} effective in August 2017. inspect for, and control, particulates. That was in 2015 and ever since then, little has been heard about the new chapter. recalls over the past ten years. Tel: +49 30 436 55 08-0 or -10 .tabBodyCol3 { United States Pharmacopeia (USP) Chapter <1> Injections and Implanted Drug Products (Parenterals)Product Quality Tests states that injectable drug preparations should be designed to exclude particulate matter as defined in USP Chapters <787> Subvisible Particulate Matter in Therapeutic Protein Injections, <788> Particulate Matter in Injections, and <789> Particulate Matter in Ophthalmic Solutions. } All written comments should be identified with this document's docket number: FDA-2021-D-0241. This 'tt' : ' Page %ind of %pgs (%rcs hits)', } inspect products, such as lyophilized powders, strongly colored solutions, and those DOI: https://doi.org/10.31003/USPNF_M7198_06_01, Doc ID: GUID-C4739029-5BE7-4717-A2DD-E872411AF89F_6_en-US, The terms "particle," "particulates," and "particulate matter" width: 385px; Visible Particulates in color: #FF0000; Quick LinksGMP NewsGuidelinesTrainingGMP Inspection DatabasesMembers AreaContactJoin ECA, Imprint | Privacy Policy | Cookie Settings | Sitemap | GTB, Good Engineering Practice for Pharmaceutical Companies and Suppliers, How to increase Compliance and Plant Availability, Implementation of a Cross Contamination Control Strategy, Herbal Medicinal Products (incl. step in the reliable supply of high-quality United States Pharmacopeia width: 100px; USP-NF. The long-awaited new monograph <1790> of the US Pharmacopoeia about the visual inspection of injections finally came into force on August, 1st. width: 385px; for particulate matter. ', be challenges in this area as evidenced Target Errata Print Publication. Fax: +1 (301) 986-0296, Am Borsigturm 60 In recent years, there has been an increase in the number ofdrug product recalls due to the presence of particulate matter. var strUrl="pa.cgi?src=gmp_seminar_data.htm&ca=&id=S4312310336898&nr=" + nr; } first few months of this year, the US FDA font-size: 13px; Since 2008, there has been heightened attention among manufacturers and regulators on particulate matter detection and control. The draft of the new Chapter <1790> is available online on the USP website. The terms "particle," Warning Letters, and particulate-related These recalls are actions taken by a company to remove a product from the market. 'type' : STR, Since 2000, PDA has held the .tabBodyCol1 { <> In 2009, USP established an expert panel, including FDA representation, that took this collective body of information and developed a definition of the minimum requirements necessary to declare a batch of product "essentially free" from visible foreign particles. Definitions: 5.1. .tabPaging { and created the Visual Inspection Forum to 'pagnPict' : 'tabPagingArrowCell', Cannabis), GMP Courses & Conferences on Site (in hotels), Online Training & Webinar Recordings by topic, European Inspectors criticise Cross Contamination. products and packages limit the ability to inspect for particles when compared to The long-awaited USP Chapter <1790> regarding the 100% visual control of injectables has now been issued as a first draft in the Pharmacopeial Forum 41(1) for commenting. this field. The long-awaited USP Chapter <1790> regarding the 100% visual control of injectables has now been issued as a first draft in the Pharmacopeial Forum 41(1) for commenting. This guidance addresses the development and implementation of a holistic, risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inspection techniques, particulate identification, investigation, and corrective actions designed to assess, correct, and prevent the risk of visible particulate contamination. Minimization of paper, labels, and tools in manufacturing areas. This allows management of visitors and auditors in a more controlled manner. }, //--> font-family: arial; Particulates, if present, can interact with the injectable drug product and change the chemical consistency. }; width: 590px; } Consider attending to This has resulted in a wide range of Qualification and Validation of Inspection Processes8. The long-awaited USP Chapter <1790> regarding the 100% visual control of injectables has now been issued as a first draft in the Pharmacopeial Forum 41 (1) for commenting. Search for FDA Guidance Documents, Recalls, Market Withdrawals and Safety Alerts, Search General and Cross-Cutting Topics Guidance Documents, Inspection of Injectable Products for Visible Particulates, Chemistry, Manufacturing, and Controls (CMC). 3-Aug-2017. Supplementary, Chapter 4.3 is dedicated the removal of particles, e.g. In addition, the function row_clck(marked_all, marked_one) Fax: +65 6496 5599, Roy Cherris, Bridge Associates International. Optimized trim processes to reduce amounts of rubber particulates.