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ASTM E 2537 : 2016

Current
Current

The latest, up-to-date edition.

Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

08-10-2023

This guide describes Continuous Process Verification as an alternate approach to process validation where manufacturing process (or supporting utility system) performance is continuously monitored, evaluated, and adjusted (as necessary).

1.1This guide describes Continuous Process Verification as an alternate approach to process validation where manufacturing process (or supporting utility system) performance is continuously monitored, evaluated, and adjusted (as necessary). It is a science-based approach to verify that a process is capable and will consistently produce product meeting its predetermined critical quality attributes. Continuous Process Verification (ICH Q8) is similarly described as Continuous Quality Verification.

1.2Pharmaceutical and biopharmaceutical product manufacturing companies are required to provide assurance that the processes used to manufacture regulated products result in products with the specified critical quality attributes of strength identity and purity associated with the product safety and efficacy. Process validation is a way in which companies provide that assurance.

1.3With the knowledge obtained during the product lifecycle, a framework for continuous quality improvements will be established where the following may be possible: (1) risk identified, (2) risk mitigated, (3) process variability reduced, (4) process capability enhanced, (5) process design space defined or enhanced, and ultimately (6) product quality improved. This can enable a number of benefits that address both compliance and operational goals (for example, real time release, continuous process improvement).

1.4The principles in this guide may be applied to drug product or active pharmaceutical ingredient/drug substance pharmaceutical and biopharmaceutical batch or continuous manufacturing processes or supporting utility systems (for example, TOC for purified water and water for injection systems, and so forth).

1.5The principles in this guide may be applied during the development and manufacturing of a new process or product or for the improvement or redesign, or both, of an existing process.

1.6Continuous process verification may be applied to manufacturing processes that use monitoring systems that provide frequent and objective measurement of process data in real time. These processes may or may not employ in-, on-, or at-line analyzers/controllers that monitor, measure, analyze, and control the process performance. The associated processes may or may not have a design space.

1.7This guide may be used independently or in conjunction with other proposed E55 standards to be published by ASTM International.

Committee
E 55
DocumentType
Guide
Pages
5
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

ASTM E 2968 : 2014 Standard Guide for Application of Continuous Processing in the Pharmaceutical Industry
ASTM E 2629 : 2019 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
ASTM E 2500 : 2013 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM E 2656 : 2016 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute
ASTM E 3326 : 2022 Standard Guide for Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry
ASTM E 2968 : 2023 Standard Guide for Application of Continuous Manufacturing (CM) in the Pharmaceutical Industry
ASTM E 2629 : 2020 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
ASTM E 2500 : 2020 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

ASTM E 2363 : 2005 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2363 : 2005 : REV B Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2363 : 2023 Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
ASTM E 2363 : 2004 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2363 : 2006 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2363 : 2004 : REV A Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2363 : 2005 : REV A Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2363 : 2006 : REV A Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2363 : 2014 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

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