FAR from Reality – Q&A Document Provides Answers to Age Old Questions

In my 44 years in the industry, I don’t think any issue has raised as many questions, caused companies to scratch their heads or raised the level of angst more than the issue of the dreaded Field Alert Report (FAR).  Well now – and finally – the FDA has issued a Q&A document that answers many of those head- scratching questions.

Valsartan API impurity Leads to Recall of Some Products

Very seldom do we see a notice of recall that relates to a change in the manufacture or processing of the Active Pharmaceutical Ingredient (API), but that is what appears to have happened in this instance.  The FDA announcement states:

The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan,

Petition to Request an Exemption from 100‑Percent Identity Testing of Dietary Ingredients

“Part 111 (21 CFR part 111) establishes the minimum Current Good Manufacturing Practice (CGMP) necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement.”  21 CFR 111.75(a)(1) of these regulations provides a process whereby a dietary supplement manufacturer can petition the Agency for an exemption for 100% identity testing for dietary ingredients. 

CDER Outlines Actions on Drug Shortages

Late yesterday, Dr. Douglas Throckmorton, Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, issued a statement on the FDA’s ongoing efforts in the area of drug shortages.  Based on our post yesterday (here), which outlined the FDA’s new report on drug shortages for 2017, we felt it was necessary to provide a link to Dr.

Bitsy EVA to KASA Grande

Those of us who were around in the Regulatory Affairs field during the late 90s probably remember the glory days of ESD, EVA, and CDOC, following the years of page-stamping in hallways that resembled assembly lines.  Then came EVA, which was part of a system called the Electronic Submission Program, which was in turn, part of a larger strategy for electronic regulatory submission and review at the FDA.

FDA Without Borders! Modernization of Drug Review Office

Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research recently proposed changes to CDER’s new drug regulatory program.  The proposals (here) include regulatory and review process changes, as well as organizational restructuring.  The drive behind these changes are to free up resources so that the reviewers have more time to focus on drug development.  

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Issued by the FDA

This formal ICH Guidance document (here) describes the entire post-approval lifecycle management of changes that are to be made after initial approval of a regulatory submission.

The document is quite comprehensive but, as always, because of inherent differences in the various regulatory authorities, there are limitations to its universal application.  

Got Life? – Check Out the Analytical Procedure Lifecycle

During 2017, the USP issued a Stimuli article for a proposed new chapter, titled “The Analytical Procedure Lifecyle <1220>”, which incorporates the concept of Quality By Design (QbD) and the principles of ICH Q8-R2, Q9, and Q10 for the development and management of analytical test procedures.

There are three lifecycle phases:

  • Procedure Design and Development
  • Procedure Performance Qualification
  • Continuous Procedure Performance Verification

A cornerstone of the design and development phase is the establishment of the Analytical Target Profile (ATP).  

Is the FDA Telling You Something?  Final Bioanalytical Guidance May Point the Way!

Earlier last week, the U.S. FDA released its final guidance document, “Bioanalytical Method Validation.”  This is great news as the bioanalytical industry has been waiting for the draft guidance (issued September 2013) to be finalized.  For all bioanalytical laboratories that were following the previously issued final guidance, “Bioanalytical Method Validation” issued in May 2001, or the draft guidance,

Q & A cGMP for APIs – a Deeper Dive

Since its appearance in August 2007, the Guidance for Industry, ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients has stood the test of time in providing clear and practical guidance to the pharmaceutical industry, as described in the guidance’s original objective, “provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality”.  

ICH Q7 cGMPs for APIs Q&A Guidance Issues

Today, FDA published guidance titled “Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients – Questions and Answers.”  FDA explains that, since ICH Q7 has published, there have been many questions raised by firms, both domestic and international, requesting clarification on issues raised in the ICH document.

The Q&A document referenced above responds to those questions. 

Got Some Time on Your Hands – New Quality Guidance for MDIs and DPIs Issues

On April 18, 2018, the FDA issued a revised draft guidance on Metered Dose Inhalers and Dry Powder Inhalers titled “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations Guidance for Industry”.  The original guidance was published November 13, 1998.  The revision spans some 50 pages of discussion about critical quality attributes,

AAM Testifies at Opioid Hearing

Today, the AAM is providing written testimony to the Committee on Energy and Commerce Subcommittee on Health addressing Combating the Opioid Crisis: Prevention and Public Health Solutions, the full text of which can be accessed through the AAM website (here ).

The testimony addresses the following major points.

  • It is critical that we combat the misuse of prescription medication while maintaining legitimate,