ASTM E3263-22
(Practice)Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues
Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues
SIGNIFICANCE AND USE
4.1 Application of the approach described within this practice applies the science-based, risk-based, and statistics-based concepts and principles introduced in Guides E3106 and E3219.
4.2 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the inspection of equipment for cleanliness in accordance with 21 CFR 211.67(b)(6) and is in accordance with FDA Process Validation Guidance Life Cycle approach.
4.3 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the visual inspection of equipment for cleanliness in accordance with European Medicines Agency (EMA) Annex 15.
4.4 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the visual inspection of equipment for cleanliness in accordance with the EMA’s Q&A Guidance (Q&A’s #7 and #8) (2).
4.5 Visual Inspection used as described in 4.4 should only be used in situations where there is a suitable safety margin between the VRL and MSSR and robust detectability at the VRL.
4.6 Application of the approach described within this practice applies the risk-based concepts and principles introduced in ICH Q9. As stated in ICH Q9, the level of effort, formality, and documentation for validation (including cleaning validation) should also be commensurate with the level of risk.
4.7 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for releasing manufacturing equipment and manufactured medical devices or cleanliness that is compatible with the U.S. FDA Guidance for Industry, PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance.
4.8 Key Concepts—This practice applies the following key concepts: (1) visual inspection, (2) quality risk management, (3) science-based appr...
SCOPE
1.1 This practice provides statistically valid procedures for determining the visual detection limit of residues and the qualification of inspectors to perform the visual inspection of pharmaceutical manufacturing equipment surfaces and medical devices for residues.
1.2 This practice applies to pharmaceuticals (including active pharmaceutical ingredients (APIs); dosage forms; and over-the-counter, veterinary, biologics, and clinical supplies) and medical devices following all manufacturing and cleaning. This practice is also applicable to other health, cosmetics, and consumer products.
1.3 This practice applies to many types of chemical residues (including APIs, intermediates, cleaning agents, processing aids, machining oils, and so forth) that could remain on manufacturing equipment surfaces or medical devices that have undergone all manufacturing steps including cleaning.
1.4 This practice applies only to equipment or devices that have been justified through a Quality Risk Management program to have an acceptable hazard analysis, have cleaning processes that are repeatable and validated and where Visual Inspection can be relied upon to determine the cleanliness of the equipment at the residue limit justified by the HBEL.
1.5 The values stated in International System of Units (SI) units are to be regarded as standard. No other units of measurement are included in this standard.
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 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 Recommend...
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Designation: E3263 − 22
Standard Practice for
Qualification of Visual Inspection of Pharmaceutical
Manufacturing Equipment and Medical Devices for
1
Residues
This standard is issued under the fixed designation E3263; 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 1.7 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.1 This practice provides statistically valid procedures for
ization established in the Decision on Principles for the
determining the visual detection limit of residues and the
Development of International Standards, Guides and Recom-
qualification of inspectors to perform the visual inspection of
mendations issued by the World Trade Organization Technical
pharmaceutical manufacturing equipment surfaces and medical
Barriers to Trade (TBT) Committee.
devices for residues.
1.2 This practice applies to pharmaceuticals (including ac-
2. Referenced Documents
tive pharmaceutical ingredients (APIs); dosage forms; and 2
2.1 ASTM Standards:
over-the-counter, veterinary, biologics, and clinical supplies)
E2782 Guide for Measurement Systems Analysis (MSA)
and medical devices following all manufacturing and cleaning.
E3106 Guide for Science-Based and Risk-Based Cleaning
This practice is also applicable to other health, cosmetics, and
Process Development and Validation
consumer products.
E3219 Guide for Derivation of Health-Based Exposure Lim-
1.3 This practice applies to many types of chemical residues its (HBELs)
(including APIs, intermediates, cleaning agents, processing G121 Practice for Preparation of Contaminated Test Cou-
aids, machining oils, and so forth) that could remain on pons for the Evaluation of Cleaning Agents
3
manufacturing equipment surfaces or medical devices that 2.2 ICH Guidance:
have undergone all manufacturing steps including cleaning.
Q7 Good Manufacturing Practice Guidance for Active Phar-
maceutical Ingredients
1.4 This practice applies only to equipment or devices that
Q9 Quality Risk Management
have been justified through a Quality Risk Management
Q10 Pharmaceutical Quality System
program to have an acceptable hazard analysis, have cleaning
4
2.3 ISO Standard:
processes that are repeatable and validated and where Visual
EN 12464 Light and lighting—Lighting of workplaces—
Inspection can be relied upon to determine the cleanliness of
Indoor workplaces
the equipment at the residue limit justified by the HBEL.
2.4 Federal Regulation:
1.5 The values stated in International System of Units (SI)
21 CFR 211 Current Good Manufacturing Practice for Fin-
units are to be regarded as standard. No other units of
5
ished Pharmaceuticals
measurement are included in this standard.
1.6 This standard does not purport to address all of the
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
safety concerns, if any, associated with its use. It is the
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
responsibility of the user of this standard to establish appro-
Standards volume information, refer to the standard’s Document Summary page on
priate safety, health, and environmental practices and deter- the ASTM website.
3
Available from International Conference on Harmonisation of Technical
mine the applicability of regulatory limitations prior to use.
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 practice is under the jurisdiction of ASTM Committee E55 on Manufac- http://www.ich.org.
4
ture of Pharmaceutical and Biopharmaceutical Products and is the direct responsi- Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
bility of Subcommittee E55.03 on General Pharmaceutical Standards. 4th Floor, New York, NY 10036, http://www.ansi.org.
5
Current edition approved May 1, 2022. Published September 2022. Originally Available from U.S. Government Printing Office, Superintendent of
approved in 2020. Last previous edition approved in 2020 as E3263 – 20. DOI: Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://
10.1520/E3263-22. www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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E3263 − 22
2.5 European Guidance: administration and the result of a structured scientific evalua-
EudraLex Volume 4 Guidelines for Good Manufacturing tion of all available pharmacological and toxicological data
...
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: E3263 − 20 E3263 − 22
Standard Practice for
Qualification of Visual Inspection of Pharmaceutical
Manufacturing Equipment and Medical Devices for
1
Residues
This standard is issued under the fixed designation E3263; 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
1.1 This practice provides statistically valid procedures for determining the visual detection limit of residues and the qualification
of inspectors to perform the visual inspection of pharmaceutical manufacturing equipment surfaces and medical devices for
residues.
1.2 This practice applies to pharmaceuticals [including(including active pharmaceutical ingredients (APIs); dosage forms; and
over-the-counter, veterinary, biologics, and clinical supplies]supplies) and medical devices following all manufacturing and
cleaning. This practice is also applicable to other health, cosmetics, and consumer products.
1.3 This practice applies to allmany types of chemical residues (including APIs, intermediates, cleaning agents, processing aids,
machining oils, and so forth) that could remain on manufacturing equipment surfaces or medical devices that have undergone all
manufacturing steps including cleaning.
1.4 This practice applies only to equipment or devices that have been justified through a Quality Risk Management program to
have an acceptable hazard analysis, have cleaning processes that are repeatable and validated and where Visual Inspection can be
relied upon to determine the cleanliness of the equipment at the residue limit justified by the HBEL.
1.5 The values stated in SI International System of Units (SI) units are to be regarded as standard. No other units of measurement
are included in this standard.
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, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.7 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.
1
This practice 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 Oct. 1, 2020May 1, 2022. Published November 2020September 2022. Originally approved in 2020. Last previous edition approved in 2020 as
E3263 – 20. DOI: 10.1520/E3263-20.10.1520/E3263-22.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E3263 − 22
2. Referenced Documents
2
2.1 ASTM Standards:
E2782 Guide for Measurement Systems Analysis (MSA)
E3106 Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
E3219 Guide for Derivation of Health-Based Exposure Limits (HBELs)
G121 Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents
3
2.2 ICH Guidance:
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
ICH Q9 Quality Risk Management
Q10 Pharmaceutical Quality System
4
2.3 ISO Standard:
EN 12464 Light and lighting—Lighting of workplaces—Indoor workplaces
2.4 Federal Regulation:
5
21 CFR 211.67211 Equipment Cleaning and MaintenanceCurrent Good Manufacturing Practice for Finished Pharmaceuticals
2.5 European Regulation:Guidance:
EudraLex Volume 4 Guidelines for Good Manufacturing Practices for Medicinal Products for Human and Veterinary Use, Annex
6
15: Qualification and Validation
7
2.6 U.S. FDA Standard:Guidance:
Guide to Inspections Validation of Cleaning Processes
Guidance for Industry Process Validation: General Principles and Practices
Guidance for Industry PAT A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
Guidance for Industry Data Integrity and Compliant with Drug CGMP Questions and Answers
2
For referenced ASTM standards, visit the ASTM w
...
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