Quantcast
Channel: DR ANTHONY MELVIN CRASTO Ph.D – New Drug Approvals
Viewing all articles
Browse latest Browse all 1640

Drafts of revised USP plastic packaging chapters and : removal of the biological reactivity test for oral and topical dosage forms

$
0
0

DRUG REGULATORY AFFAIRS INTERNATIONAL

In a recent Pharmacopeial Forum two revised USP general chapters have been published for comment. With these drafts, the USP expert committee is removing the requirement for <87> Biological Reactivity Tests, In Vitro testing for packaging materials and systems for oral and topical dosage forms. Read more about the draft chapters of <661.1> Plastic Materials of Construction and <661.2> Plastic Packaging Systems for Pharmaceutical Use.testing for packaging materials and systems for oral and topical dosage forms. Read more about the draft chapters of <661.1> Plastic Materials of Construction and <661.2> Plastic Packaging Systems for Pharmaceutical Use.

read

http://www.gmp-compliance.org/enews_05453_Drafts-of-revised-USP-plastic-packaging-chapters–661.1–and–661.2–removal-of-the-biological-reactivity-test-for-oral-and-topical-dosage-forms_15493,15615,Z-PKM_n.html

In Pharmacopeial Forum 42(4) [Jun-Jul 2016] drafts of two revised USP general chapters <661.1> Plastic Materials of Construction and <661.2> Plastic Packaging Systems for Pharmaceutical Use have been published for comment. Deadline for comments is September 30, 2016. With these drafts, the USP General Chapters – Packaging and Distribution Expert Committee…

View original post 2,996 more words


Filed under: Uncategorized

Viewing all articles
Browse latest Browse all 1640

Trending Articles