FDA Compliance Manual For Dietary Supplements

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Updated May 7, 2021

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FOOD AND DRUG ADMINISTRATION - COMPLIANCE PROGRAM GUIDANCE MANUAL - CHAPTER 21 – FOOD COMPOSITION, STANDARDS, LABELING, AND ECONOMICS - DIETARY SUPPLEMENTS – FOREIGN AND DOMESTIC INSPECTIONS, SAMPLING, AND IMPORTS (IMPLEMENTATION DATE: 09/30/2020) - PDF | FDA.gov 

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The FDA recently made the following available online, Dietary Supplements, Import and Domestic - Ch 21 Food Composition, Standards, Labeling, and Economics - Food and Drug Administration (FDA) - Compliance Program Guidance Manual.

It's a great reference that should be reviewed by everybody in the dietary supplement sector. Of note:

1. Part III - Inspectional - a wonderful listing of things to pay attention to, in almost checklist fashion
2. Part V-A - GMP Violations - watch out! Don't commit any of these major deviations:

• Lack of master manufacturing records or significant requirements not included
• Lack of finished product release criteria or failure to test (all or subset of finished batches) or meet finished product release criteria critical to product safety and quality
• For significant dietary ingredients, e.g. those that make up the bulk of the product, failure to establish specifications for incoming material or failure to conduct identity testing
• No quality control review procedures or significant quality control procedures not implemented
• No batch records
• Significant physical plant deficiencies.

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FDA Launches New Tobacco Products Center

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The Food & Drug Administration (FDA) has launched its new FDA Center for Tobacco Products. The Center will oversee the implementation of the Family Smoking Prevention & Tobacco Control Act signed by President Obama in June 2009. The FDA's responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products and establishing and enforcing advertising and promotion restrictions.

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FDA GMP - Tips on Penicillin Drugs

Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)

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Here's a little refresher in the form of 4 questions, answered by the FDA, Questions and Answers on Good Manufacturing Practices Questions and Answers on Good Manufacturing Practices - Penicillin Drugs.

In a nutshell, all penicillin finished pharmaceutical manufacturers, including repackers, are required by the CGMP regulations to establish a comprehensive control strategy designed to prevent cross-contamination of other drugs with penicillin. These requirements include:

• 21 CFR 211.42(d): Separation of facility and equipment
• 21 CFR 211.46(d): Separate air handling systems (HVAC)
• 21 CFR 211.176: Test for traces of penicillin where possible exposure exits.

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2009 FDA Orange Book Online - Brand New 29th Edition
Easy FDA Orange Book Search Widget
About The FDA Orange Book - Slide Deck (free)
FDA Orange Book - Online

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FDA Final Guidance On ICH Q10 - Quality Control System

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If you follow quality issues in the GMP regulated industry space, you'll want to get up to speed on ICH Q10. Here's what the FDA has to say about this new guidance, FDA - Q10 Pharmaceutical Quality System:

This internationally harmonized guidance is intended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system. Throughout this guidance, the term pharmaceutical quality system refers to the ICH Q10 model. ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) quality concepts, includes applicable good manufacturing practice (GMP) regulations, and complements ICH "Q8 Pharmaceutical Development" and ICH "Q9 Quality Risk Management." ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements. ICH Q10 is not intended to create any new expectations beyond current regulatory requirements. Consequently, the content of ICH Q10 that is additional to current regional GMP requirements is optional.

In summary, the International Conference on Harmonization's (ICH) Q10 attempts to provide a comprehensive model for an effective quality management system by building upon good manufacturing practices (GMP). 

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Residual Solvent Coalition Formed - Gets FDA Attention On USP Chapter 467

Updated May 31, 2021

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FDA Answers Key Residual-Solvent Testing Questions - PharmTech.com

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When the FDA published its recent guidance document on residual solvents in drug products, it resulted in confusion and generated many questions. This recent PharmTech Talk post does an excellent job of framing the difficult situation, "Residual Solvent Concerns Lead to Coalition." In a nutshell, here are some of the important points PharmTech Talk makes . . .

1. Industry has experienced a number of problems and confusion regarding the draft guidance and communications received from FDA’s Office of Generic Drugs, that seem to conflict with Chapter 467
2. There have been so many problems that some core industry groups formed the Coalition for Rational Implementation of USP General Chapter <467>
3. The coalition had four key areas of concern: 1) testing versus control, 2) identification of Class 3 solvents, 3) use of Class 1 solvents, and 4) need for immediate relief while awaiting revised guidance.

Stay tuned, as there's hope the FDA will respond within the next couple of weeks. 

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