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Letter regarding the Healthcare Distribution Alliance position on the Draft Guidance for Industry: Initiation of Voluntary Recalls.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

The Annual Forecast for Planned Monograph Activities describes planned monograph activities that FDA intends to address over the ensuing three years.

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Guideline for the Stability Testing of Nonprescription (OTC) Drug Products Not Regulated by an NDA/ANDA

The objective of this guideline is to define the minimum stability data package to support the commercial distribution of OTC monograph drug products in the United States per climatic zone.

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Structured Product Labeling

Learn about rules and regulations for structured product labeling of OTC medicines.

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Standardized Information on Dietary Ingredients (SIDI)

The Standardized Information on Dietary Ingredients (SIDI) Work Group has released three voluntary guidelines, intended to help the dietary supplement industry comply with cGMP regulations.

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Industry Self-Regulation for Dietary Supplements

SIDI Protocol Version 3.0

The Standardized Information on Dietary Ingredients (SIDITM) Protocol is intended to serve as a standardized format that can be used consistently across the dietary supplement industry.

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Background Summary: Anticaries Test Methods

Since the Final Rule was published in 1995, FDA has received six Citizen Petitions (CPs) requesting the addition of alternatives to the animal caries test to the Anticaries Monograph.

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Voluntary Guideline on Impurities in Monograph OTC Topicals Excluding NDA and ANDA Products

This white paper provides guidance for the evaluation and reporting of impurities in OTC monograph drug products formulated as topicals and topical rinses. This document serves as CHPA's member company consensus on this complex issue.

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Industry Self-Regulation for Dietary Supplements

Dietary Supplement Component Supplier Qualification

This document serves as a voluntary guideline to assist manufacturers of dietary supplements with compliance with the dietary supplement current good manufacturing practice (cGMP) requirements of the US FDA 21 CFR §111.

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FAQs

FAQs About Standardized Information on Dietary Ingredients (SIDI)

Find frequently asked questions about the Standardized Information on Dietary Ingredients (SIDI).

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Guidelines for the Stability Testing in Support of Changes to Nonprescription (OTC) Monograph Drug Products Not Regulated by an NDA/ANDA

Due to the wide variety of changes that may be encountered after an OTC monograph drug is marketed, it is impossible to address stability requirements for all changes in this guideline. However, guidance from the examples provided here can be used in the decision-making process.

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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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