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ASTM E 2629 : 2011

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
Available format(s)

Hardcopy , PDF

Superseded date

04-07-2019

Language(s)

English

Published date

15-04-2011

CONTAINED IN VOL. 14.02, 2017 Specifies the verification of process analytical technology (PAT) enabled control systems using a science- and risk-based approach.

1.1 This guide describes the verification of process analytical technology (PAT) enabled control systems using a science- and risk-based approach. It establishes principles for determining the scope and extent of verification activities necessary to ensure that the PAT-enabled control system is fit for purpose, properly implemented, and functions as expected.

1.2 In this guide, a PAT-enabled control system is considered to be the system that adjusts the manufacturing process using timely measurements (that is, during processing) of attributes of raw and in-process materials to determine responses that assure the process remains within specified boundaries and minimizes variability in the output material. The overall aim of the PAT-enabled control system is to ensure product quality. The PAT-enabled control system of a manufacturing process provides the capability to determine the current status of the process and drive the process to ensure the output material has the desired quality characteristics. The control system should be able to respond to process variations in a timely manner, providing corrections that ensure that the process follows the desired process trajectory to reach the desired outcome. PAT-enabled control systems may use process models based on first principles understanding or empirical models derived from experimental investigations or both. In addition to automated controls, a PAT-enabled control system may include components where there is manual intervention.

1.3 Principles described in this guide may be applied regardless of the complexity or scale of the PAT-enabled control system or whether applied to batch or continuous processing, or both.

1.4 The principles described in this guide are applicable to a PAT-enabled control system and also to its component subsystems. This guide does not cover the requirements for continuous quality verification of the overall process, which are covered in Guide E2537.

1.5 For information on science- and risk-based approaches in the pharmaceutical industry, reference should be made to ICH Q8(R2), ICH Q9, and ICH Q10. For guidance on PAT systems in the pharmaceutical industry, reference should be made to FDA Guidance for IndustryPAT and FDA Guidance for IndustryProcess Validation.

1.6 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.

Committee
E 55
DocumentType
Guide
Pages
6
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

ASTM E 2500 : 2013 : REDLINE Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM E 2986 : 2015 Standard Guide for Evaluation of Environmental Aspects of Sustainability of Manufacturing Processes
ASTM E 2898 : 2014 : REDLINE Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
ASTM E 2363 : 2014 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2474 : 2014 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020)
ASTM E 2986 : 2018 Standard Guide for Evaluation of Environmental Aspects of Sustainability of Manufacturing Processes
ASTM E 2500 : 2013 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM E 2898 : 2014 Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
ASTM E 2474 : 2014 : REDLINE Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
ASTM E 2363 : 2014 : REDLINE Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

ASTM E 122 : 2017 : REDLINE Standard Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process
ASTM E 2363 : 2014 : REDLINE Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2476 : 2016 : REDLINE Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
ASTM E 2500 : 2013 : REDLINE Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM E 2537 : 2016 : REDLINE Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing

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