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Letter regarding the Healthcare Distribution Alliance position on the Draft Guidance for Industry: Initiation of Voluntary Recalls.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

Browse Quality Content

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Podcast

CHPA Chat - Probiotic Supplements and Quality Guidelines

Join Duffy MacKay, Senior Vice President of Dietary Supplements at CHPA, and George Paraskevakos, Executive Director of the International Probiotics Association to explore the science behind probiotics, why gut health is so important, and what’s next for this growing category.

Jun 13, 2022

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Submission

Comments on the Proposed Rule: Medical Devices; Quality System Regulation Amendments

CHPA supports efforts to harmonize the current Quality System Regulation with international quality management system requirements. However, CHPA recommends that FDA address several points of concern or clarification when finalizing the Proposed Rule.

May 24, 2022

Weekly Voice Teaser

Weekly Voice

Senate Judiciary Committee Holds Hearing: "Protecting Against Stolen, Counterfeit, and Unsafe Goods Sold Online"

This week, the Senate Judiciary Committee held a hearing to look into legislative solutions to protect consumers who purchase goods on online platforms, namely the INFORM Consumers Act.

Nov 3, 2021

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Press Releases and Statements

ACI, CHPA Applaud FDA’s Withdrawal of Temporary Hand Sanitizer Manufacturing Guidance

ACI and CHPA praise FDA for announcing the withdrawal of its temporary guidance for the manufacturing of alcohol-based hand sanitizer products.

Oct 12, 2021

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Press Releases and Statements

CHPA Files Amicus Brief with 9th Circuit U.S. Court of Appeals

This week CHPA filed an amicus brief urging the 9th Circuit U.S. Court of Appeals to confirm an appellate panel’s holding that a class in a class action lawsuit cannot be certified with more than a de minimis number of uninjured class members.

Sep 9, 2021

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Submission

Brief Amicus Curiae of CHPA in Support of Bumble Bee Foods LLC.

CHPA’s argues both constitutional precedent and federal rules on class action lawsuits require classes that capture members who actually have a viable claim and potential right to recovery; not classes in which some consumers are even plausibly harmed.

Sep 7, 2021

Weekly Voice Teaser

Weekly Voice

CHPA Files Amicus Brief on Class Action Standards

CHPA this week filed an amicus brief urging the 9th Circuit US Court of Appeals to confirm an appellate panel’s holding that a class in a class action lawsuit cannot be certified with more than a de minimis number of uninjured class members.

Sep 7, 2021

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Press Releases and Statements

CHPA Will Feature FDA Leadership, Industry Experts During Virtual Regulatory Conference

Janet Woodcock, Cara Welch, other consumer healthcare leaders to discuss emerging trends in OTCs, dietary supplements, and consumer medical devices

Aug 12, 2021

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Press Releases and Statements

“Quality and Safety” Concerns Should Lead FDA to Withdraw Temporary Hand Sanitizer Manufacturing Guidance

In a new letter, ACI and CHPA call on FDA to withdraw its temporary guidance for the manufacturing of alcohol-based hand sanitizer products.

Apr 29, 2021

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Submission

Joint Letter to FDA Regarding Temporary Hand Sanitizer Guidance

The American Cleaning Institute (ACI) and the Consumer Healthcare Products Association (CHPA) request that FDA withdraw its Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).

Apr 28, 2021

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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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