FDA Foreign Drug Establishment Inspections – Congressional Testimony

Subcommittees of the House Committee on Energy and Commerce heard testimony last week from the Government Accountability Office’s Mary Denigan-Macauley and from Janet Woodcock, Director of FDA’s Center of Drug Evaluation and Research, about the state of FDA’s foreign drug establishment inspection program.

Deborah L. Livornese “Testimony About FDA’s Foreign Drug Establishment Inspection Program: GAO and FDA See Things Differently but Both Would Like to See a Fuller Glass.” FDA Law Blog. 16-Dec-2019

Good summary of recent testimony on FDA inspections outside the USA, especially China and India.

MHRA on Passing the Baton from GPvP to GMP

I love the MHRA Inspectorate blog. They don’t write often, but when they do, good stuff. Here are some of my thoughts on the post on moving patient safety data from determination as part of the pharmacovigilance efforts to labeling to distribution.

Starting in the Good Pharmacovigilance Practice (GPvP) realm, triggers for updates may be identified by pharmacovigilance staff and the corresponding variations submitted by regulatory affairs staff, who will also receive notification of variation approval. At this stage Good Manufacturing Practice (GMP) processes come into play with arrangements for printing the updated leaflets and incorporating these into the supply chain.

MHRA Inspectporate Blog “Passing the baton from GPvP to GMP: Three top tips for protecting patients and staying compliant ” 17 Dec 2019

Unless otherwise stated, updates to patient information leaflets should be introduced within 3 to 6 months of approval” – this is the critical point stressed in this post. The recommendations given in the blog post are solid.

Blog RecommendationThoughts
Check that the end to end process facilitates the timely implementation of updates and that there is seamless transition from written procedures covering GPvP, regulatory affairs and GMP processes. Labeling is often a separate change control process. Integration and simplification in change management is critical and companies should look seriously at balkanization of systems.
Define what is meant by ‘implementation’ of an updated leaflet and make sure this is in advance of regulatory deadlines to prevent the need for batches being re-worked should there be any unexpected delays Effective dates on changes need to take into account deadlines.

Appropriate linkages to ERP and supply chain systems.
Ensure the QP has access to up to date information on the correct leaflet version that should be used at batch certification. Communication, and the use of integrated change management

I also read this morning Teresa Gorecki’s post “Dedicated, Integrated Quality Assurance Systems Critical to Successful Clinical Trials.” All of her points are highly relevant here.

System failures are rarely due to the employee

Between January 2016 and May 2019, you recorded approximately 397 customer complaints related to container closure issues (e.g., approximately 60%), product separation, lack of effect and adverse events. Your quality unit failed to adequately review these complaints, identify trends, and implement effective CAPAs. During the inspection you explained that these lapses in quality system performance were due to underperforming staff, who had since been dismissed. In your response, you attributed these and other quality related issues to under staffing of the quality unit as your business expanded.

Your response is inadequate because you failed to appropriately address your quality unit not performing their required duties. Your firm must provide the quality unit with the appropriate authority, sufficient resources, and staff to carry out its responsibilities to consistently ensure drug quality.

FDA Warning Letter to Teligent Pharma, Inc. dated 26-November-2019

Continuing the trend of making me petrified about generics, this warning letter is a roller coaster read. One big set of failures to actually investigate and apply appropriate resources to the quality unit. And then the management had the gall to blame the employees.

80+ years of quality principles ignored. I personally thought the FDA was being overly nice.

There are basically three questions to answer:

  • Do you have a properly established, staffed, and managed Quality Unit?
  • Does your Quality Unit have appropriate responsibilities and authority?
  • Does your Quality Unit have access to the data it needs to make informed decisions?

New Report Exposes MBTA’s “Questionable” Approach to Safety

A “debilitated” safety department and too-thin maintenance crews are just two of the revelations surfaced by a new report on the MBTA’s safety culture.

Read on www.bostonmagazine.com/news/2019/12/09/mbta-safety-report/

Let’s cut right to the heart of the report’s recommendations:

The panel makes six policy recommendations that are intended “to move the organization to a place where safety is a priority and is culturally integrated into every aspect of their mission.” They include establishing better safety performance indicators, identifying the areas where maintenance is being deferred, implementing stronger data collection, and strengthening the MBTA’s leadership team with “more seasoned” transit professionals.

Where does that seem familiar?