Tiêu chuẩn quốc tế
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Số hiệu
Standard Number
ASTM E2476-16
Năm ban hành 2016
Publication date
Tình trạng
A - Còn hiệu lực
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Tên tiếng Anh
Title in English Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
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Chỉ số phân loại Quốc tế (ICS)
By field |
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Số trang
Page 10
Giá:
Price Liên hệ / Contact us
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Phạm vi áp dụng
Scope of standard 1.1 This document provides guidance on the assessment of risks to product quality within and related to PAT processes in the pharmaceutical industry. It addresses those risks to product quality arising from, associated with, identified by, or modified by the implementation of PAT in pharmaceutical development and manufacturing for primary, secondary, and biotech sectors of the industry. It does not replace those assessments of risk currently undertaken by pharmaceutical companies, but is, rather, an additional component focused specifically upon the evaluation and design of PAT processes. See Practice E2474, Guide E2500, and ICH Q8. 1.2 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. Note that safety in this context refers to operational and operator safety, not to patient safety.
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