ASTM E3106-17
(Guide)Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
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 another existing guide (1)2).
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.
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Designation: E3106 − 17
Standard Guide for
Science-Based and Risk-Based Cleaning Process
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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. Scope Impacts the Design, Development, and Operation of PAT
Processes for Pharmaceutical Manufacture
1.1 This guide applies the life-cycle approach to cleaning
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2.2 ICH Standards:
process validation, which includes the development,
Q8 Pharmaceutical Development
qualification, and verification of cleaning processes. It is
Q9 Quality Risk Management
applicabletopharmaceuticals(includingactivepharmaceutical
Q10 Pharmaceutical Quality System
ingredients (APIs); dosage forms; and over-the-counter,
Q11 Development and Manufacture of Drug Substances
veterinary, biologics, and clinical supplies) and is also appli-
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cable to other health, cosmetics, and consumer products.
2.3 ISO Standards:
ISO 9000 Quality Management Systems—Fundamentals
1.2 This guide is focused only on the cleaning of equipment
and Vocabulary
product contact surfaces and does not cover disinfection or
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non-product contact surfaces (which are covered under another 2.4 Federal Standards:
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existing guide (1) ).
21 CFR 211.67 Equipment Cleaning and Maintenance
1.3 The values stated in SI units are to be regarded as
3. Terminology
standard. No other units of measurement are included in this
standard. 3.1 Definitions:
3.1.1 acceptable daily exposure, ADE, n—represents a dose
1.4 This standard does not purport to address all of the
that is unlikely to cause an adverse effect if an individual is
safety concerns, if any, associated with its use. It is the
exposed, by any route, at or below this dose every day for a
responsibility of the user of this standard to establish appro-
lifetime.
priate safety, health, and environmental practices and deter-
3.1.1.1 Discussion—This is the term used in the ISPE
mine the applicability of regulatory limitations prior to use.
Risk-MaPP Guide (1) and is equivalent to the acceptable daily
1.5 This international standard was developed in accor-
intake(ADI)butisassociatedwithanyrouteofadministration.
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the 3.1.2 acceptable daily intake, ADI, n—measure of the
Development of International Standards, Guides and Recom- amount of a specific substance (originally applied for a food
mendations issued by the World Trade Organization Technical additive, later also for a residue of a veterinary drug or
Barriers to Trade (TBT) Committee. pesticide) in food or drinking water that can be ingested
(orally) on a daily basis over a lifetime without an appreciable
2. Referenced Documents
health risk. Ref (2)
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3.1.2.1 Discussion—This term is more commonly associ-
2.1 ASTM Standards:
ated with food and the oral route of administration.
E1325 Terminology Relating to Design of Experiments
E2476 Guide for Risk Assessment and Risk Control as it
3.1.3 clean-in-place, CIP, n—method of cleaning without
dismantling equipment.
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This guide is under the jurisdiction of ASTM Committee E55 on Manufacture
ofPharmaceuticalandBiopharmaceuticalProductsandisthedirectresponsibilityof
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Subcommittee E55.03 on General Pharmaceutical Standards. Available from International Conference on Harmonisation of Technical
Current edition approved Dec. 1, 2017. Published May 2018. DOI: 10.1520/ Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH
E3106-17. Secretariat, 9, chemin des Mines, P.O. Box 195, 1211 Geneva 20, Switzerland,
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The boldface numbers in parentheses refer to a list of references at the end of http://www.ich.org.
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this standard. Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or 4th Floor, New York, NY 10036, http://www.ansi.org.
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contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Available from U.S. Government Printing Office, Superintendent of
Standards volume information, refer to the standard’s Document Summary page on Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://
the ASTM website. www.access.gpo.gov.
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E3106 − 17
3.1.4 cleanability, n—relative difficulty for cleaning a piece 3.1.14 coupon, n—representative surface that is typically a
of equipment or product. rectang
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