FDA Compliance Manual For Dietary Supplements

• People also search for FDA CGMP Online Training - trusted FDA GMP online training courses offered by SkillsPlus International Inc.

Updated May 7, 2021

The original link broke.

You can still read more about this topic at:

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 

---  the original post follows below  ---

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.

Return Home: http://drughealth.blogspot.com/

The Health, Drug, Prescription, and GMP Supersite Gift Store

IATA Perishable Cargo Regulations Take Effect

Image via Wikipedia

Updated Jan 18, 2017:

The original post contains many invalid links.

You might still be interested in:
IATA Perishable Cargo Regulations
IATA Time & Temperature Sensitive Labels

= =  original post follows below  = =

Kevin O'Donnell reminds us that the new version of IATA's Perishable Cargo Regulations (PCR) take effect on July 1, 2009, in one of his recent Where Cooler Heads Prevails Blog (http://www.coolerheadsblog.com/) posts, Links to IATA's New Regulations for Time and Temperature-Sensitive Healthcare Products.

In one of his earlier posts, New IATA Regulations Take Effect July 1st, 2009, he writes, "The International Air Transport Association (IATA) will release the 9th Edition of the Perishable Cargo Regulations in June, with the content effective July 1st, 2009. Commonly referred to as Chapter 17, (Air Transport Logistics for Time- and Temperature-Sensitive Healthcare Products), it has undergone considerable revision and represents the airline's pro-active effort to improve handling processes for high-value, high-volume healthcare cargo, including requirements for implementation of a new handling label."

In a nutshell, the 9th edition of the PCR introduces new requirements for the transportation logistics of healthcare products. Amongst these are a new quality management system, training requirements and a new label (mandatory as of July 2010). These changes are the result of the collaboration by carriers with pharmaceutical associations and many other stakeholders in the supply chain, all within a major revision to Chapter 17.

Additional Resources and Materials:
The new IATA “Time and Temperature Sensitive” label and training requirements
The IATA Perishable Cargo Regulations manual

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog