ASTM E3106-18e1

Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation

SIGNIFICANCE AND USE
4.1 Application of the approach described within this guide applies risk-based concepts and principles introduced in ICH Q9. As stated in ICH Q9, the level of effort, formality and documentation for cleaning should also be commensurate with the level of risk.  
4.2 Application of the approach described within this guide applies many of the science-based, risk-based, and statistical concepts and principles introduced in the FDA’s Guidance for Industry Process Validation: General Principles and Practices   (3).  
4.3 This guide supports, and is consistent with, elements from ICH Q8, ICH Q9, ICH Q10, and ICH Q11.  
4.4 Key Concepts—This guide applies the following key concepts: (1) quality risk management, (2) science-based approach, (3) statistics-based approach, (4) process understanding, and (5) continued improvement as described in the ICH Q series.
SCOPE
1.1 This guide applies the life-cycle approach to cleaning process validation, which includes the development, qualification, and verification of cleaning processes. It is applicable to pharmaceuticals (including active pharmaceutical ingredients (APIs); dosage forms; and over-the-counter, veterinary, biologics, and clinical supplies) and is also applicable to other health, cosmetics, and consumer products.  
1.2 This guide is focused only on the cleaning of equipment product contact surfaces and does not cover disinfection or non-product contact surfaces (which are covered under other existing guides: Ref (1),2 USP , Guide E2614, and ISO 14698).  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 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.  
1.5 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.

General Information

• Status: Historical
• Publication Date: 31-Aug-2018
• ICS: 13.020.60 - Product life-cycles
• Technical Committee: E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
• Drafting Committee: E55.03 - General Pharmaceutical Standards

Standards Content (Sample)

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
´1
Designation: E3106 − 18
Standard Guide for
Science-Based and Risk-Based Cleaning Process
1
Development and Validation
This standard is issued under the fixed designation E3106; 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
ε NOTE—Corrections were made editorially to 3.1.13 in October 2018.
1. Scope 2. Referenced Documents
3
1.1 This guide applies the life-cycle approach to cleaning 2.1 ASTM Standards:
process validation, which includes the development, E1325 Terminology Relating to Design of Experiments
qualification, and verification of cleaning processes. It is E2476 Guide for Risk Assessment and Risk Control as it
applicabletopharmaceuticals(includingactivepharmaceutical Impacts the Design, Development, and Operation of PAT
ingredients (APIs); dosage forms; and over-the-counter, Processes for Pharmaceutical Manufacture
veterinary, biologics, and clinical supplies) and is also appli- E2614 Guide for Evaluation of Cleanroom Disinfectants
4
cable to other health, cosmetics, and consumer products.
2.2 ICH Standards:
Q8 Pharmaceutical Development
1.2 This guide is focused only on the cleaning of equipment
Q9 Quality Risk Management
product contact surfaces and does not cover disinfection or
Q10 Pharmaceutical Quality System
non-product contact surfaces (which are covered under other
2
Q11 Development and Manufacture of Drug Substances
existing guides: Ref (1), USP<1072>, Guide E2614, and ISO
5
14698). 2.3 ISO Standards:
ISO 9000 Quality Management Systems—Fundamentals
1.3 The values stated in SI units are to be regarded as
and Vocabulary
standard. No other units of measurement are included in this
ISO 14698 Guide for Evaluation of Cleanroom
standard.
Disinfectants, Parts 1–3.
1.4 This standard does not purport to address all of the
6
2.4 Federal Standards:
safety concerns, if any, associated with its use. It is the
21 CFR 211.67 Equipment Cleaning and Maintenance
responsibility of the user of this standard to establish appro-
7
2.5 USP Standards:
priate safety, health, and environmental practices and deter-
USP <1072> Disinfectants and Antiseptics
mine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accor-
dance with internationally recognized principles on standard-
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
ization established in the Decision on Principles for the
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Development of International Standards, Guides and Recom-
Standards volume information, refer to the standard’s Document Summary page on
mendations issued by the World Trade Organization Technical
the ASTM website.
4
Barriers to Trade (TBT) Committee. Available from International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH
Secretariat, 9, chemin des Mines, P.O. Box 195, 1211 Geneva 20, Switzerland,
1
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture http://www.ich.org.
5
ofPharmaceuticalandBiopharmaceuticalProductsandisthedirectresponsibilityof Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
Subcommittee E55.03 on General Pharmaceutical Standards. 4th Floor, New York, NY 10036, http://www.ansi.org.
6
Current edition approved Sept. 1, 2018. Published September 2018. Originally Available from U.S. Government Printing Office, Superintendent of
approved in 2017. Last previous edition approved in 2017 as E3106 – 17. DOI: Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://
10.1520/E3106-18E01. www.access.gpo.gov.
2 7
The boldface numbers in parentheses refer to a list of references at the end of Available from U.S. Pharmacopeial Convention (USP), 12601 Twinbrook
this standard. Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
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E3106 − 18
3. Terminology tional considerations such as total cleaning time, holding times
and costs may also be cleaning output attributes.
3.1 Definitions:
3.1.10 cleaningprocess,n—anyprocessdesignedtoremove
3.1.1 acceptable daily exposure, ADE, n—represents a dose
process residues from product contact surfaces of manufactur-
that is unlikely to cause an adverse effect if an individual is
ing equipment to levels that ensure patient safety and product
exposed, by any route, at or below this dose every day for a
quality.
lifetime.
3.1.1.1 D
...

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.
´1
Designation: E3106 − 18 E3106 − 18
Standard Guide for
Science-Based and Risk-Based Cleaning Process
1
Development and Validation
This standard is issued under the fixed designation E3106; 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
ε NOTE—Corrections were made editorially to 3.1.13 in October 2018.
1. Scope
1.1 This guide applies the life-cycle approach to cleaning process validation, which includes the development, qualification, and
verification of cleaning processes. It is applicable to pharmaceuticals (including active pharmaceutical ingredients (APIs); dosage
forms; and over-the-counter, veterinary, biologics, and clinical supplies) and is also applicable to other health, cosmetics, and
consumer products.
1.2 This guide is focused only on the cleaning of equipment product contact surfaces and does not cover disinfection or
2
non-product contact surfaces (which are covered under other existing guides: Ref (1), USP <1072>, Guide E2614, and ISO
14698).
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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.
1.5 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.
2. Referenced Documents
3
2.1 ASTM Standards:
E1325 Terminology Relating to Design of Experiments
E2476 Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes
for Pharmaceutical Manufacture
E2614 Guide for Evaluation of Cleanroom Disinfectants
4
2.2 ICH Standards:
Q8 Pharmaceutical Development
Q9 Quality Risk Management
Q10 Pharmaceutical Quality System
Q11 Development and Manufacture of Drug Substances
5
2.3 ISO Standards:
ISO 9000 Quality Management Systems—Fundamentals and Vocabulary
ISO 14698 Guide for Evaluation of Cleanroom Disinfectants, Parts 1–3.
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 E55.03 on General Pharmaceutical Standards.
Current edition approved Sept. 1, 2018. Published September 2018. Originally approved in 2017. Last previous edition approved in 2017 as E3106 – 17. DOI:
10.1520/E3106-18.10.1520/E3106-18E01.
2
The boldface numbers in parentheses refer to a list of references at the end of this standard.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
4
Available from International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH Secretariat, 9,
chemin des Mines, P.O. Box 195, 1211 Geneva 20, Switzerland, http://www.ich.org.
5
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
´1
E3106 − 18
6
2.4 Federal Standards:
21 CFR 211.67 Equipment Cleaning and Maintenance
7
2.5 USP Standards:
USP <1072> Disinfectants and Antiseptics
6
Available from U.S. Government Printing Office, Superintendent of Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://www.access.gpo.gov.
7
Available from U.S. Pharmacopeial Convention (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
2

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E3106 − 18
3. Terminology
3.1 Definitions:
3.1.1 acceptable daily exposure, ADE, n—represents a dose that is unlikely to cause an adverse effect if an individual
...