Quality

CHPA supports the U.S. Food and Drug Administration's (FDA) federal regulations ensuring and enforcing product quality for over-the-counter (OTC) medicine and dietary supplement manufacturers.

CHPA member companies continuously monitor the quality and manufacturing processes of their OTC medicines and dietary supplements. Federal regulations issued by FDA provide the regulatory framework for ensuring product quality, starting with the ingredients in these products and continuing through manufacturing, distribution, and the product’s expiration date. Compliance with federal regulations is evaluated by FDA via regular manufacturing facility inspections. Individual states may also have laws and regulations that impact manufacturing and set standards for product quality. A number of organizations also provide guidelines or standards for ensuring product quality. Taking all these laws and regulations into consideration, a manufacturer develops internal standard operating procedures to document their processes and ensure consistently high-quality products are produced for the marketplace.

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Comments to FDA: Initiation of Voluntary Recalls

Letter regarding the Healthcare Distribution Alliance position on the Draft Guidance for Industry: Initiation of Voluntary Recalls.

Jun 25, 2019

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Submission

Comments to FDA: Identity Testing for DS

The members of the Consumer Healthcare Products Association appreciate the opportunity to provide comments on the interim final rule on the petition to request an exemption from 100 percent identity testing for dietary ingredients.

Aug 9, 2007

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Submission

Comments to USP: New Compendium for Articles Not Legally Marketed in the U.S.

Letter to Dr. Williams regarding "Development of a New Official Compendium, Separate from USP-NF, for Articles Not Legally Marketed in the U.S."

Jan 25, 2005

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Submission

Comments to USP: Development of a New Official Compendium, Separate from USP-NF, for Articles Not Legally Marketed in the U.S.

Jan 25, 2005

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Submission

Letter to FDA: CP from Coalition for 21 CFR Part 11

The Industry Coalition on 21 CFR Part 11 is pleased to submit the attached Citizen Petition to FDA for consideration. The Coalition comprises 13 trade associations representing manufacturers of products including foods, drugs, cosmetics, veterinary drugs, and medical devices.

Sep 17, 2004

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Submission

Comments to FDA: GMPs for Dietary Supplements

We would like to add our voice to the American Herbal Products Association, the Council for Responsible Nutrition, and the National Nutrition Foods Association in supporting the joint industry submission.

Feb 24, 2004

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Submission

Comments to FDA: cGMPs for Dietary Ingredients and Dietary Supplements

CHPA supports rules governing the regulation of dietary supplements as a special type of food. The association has long advocated Good Manufacturing Practices for dietary supplements.

Aug 8, 2003

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Submission

Comments to FDA: Part 11, Electronic Records, Electronic Signatures

The Coalition is pleased that FDA has issued guidance that takes a risk-based approach to compliance. We strongly support this approach as a more realistic and effective way to protect public health.

Apr 28, 2003

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Submission

Comments to Minnesota Town Hall: Alternative Medicine

Oral testimony of the Consumer Healthcare Products Association to the White House Commission on Complementary and Alternative Medicine Policy.

Mar 16, 2001

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Submission

Comments to FDA: Psyllium

Letter to Charles Ganley, M.D. regarding the agency's determination and comments pertaining to psyllium.

Oct 23, 2000

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FAQs

FAQs About Manufacturing Quality

Learn about how CHPA member companies ensure that OTC medicine quality is standardized across the U.S.

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The Product Quality Research Institute (PQRI) is a non-profit consortium of that generates and shares timely, relevant, and impactful information to advance drug product quality and development. PQRI provides a unique forum to focus critical thinking, conduct research, exchange information, and propose methodology or guidance to pharmaceutical companies, regulators, and standard-setting organizations.

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