{"id":448685,"date":"2024-10-20T08:58:20","date_gmt":"2024-10-20T08:58:20","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/astm-e2475-2023\/"},"modified":"2024-10-26T16:47:07","modified_gmt":"2024-10-26T16:47:07","slug":"astm-e2475-2023","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/astm\/astm-e2475-2023\/","title":{"rendered":"ASTM-E2475 2023"},"content":{"rendered":"

ASTM E2475-23<\/h3>\n

Active Standard: Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control<\/h4>\n
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ASTM E2475<\/h4>\n

Scope<\/strong><\/p>\n

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1.1<\/span> The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical manufacturing using the principles of quality by design (QbD) (Juran, 1992;2<\/span><\/span> ICH\u2009Q8). The framework is applicable to both drug substance (DS) and drug product (DP) manufacturing. High (detailed) level process understanding can be used to facilitate production of product which consistently meets required specifications. It can also play a key role in continual process improvement efforts.<\/p>\n<\/p><\/div>\n

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1.2<\/span> 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:<\/p>\n

\n <\/div>\n<\/p><\/div>\n
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1.3<\/span> 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.<\/i><\/p>\n<\/p><\/div>\n

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1.4<\/span> This 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.<\/i><\/p>\n<\/p><\/div>\n

Keywords<\/strong><\/p>\n

control; pharmaceutical manufacture; process understanding;<\/p>\n

ICS Code<\/strong><\/p>\n

ICS Number Code 11.120.01 (Pharmaceutics in general)<\/p>\n

DOI:<\/strong> 10.1520\/E2475-23<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

E2475-23 Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
ASTM<\/b><\/a><\/td>\n2023<\/td>\n7<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":448695,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[166,2637],"product_tag":[],"class_list":{"0":"post-448685","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-120-01","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\/448685","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\/448695"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=448685"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=448685"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=448685"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}