Ensuring high-quality dietary supplements with 'quality-by-design' - QbD

The U.S. Food and Drug Administration (FDA) regulates dietary supplements as a category of foods, rather than drugs.

Ensuring high-quality dietary supplements with 'quality-by-design':

"They concluded that a QbD approach — ensuring the quality of a product from its very inception — is the best strategy. One key step in applying QbD to dietary supplements, for instance, would involve verifying the identities of the raw materials — the plants — used to make supplements. “It is clear that only a systematic designed approach can provide the required solution for complete botanical characterization, authentication and safety evaluation,” they say."

'via Blog this'

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FDA Guidance On ICH Q8-10

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This FDA guidance, FDA - Guidance for Industry - Q8, Q9, and Q10 - Questions and Answers, reflects the current working procedure of the ICH Quality Implementation Working Group (Q-IWG) for implementing the Q8, Q9, and Q10 guidances.

The guidance, in Q & A format covers:

• Q8 (R2) Pharmaceutical Development (includes the Q8 parent guidance (Part I) and the annex (Part II), which provides further clarification of the Q8 parent guidance and describes the principles of quality by design)
• Q9 Quality Risk Management
• Q10 Pharmaceutical Quality Systems

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FDA Releases Revision To Q8 Pharmaceutical Development Guidance

The FDA released this guidance revision, Guidance for Industry Q8(R1) Pharmaceutical Development, which is a revision of the ICH guidance Q8 Pharmaceutical Development (Q8 parent guidance) that was published in May 2006. The Q8 parent guidance is revised to add an annex, which provides further clarification of the key concepts outlined in the May 2006 guidance and describes the principles of quality by design (QbD). This Q8(R1) document includes the Q8 parent guidance and the annex. This guidance is intended to provide guidance on the contents of section 3.2.P.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use). 

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FDA Quality by Design - QbD - Executive Guide (pdf)

According to Cerulean Associates' Why Quality by Design? - An Executive's Guide to the FDA's Quality by Design (pdf), "Quality by Design is one of the most misunderstood and misused tools available to biopharmaceutical and medical device executives." The guide is easily understood and closes by driving to a 7-step QbD start-up plan. According to the guide, "the best way to assess how to implement QbD in your organization without making the same mistakes that other companies have made is to utilize a simple 7 step process."

Here's to hoping you enjoy and find this guide a good read, as I found it.

Related Posts:
Quality by Design (QbD) For Analytical Methods (video)

#FDA #GMP #training #cGMP

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Quality by Design (QbD) For Analytical Methods (video)

Updated 3/10/2020:

This topic is seriously out of date.  This thread started in 2008.

You might also be interested in this FDA slide presentation from 2011:
Quality by Design Approaches to Analytical Methods -- FDA Perspective

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Updated 8/10/2016:

You might also be interested in this blog post:
FDA Doubles Down on QbD (BioProcess Blog)

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Updated 6/25/2015:

This post didn't age well, the links in the original post are no longer found.

You might also be interested in:   QbD Considerations for Analytical Methods - FDA Perspective

=========  original post below =========

Maribel Ross, Senior Editor with Pharmaceutical Technology, discusses the FDA's quality by design (QbD) initiative as it applies to analytical methods with one of the top experts in this area, Dr. Moheb Nasr, Director of FDA's Office of New Drug Quality Assessment, in this PharmTech TV video, "Live From 2008 AAPS: Analytical Methods for QbD."

#FDA #GMP #training #cGMP

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