Quality

CHPA strongly believes that companies should continue to utilize a set of robust metrics to drive internal continuous improvement activities to enhance product quality and ensure consumer safety.

CHPA's comments on this Draft Guidance are organized into three General Comments and Detailed Comments by Section.

CHPA supports advancing modernization of USP's quality monographs, updating and improving the compendial test methods and establishing product standards which can provide an additional measure of safety for OTC products.

CHPA supports improving the compendial test methods and establishing product standards for levels of elemental impurities which can provide an additional measure of safety for OTC products.

Letter to Dr. Shawn Dressman regarding U.S. Pharmacopeia's Stimuli article: USP's Monographs in Support of FDA's OTC Monograph System: Modernization Opportunities.

CHPA applauds the approach for creating a public forum to collect current research and comments to advance the science of engineered nanomaterials.

These comments are submitted on behalf of CRN and CHPA in response to the FDA Notice and Request for Comments on the implementation of section 301(ll) of the Federal Food, Drug, and Cosmetic Act.

The following comments represent a consolidated set of comments from organizations that have decided to form an Industry Coalition for Rational Implementation of USP <467> to express industry’s concerns with FDA’s implementation of <467>.

The Structured Product Labeling OTC sub-team, under the coordination of CHPA staff, appreciates the opportunity to comment on the "Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing".