva 20,
10.1520/E2898-13. Switzerland, http://www.ich.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2898 − 13
2.3 Other Standards: 3.1.10.1 Discussion—Qualification is part of validation, but
4
ASME BPE2009 BioProcessing Equipment Standard the individual qualification steps alone do not constitute
FDA Guidance for Industry Process Validation: General process validation. FDA/ICH Q7A
5
Principles and Practices
3.1.11 q
...

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4.1 The test methods outlined in this standard allow for suppliers and end users of SUSs in (bio)pharmaceutical manufacturing processes to detect a leak and/or confirm the barrier properties of empty, clean, and dry SUSs. Performing integrity testing can be a significant contribution to the overall integrity assurance of SUSs.  
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1.1 The test methods described in this standard are applicable for single-use manufacturing equipment, further called Single-use Systems (SUSs), used for (bio)pharmaceutical products.  
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1.5.1 Pressure-based test methods.  
1.5.2 Tracer gas-based test methods.  
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3.1 This practice deals with recommended best practices for freeze dryer instrumentation, particularly which is used for monitoring the status of the product during freeze drying and perhaps for equipment capability testing. Temperature and pressure are both critical variables affecting heat transfer, mass transfer, process efficiency, and product quality. For this reason, particular emphasis is placed on product temperature and pressure measurement within the freeze dryer. The methods discussed in this guide are limited to techniques that are equally applicable at both laboratory and production scale.  
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1.1 Recommended best practices in monitoring of product status during pharmaceutical freeze drying are presented focusing on methods that apply to both laboratory and production scale.  
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Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

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SIGNIFICANCE AND USE
4.1 This guide supports the principles of Guide E2500 and extends these principles to validation of analytical methods for PAT applications. The ongoing process of method validation is graphically represented in Fig. 1, which shows the life cycle of the validation of analytical methods for PAT applications. Prerequisites for validation are the identification of the measurement requirements and development of a method to meet those requirements.  
FIG. 1 Life Cycle for the Validation of Analytical Method for PAT Applications  
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1.1 This practice describes the requirements for development, qualification, and routine application of a procedure for the effective liquid extraction of particulate matter from the surfaces of single-use components and assemblies designed for use in biopharmaceutical manufacturing processes. The extraction generates a suspension of particulate matter in liquid which makes the particulate matter readily available for analytical characterization.  
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1.1 This guide is intended as a complement to Guide E2500.  
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1.3 Definitions that are identical to those published by other ASTM committees or other standards organizations are identified with the committee number (for example, D20) or with the abbreviation of the name of the organization (for example, IUPAC, International Union of Pure and Applied Chemistry).  
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SCOPE
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1.2 This standard applies to controlling the environment surrounding packaged cannabis/hemp flower in transit, either within the package itself or in the environment surrounding the package, or both.  
1.3 This standard is to be followed by licensed operators in the cannabis/hemp space who move the packaged crop(s) through the distribution supply chain to another licensed operator or to the end user.  
1.4 Purveyors of cannabis/hemp flower include, but are not necessarily limited to: the packager, transportation companies, warehousing operations, and retail operations.  
1.5 Security of the packaged cannabis/hemp flower while in transit is not within the scope of this standard.  
1.6 This standard is intended to remain valid until ownership of the packaged cannabis/hemp flower is transferred to another licensed operator or to the final consumer.  
1.7 Authorities having jurisdiction may have additional or alternate requirements which shall take precedence or supersede this standard.  
1.8 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.  
1.9 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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ASTM
ASTM D8500-23(Guide)
Standard Guide for Meeting the Specifications of ASTM D8423

SIGNIFICANCE AND USE
4.1 Standards and practices for assuring safety, quality, and weight stabilization during key steps of the cannabis/hemp flowers’ sojourn are in order.  
4.2 This standard is intended to assure safety, quality, and weight stabilization of packaged cannabis/hemp flower during storage.  
4.3 This standard is intended to be used by purveyors who store the packaged cured flower between packaging and subsequent transfer to other licensed operators or to the end user.  
4.4 This standard is intended to be used by samplers and testing laboratories storing samples prior to laboratory analyses to assure that samples analyzed represent as accurately as possible, the material that was gathered to provide the sample for analysis.
SCOPE
1.1 Specification D8423 covers the environmental conditions, such as temperature, humidity, and lighting under which the cured dry cannabis/hemp flowers packaged in fresh format and intended for human use can be maintained in storage to assure the safety, quality, and weight stabilization of the packaged flower. This guide suggests means by which the purveyor of storage of cannabis/hemp can meet those specifications.  
1.1.1 This standard does not apply to frozen cannabis/hemp.  
1.1.2 This standard does not apply to cannabis/hemp intended for extraction.  
1.2 The standard applies to controlling the environment surrounding packaged cannabis/hemp flower during storage, either within the package itself or in the environment surrounding the package, or both.  
1.3 This standard is to be followed by licensed operators in the cannabis/hemp space who move the packaged crop(s) through the distribution supply chain to another licensed operator or to the end user.  
1.4 Purveyors of cannabis/hemp flower include, but are not necessarily limited to: the packager, transportation companies, warehousing operations, and retail operations.  
1.5 Security of the packaged cannabis/hemp flower while in storage is not within the scope of this standard.  
1.6 This standard is intended to remain valid until ownership of the packaged cannabis/hemp flower is transferred to another licensed operator or to the final consumer.  
1.7 Authorities having jurisdiction may have additional or alternate requirements which shall take precedence or supersede this standard.  
1.8 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.  
1.9 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.

  • Guide
    4 pages
    English language
    sale 15% off