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ASTM E 3106 : 2017

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
Available format(s)

Hardcopy , PDF

Superseded date

09-06-2018

Language(s)

English

Published date

12-01-2017

CONTAINED IN VOL. 14.05, 2018 Pertains to the life-cycle approach to cleaning process validation, which includes the development, qualification, and verification of cleaning processes.

1.1This 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.

1.2This 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).

1.3The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.4This 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.

1.5This 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.

Committee
E 55
DocumentType
Guide
Pages
9
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

ASTM G 121 : 2018 Standard Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents
ASTM D 8219 : 2019 Standard Guide for Cleaning and Disinfection at a Cannabis Cultivation Center

CFR 21(PTS200-299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 200-299
ASTM E 2476 : 2016 : REDLINE Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary

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