ASTM E2475-10(2016)

Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

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STANDARD published on 1.9.2016

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The information about the standard:

Designation standards: ASTM E2475-10(2016)
Note: WITHDRAWN
Publication date standards: 1.9.2016
SKU: NS-650886
The number of pages: 7
Approximate weight : 21 g (0.05 lbs)
Country: American technical standard
Category: Technical standards ASTM

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The category - similar standards:

Pharmaceutics in general

Annotation of standard text ASTM E2475-10(2016) :

Keywords:

control, pharmaceutical manufacture, process understanding,, ICS Number Code 11.120.01 (Pharmaceutics in general)

Additional information

1. Scope

1.1 The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical manufacturing using quality by design (QbD) (Juran, 1992;1.2 Process Analytical Technology (PAT) is one element that can be used for achieving control over those inputs determined to be critical to a process. It is important for the reader to recognize that PAT is defined as:

“…a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in process materials and processes, with the goal of ensuring final product quality. It is important to note that the term analytical in PAT is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner. The goal of PAT is to enhance understanding and control the manufacturing process…” (U.S. FDA PAT)

1.3 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.

2. Referenced Documents

E456-13a(2022)	Standard Terminology Relating to Quality and Statistics (Includes all amendments and changes 4/21/2022).
U.S.FDAPAT
	Pharmaceutical Quality Systems
FDA/ICHQ8
E2281-15(2020)	Standard Practice for Process Capability and Performance Measurement
E2617-17	Standard Practice for Validation of Empirically Derived Multivariate Calibrations
E2474-14	Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020)

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