ASTM E2476-16
(Guide)Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
SIGNIFICANCE AND USE
4.1 This guide is intended to provide guidance regarding the use of risk management in the development, day-to-day running, and continuous improvement of pharmaceutical processes incorporating Process Analytical Technology (PAT). Since PAT is defined as being “risk-based” (see FDA Guidance for Industry), it is important that a consistent approach to the use of risk methodologies is adopted, to ensure rapid transfer of process understanding within the development and manufacturing teams, and to the regulators where that is appropriate.
4.2 This guidance only covers those aspects of risk assessment related to “risk to product quality.” Other aspects (such as “risk to patient”) should be covered in the conventional manner.
SCOPE
1.1 This document provides guidance on the assessment of risks to product quality within and related to PAT processes in the pharmaceutical industry. It addresses those risks to product quality arising from, associated with, identified by, or modified by the implementation of PAT in pharmaceutical development and manufacturing for primary, secondary, and biotech sectors of the industry. It does not replace those assessments of risk currently undertaken by pharmaceutical companies, but is, rather, an additional component focused specifically upon the evaluation and design of PAT processes. See Practice E2474, Guide E2500, and ICH Q8.
1.2 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. Note that safety in this context refers to operational and operator safety, not to patient safety.
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Designation: E2476 − 16
Standard Guide for
Risk Assessment and Risk Control as it Impacts the Design,
Development, and Operation of PAT Processes for
1
Pharmaceutical Manufacture
This standard is issued under the fixed designation E2476; 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.
INTRODUCTION
This document provides guidance on the implementation of risk assessment and risk control for
Process Analytical Technology (PAT) processes within the pharmaceutical industry. Wherever
possible, other appropriate standards on risk assessment/management have been referenced and
acknowledged. Where practical, further details of methods and additional references have been
provided for information within the appendixes.
The application of risk assessment and risk control is pivotal to the creation of PAT systems, which
are described as “science-based” and “risk-based.” Such application starts at an early stage in the
development of the process and continues throughout development and production. In the production
phase, it is a crucial component of applying continuous improvement to the process.
RELATIONSHIP TO ICH Q9
The ICH Q9 Guideline for Quality Risk Management is intended for general application within the
pharmaceutical industry. ICH Q9 describes the requirements for pharmaceutical quality risk
management and considers the risk as “risk to the patient.”
This document provides specific guidance on the risk assessment and risk control phases identified
in ICH Q9 in a limited set of conditions. It is applicable where the manufacturing method is compliant
with Process Analytical Technology (PAT) principles, and where the primary considerations are
productqualityandreductionofprocessandproductvariability.Theonlycomponentofrisktopatient
considered here is risk to product quality. Other components fall outside the scope of the document.
In addition, other areas identified in ICH Q9, such as general risk management and risk
communication, are not considered here.
This document provides guidance which applies to the design, development, and operation of PAT
systems. It should be considered as a specific extension, supporting the ICH Q9 guidance for these
processes.
1. Scope the pharmaceutical industry. It addresses those risks to product
quality arising from, associated with, identified by, or modified
1.1 This document provides guidance on the assessment of
by the implementation of PAT in pharmaceutical development
risks to product quality within and related to PAT processes in
and manufacturing for primary, secondary, and biotech sectors
of the industry. It does not replace those assessments of risk
1
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture
currently undertaken by pharmaceutical companies, but is,
ofPharmaceuticalandBiopharmaceuticalProductsandisthedirectresponsibilityof
Subcommittee E55.01 on Process Understanding and PAT System Management, rather, an additional component focused specifically upon the
Implementation and Practice.
evaluation and design of PAT processes. See Practice E2474,
Current edition approved Nov. 1, 2016. Published November 2016. Originally
Guide E2500, and ICH Q8.
approved in 2009. Last previous edition approved in 2009 as E2476 – 09. DOI:
10.1520/E2476-16.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E2476 − 16
1.2 This standard does not purport to address all of the useofriskmethodologiesisadopted,toensurerapidtransferof
safety concerns, if any, associated with its use. It is the process understanding within the development and manufac-
responsibility of the user of this standard to establish appro- turing teams, and to the regulators where that is appropriate.
priate safety and health practices and determine the applica-
4.2 This guidance only covers those aspects of risk assess-
bility of regulatory limitations prior to use. Note that safety in
mentrelatedto“risktoproductquality.”Otheraspects(suchas
this context refers to operational and operator safety, not to
“risk to patient”) should be covered in the conventional
patient safety.
manner.
2. Referenced Documents
5. Principles of Risk Assessment and Risk Control
2
2.1 ASTM Standards:
5.1 Background—Risk management has been widely used
E2474 Practice for Pharmaceutical Process Design Utilizing
in manufacturing and service industries for many years. In
Process Analytical Technology
some industries, risk management has become formalized into
E2500 Guide for Specification, Design,
...
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: E2476 − 09 E2476 − 16
Standard Guide for
Risk Assessment and Risk Control as it Impacts the Design,
Development, and Operation of PAT Processes for
1
Pharmaceutical Manufacture
This standard is issued under the fixed designation E2476; 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.
INTRODUCTION
This document provides guidance on the implementation of risk assessment and risk control for
Process Analytical Technology (PAT) processes within the pharmaceutical industry. Wherever
possible, other appropriate standards on risk assessment/management have been referenced and
acknowledged. Where practical, further details of methods and additional references have been
provided for information within the appendixes.
The application of risk assessment and risk control is pivotal to the creation of PAT systems, which
are described as “science-based” and “risk-based.” Such application starts at an early stage in the
development of the process and continues throughout development and production. In the production
phase, it is a crucial component of applying continuous improvement to the process.
RELATIONSHIP TO ICH Q9
The ICH Q9 Guideline for Quality Risk Management is intended for general application within the
pharmaceutical industry. ICH Q9 describes the requirements for pharmaceutical quality risk
management and considers the risk as “risk to the patient.”
This document provides specific guidance on the risk assessment and risk control phases identified
in ICH Q9 in a limited set of conditions. It is applicable where the manufacturing method is compliant
with Process Analytical Technology (PAT) principles, and where the primary considerations are
product quality and reduction of process and product variability. The only component of risk to patient
considered here is risk to product quality. Other components fall outside the scope of the document.
In addition, other areas identified in ICH Q9, such as general risk management and risk
communication, are not considered here.
This document provides guidance which applies to the design, development, and operation of PAT
systems. It should be considered as a specific extension, supporting the ICH Q9 guidance for these
processes.
1. Scope
1.1 This document provides guidance on the assessment of risks to product quality within and related to PAT processes in the
pharmaceutical industry. It addresses those risks to product quality arising from, associated with, identified by, or modified by the
implementation of PAT in pharmaceutical development and manufacturing for primary, secondary, and biotech sectors of the
industry. It does not replace those assessments of risk currently undertaken by pharmaceutical companies, but is, rather, an
additional component focused specifically upon the evaluation and design of PAT processes. See Practice E2474, Guide E2500,
and ICH Q8.
1.2 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. Note that safety in this context refers to operational and operator safety, not to patient safety.
1
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products and is the direct responsibility of
Subcommittee E55.01 on Process Understanding and PAT System Management, Implementation and Practice.
Current edition approved May 15, 2009Nov. 1, 2016. Published July 2009November 2016. DOI: 10.1520/E2476-09.Originally approved in 2009. Last previous edition
approved in 2009 as E2476 – 09. DOI: 10.1520/E2476-16.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E2476 − 16
2. Referenced Documents
2
2.1 ASTM Standards:
E2474 Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
E2500 Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and
Equipment
E2363 Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
2.2 Other Standards:
FDA Guidance for Ind
...
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