5/28付のECA/GMP Newsが「Revised USP chapter <3> Topical and Transdermal Product Quality Tests」と題する記事を掲載しています。
USP各条<3>「局所用および経皮用医薬品 - 製品品質試験」が、USP42-NF37の第2追補として承認されたとのことです。
2019年12月1日に正式になる予定です。
以下のような事項が改訂変更されているようです。
・PRODUCT QUALITY TESTS FOR TOPICAL AND TRANSDERMAL DRUG PRODUCTS: Include a procedure for sampling products packaged in containers with a non-metered pump,
・Include a section on IN VITRO DRUG RELEASE TEST,
・SPECIFIC TESTS FOR PHARMACEUTICAL FOAMS: Include a cross-reference to the new Pharmaceutical Foams—Product Quality Tests <607>,
・SPECIFIC TESTS FOR TOPICAL AEROSOLS: Include a cross-reference to the general chapter Topical Aerosols <603>,
・SPECIFIC TESTS FOR TOPICALLY APPLIED SEMISOLID DRUG PRODUCTS: Include revised acceptance criteria under the Uniformity of Active Ingredient(s) section, include procedures for Delivered-Dose Uniformity in Metered Dose Containers and for Pump Functionality Test for Metered and Non-Metered Dose Container Closures.
・SPECIFIC TESTS FOR TDS: Include a revised Peel Adhesion Test, Release Liner Peel Test, Tack Test, and Cold Flow Test, and delete the Rolling Ball Method, and the Determination of the Validity of Static Shear Test.
関係者及び興味のある方は、下記URLのニュース記事をご参照ください。
https://www.gmp-compliance.org/gmp-news/revised-usp-chapter-3-topical-and-transdermal-product-quality-tests
USP各条<3>「局所用および経皮用医薬品 - 製品品質試験」が、USP42-NF37の第2追補として承認さ
2019年12月1日に正式になる予定です。
以下のような事項が改訂変更されているようです。
・PRODUCT QUALITY TESTS FOR TOPICAL AND TRANSDERMAL DRUG PRODUCTS: Include a procedure for sampling products packaged in containers with a non-metered pump,
・Include a section on IN VITRO DRUG RELEASE TEST,
・SPECIFIC TESTS FOR PHARMACEUTICAL FOAMS: Include a cross-reference to the new Pharmaceutical Foams—Product Quality Tests <607>,
・SPECIFIC TESTS FOR TOPICAL AEROSOLS: Include a cross-reference to the general chapter Topical Aerosols <603>,
・SPECIFIC TESTS FOR TOPICALLY APPLIED SEMISOLID DRUG PRODUCTS: Include revised acceptance criteria under the Uniformity of Active Ingredient(s) section, include procedures for Delivered-Dose Uniformity in Metered Dose Containers and for Pump Functionality Test for Metered and Non-Metered Dose Container Closures.
・SPECIFIC TESTS FOR TDS: Include a revised Peel Adhesion Test, Release Liner Peel Test, Tack Test, and Cold Flow Test, and delete the Rolling Ball Method, and the Determination of the Validity of Static Shear Test.
関係者及び興味のある方は、下記URLのニュース記事をご参照く
https://www.gmp-compliance.
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