ASTM E2898 - 14 - Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

ASTM E2898 - 14

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

Status : Current   Published : January 2014

Format
PDF

Format
HARDCOPY



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.




Standard NumberASTM E2898 - 14
TitleStandard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
StatusCurrent
Publication Date06 January 2014
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors At-line, In-line, In-process measurements, Method development, Method verification, Multivariate modeling, Off-line, On-line, Particle characterization, PAT, Process analytical, Process analytical technology, Process analytics, Process analyzers, Qualification, Risk assessment, Sampling, Validation, Vibrational spectroscopy
ICS11.120.99
PublisherASTM
FormatA4
DeliveryYes
Pages7
File Size0 KB
Price£40.00


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