Revised USP chapter <3> Topical and Transdermal Product Quality Tests

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

The revised USP general chapter <3> TOPICAL AND TRANSDERMAL DRUG PRODUCTS - PRODUCT QUALITY TESTS has been approved for USP42-NF37, second supplement. The draft chapter was published for comment in Pharmacopeial Forum PF 44(5) [Sept.-Oct. 2018].

The second supplement to USP 42–NF 37 will be released in June 2019 and will become official on December 1, 2019. According to the draft the revised general chapter <3> will introduce changes under the following Monograph sections:

• 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.

More detailed Information can be found in the USP general chapter <3> Topical and Transdermal Drug Products - Product Quality Tests.