Quality

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We are supportive of the International Pharmaceutical Excipient Council of The Americas' recommendations detailed in their correspondence that USP remove references to dietary supplements and their ingredients.

Jul 27, 2017

Letter regarding modernization of the USP compendia for OTC medicines. CHPA supports improving the compendial test methods and establishing product standards for safety.

Jul 27, 2017

Our member companies generally support the recommendations found in the guidance but have concerns about the scope of hardness measurements and maximum break strength value.

Aug 16, 2016

CHPA supports improving the compendial test methods and establishing product standards for the variety of dosage forms, which can provide an additional measure of safety for OTC products.

Nov 30, 2015

CRN, CHPA, and their member companies are concerned with and offer the following comments to the proposed revisions to the USP-NF General Chapter <467> on Residual Solvents.

Nov 27, 2015

Comments regarding the Agency’s goals behind the proposed quality metrics program.

Nov 25, 2015

Our member companies support the concept that well-designed metrics are critical in driving and measuring continuous improvement activities in both quality systems and improving manufacturing processes.

Nov 24, 2015

CHPA is generally supportive of the revision proposal to update and clarify the Chapter. We would however request that the implementation be delayed for 24 months.

Jul 30, 2015

Letter to Principal Scientific Liaison, U.S. Pharmacopeia, regarding Proposals for Developing Compendial Quality Standards for OTC Drugs.

Apr 3, 2015

In general, the Part 111 GMP requirements, although similar, are less stringent and tend to be more flexible than the Part 211 GMP requirements.

Mar 4, 2015

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