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Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
Automaticky přeložený název:
Standardní Guide pro posuzování rizik a řízení rizik, neboť dopady návrh, vývoj a provoz PAT procesů pro farmaceutické výrobky
NORMA vydána dne 15.5.2009
Označení normy: ASTM E2476-09
Poznámka: NEPLATNÁ
Datum vydání normy: 15.5.2009
Kód zboží: NS-45391
Počet stran: 10
Přibližná hmotnost: 30 g (0.07 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Keywords:
critical quality attribute (CQA), manufacturing, Process Analytical Technology (PAT), process understanding, risk management, ICS Number Code 11.120.10 (Medicaments)
Significance and Use | ||||||
This guide is intended to provide guidance regarding the use of risk analysis in the development, day-to-day running, and continuous improvement of pharmaceutical processes incorporating Process Analytical Technology (PAT). Since PAT is defined as being “risk-based” (see FDA Guidance for Industry), it is important that a consistent approach to the use of risk methodologies is adopted, to ensure rapid transfer of process understanding within the development and manufacturing teams, and to the regulators where that is appropriate. 4.2 This guidance only covers those aspects of risk assessment related to “risk to product quality.” Other aspects (such as “risk to patient”) should be covered in the conventional manner. |
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1. Scope | ||||||
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 E 2474, Guide E 2500, 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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2. Referenced Documents | ||||||
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