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.<\/p>\n
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.<\/span> Note that safety in this context refers to operational and operator safety, not to patient safety.<\/p>\n E2476-09 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture<\/b><\/p>\nPDF Catalog<\/h4>\n
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\n PDF Pages<\/th>\n PDF Title<\/th>\n<\/tr>\n \n 1<\/td>\n Scope <\/td>\n<\/tr>\n \n 2<\/td>\n Referenced Documents
Terminology
Significance and Use
Principles of Risk Assessment and Risk Control <\/td>\n<\/tr>\n\n 3<\/td>\n Preparation for Risk Assessment and Risk Control <\/td>\n<\/tr>\n \n 4<\/td>\n Application of Risk Assessment and Risk Control to PAT
FIG. 1 <\/td>\n<\/tr>\n\n 6<\/td>\n Use of Risk Assessment to Determine Critical Quality Attributes and Critical Control Parameters for a PAT Process <\/td>\n<\/tr>\n \n 7<\/td>\n FIG. 2 <\/td>\n<\/tr>\n \n 8<\/td>\n Use of Risk Assessment to Evaluate Control in PAT Processes
Keywords <\/td>\n<\/tr>\n\n 9<\/td>\n X1. INFORMATIVE GUIDE TO METHODOLOGIES SUPPORTING RISK ASSESSMENT
X1.1
X1.2
X1.3
X1.4 Identification of Risk Factors
FIG. 3 <\/td>\n<\/tr>\n\n 10<\/td>\n X1.5
X1.6 <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"\n\n
\n Published By<\/td>\n Publication Date<\/td>\n Number of Pages<\/td>\n<\/tr>\n \n ASTM<\/b><\/a><\/td>\n 2009<\/td>\n 11<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":14400,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[167,2637],"product_tag":[],"class_list":{"0":"post-14399","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-120-10","7":"product_cat-astm","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/14399","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/14400"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=14399"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=14399"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=14399"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}