MHRA, March 2018 ‘GXP’ Data Integrity Guidance and Definitions

Since the 1938 United States Food, Drug and Cosmetics Act was put in place, legal requirements have existed mandating the integrity of the manufacturing and laboratory data supporting product quality and ensuring patient safety.  However, only within the last 10 years has the topic of data integrity been widely discussed and numerous guidance documents (draft and final) have been published.  

Will Public Shaming Stop the Gaming of the System?

Today, the FDA published a list of innovator companies for which FDA has received requests from generic sponsors to request that the Agency intercede in obtaining samples so the generic applicant can conduct the necessary bioequivalence (BE) testing to support ANDA approval.  The FDA has taken this extraordinary approach to provide greater transparency regarding this issue.  

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”.  

With Implementation of Requirements Under the Drug Supply Chain Security Act (DSCSA) Rapidly Approaching, FDA issues Guidance on Waivers

Having attended several conferences where the topic of DSCSA has been discussed, and listening to leading vendors (those that provide both hardware and software) opining on how the industry is behind the eight ball in obtaining equipment and full integration, and validation due to long lead times with the number of vendors available, it appeared logical that a document on the availability of waivers might be in the cards.

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,

So How is that Prescription Drug Imported On-line from Canada?

With all the discussions of reducing prescription costs, the importation of drugs from Canada almost always appears in the debate.  While there are many reputable Canadian on-line and brick and mortar pharmacies from which to import prescription drug products, I have never thought that it was a good idea.  ABC News (here) seem to validate my opposition.

FDA Says the Jolt is Too Much and Potentially Deadly – Caffeine Guidance Describes Restrictions

We do not often blog on the issue of dietary supplements but in this case the FDA is making a serious point by issuing a guidance entitled “Highly Concentrated Caffeine in Dietary Supplements” which can be found here. This comes after several deaths from consumers taking lethal doses of pure or highly concentrated powers or liquid caffeine containing products.

Outsourcing Facilities Make the News Again

On April 12, 2018 FDA posted yet another recall announcement by a registered outsourcing facility (here).  Ever since the New England Compounding Center’s problems associated with the meningitis outbreak, FDA has been diligently inspecting compounders registered as outsourcing facilities with the Agency.  Today’s announcement highlights a continued sterility assurance concern by the FDA.

Median Actions on Inspections Reported By FDA

Under Section 902 of the Food and Drug Administration Reauthorization Act (FDARA) of 2017, the FDA is required to annually publicly report information regarding certain statistics on inspections of facilities associated with the approval of drugs and devices and the impact that they might have had on delaying applications. The calendar year 2017 report has recently issued and the full report can be found here.

Transparency for Decision-Making Process Coming to an Inspection Near You!

In June of 2017, FDA released a document entitled “Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations.”  This white paper/concept of operations (ConOps) reviews the coordinated operational efforts between the Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA).

The anticipated outcomes of the operating model will enable FDA to meet new challenges presented by the complex pharmaceutical industry intricacies. 

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,

Flu the Coop!

Even with this season’s flu season past its peak, FDA is warning consumers about potential fraudulent product touted as curing or lessening the flu.  The FDA health fraud alert (here) warns consumers to be aware of fraudulent product claiming to treat, prevent, or lessen flu symptoms.  In addition, they also warn patients to be wary of online pharmacy sites that may offer unapproved or fraudulent anti-viral products.

Defining Suspect and Illegitimate Products Under the Drug Supply Chain Security Act (DSCSA)

The FDA has issued a guidance (here) that provides clarification on the definitions of suspect and illegitimate products under the  Drug Supply Chain Security Act (DSCSA).  The definitions are designed to help those in the supply chain better and more accurately characterize problem products they may uncover.

The guidance provides the following definitions:

SUSPECT PRODUCT—The term ‘suspect product’ means a product for which there is reason to believe that such product —

(A) is potentially counterfeit,

Compounding Fairness???

As the compounding Industry awaits the next round of Guidances from FDA on using bulk drug substances, one point of controversy appears to be the fairness of compounding for 503A and 503B entities. The most recent Guidances for Compounding from Bulk Drug Substances are:

Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food,