Assessing Your Readiness State for FSMA: Stabilize, Then Benchmark

Assessing Your Readiness State for FSMA: Stabilize, Then Benchmark

I find that the FSMA readiness of major food brands and CPGs runs the gamut from “scrambling” to “got it covered” — and everywhere in between. Smaller companies have been given more time to prepare by the FDA. Larger companies have considerably less runway to get ready.

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What is the Future of Outsourcing Facilities?

What is the Future of Outsourcing Facilities?

by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief

PART II Policies, Enforcement, and Predictions

Policies:
In this section, we will address policies and guidance that the FDA has published since the end of 2013, look at enforcement activities in this area, and make some predictions for the future of this market segment.

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FDA and MHRA MOST RECENT INSPECTION OBSERVATIONS

FDA and MHRA MOST RECENT INSPECTION OBSERVATIONS

by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief

INTRODUCTION:

Part of a comprehensive GMP Intelligence program is the monitoring of enforcement actions, including FDA 483s, warning letters, recalls, import alerts, consent decree agreements, and EU reports of GMDP noncompliance. This article presents the most recent GMP inspection data from CDER and MHRA.  The CDER data are from inspections conducted in FY2016 and the MHRA data come from inspections conducted in 2015.

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Outsourcing Facilities: Are They Still Worth It and Were They Ever?

The Real Story Behind Outsourcing Facilities:

Are They Still Worth It and Were They Ever?

by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief

PART I History and Background:

The New England Compounding Center (NECC) preparation and shipment of contaminated injectable products across state lines in 2012 created a firestorm of publicity and enforcement actions.  More than 750 patients in twenty states developed a fungal infection, fungal meningitis, and more than 60 people died.  Others became sick and suffered long term harm as reported by Kurt Eichenwald in a Newsweek article of April 2015.   In an abundance of caution, FDA quickly recommended that healthcare providers not use any product from NECC.  The FDA commissioner gave testimony before Congress in November 2012 where they outlined their response and presented FDA’s legal authority over compounded drugs.  In December 2014 fourteen arrests were made.  The owner of the pharmacy was indicted by a federal grand jury and is currently on trial.  He faces racketeering charges and twenty-five counts of second decree murder.  In May 2015, a federal bankruptcy judge approved a $200 million fund to provide compensation to victims. A recent article from the Wicked Local Framingham written by Walter F. Roche Jr., identifies some of the practices that have come to light at the trial.   This event triggered legislative changes, development of more than two dozen guidance documents, and changes in inspection practices for a niche area of drug preparation within the United States.

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FDA Sent These 10 Warning Letters for Pharma Companies | January 2017

We took a snapshot of the 10 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from products not meeting “the definition and standard for chocolate” to sites “refusing to permit the FDA inspection” altogether.

From pharmaceuticals in Italy, Pennsylvania, and more, here they are (starting with the most recent):
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10 Ways to Prepare for a GMP Inspection

How to Prepare for a GMP Inspection for Small and Virtual Companies

by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief

Preparing for GMP inspections, particularly pre-approval inspections, can be a challenge when resources are limited and staff may have little expertise in these important activities. This becomes especially complex for start-up companies that are virtual, or essentially virtual, and rely on contract manufacturers and contract laboratories.  Virtual firms are responsible for the content of the submission, release of product to the clinic or for commercial distribution and post approval safety reporting even though they may not manufacture API or dosage form.  The following are some suggestions for these firms to ensure a successful inspection outcome when they have limited experience in this activity and limited resources:

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