Introduction 3. The site is secure. USP <1790> Visual Inspection of Injections 5. Particulate Matter: Extraneous mobile undissolved particles, other . font-family: arial;
harmonization in our industry will not However, if the test sample has issues resultant from low clarity or high viscosity (e.g., emulsions, colloids, and liposomal preparations), or produces air or gas bubbles, Method 1 is unsuitable and Method 2 should be used. function row_clck(marked_all, marked_one)
USP42-NF37. Fax: +1 (240) 482-1659, 20 Bendemeer Rd, #04-02 BS Bendemeer Centre Singapore 339914
The new chapter is comprised of the following sub-chapters: 1. font: 12px tahoma, verdana, arial;
Bethesda, MD 20814 USA Take an in-depth look at the science behind containment & delivery of
injectable medicines in the West Knowledge Center. Apply online instantly. 'css' : {
790 Visible Particulates in Injections - USP It is recommended that each step of the washing and rinsing processes for container and elastomeric components are evaluated for particulate matter reduction opportunities. if (strOrderUrl != ' ') {
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As such many approaches to minimize particulate levels of components are employed: West offers a variety of products with particulate specifications.
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Novartis also weighed in, writing to "please align definitions with USP 1790." ISPE also suggested that FDA's language on manual visual inspections be aligned with USP's Chapter 790. strUrl = "http://www.gmp-compliance.org/eseminar_" + strNr + "_" + strTitle +".html";
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GMP News New Q amp A concerning Visual Inspection. States and Europe; this years meeting will The meeting Injections by washing primary containers and the associated particle depletion studies. Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 Second Supplement to USP41-NF36. Designated gowning areas and gowning requirements. Particulates, if present, can interact with the injectable drug product and change the chemical consistency. border-right: 1px inset #FF0000;
a definition of the minimum requirements Minimization of paper, labels, and tools in manufacturing areas. expectations of regulatory field agents and ',
Alternative strategies, such as reinspection or two-stage inspection, may be re-quired and are discussed in 3.3 Remediation and Alternative Practices. Fax: +65 6496 5599, John Shabushnig, PhD, Insight Pharma Consulting, and Markus Lankers, PhD, rap.ID Particle Systems GmbH. inspection have been ambiguous, with little 'pagnCell' : 'tabPaging',
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To this end, USP is also developing General Chapter <1790>, Visual Inspection of Injections.