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The New FDA GMP Inspection Model

While the drug GMPs haven’t changed much, if at all, in recent years, the FDA is planning for significant changes in how drug GMP inspections are scheduled and conducted. Last year, the FDA made available a description of their new operating model that will ensure integration of review and inspection activities for human drugs. This post dives deep into this model – including new timelines for those of us in the drug industry.

Follow the Trail to Find Data Integrity Problems

How Do I Follow The Trail? One of the most effective audits I ever participated in started with a systems-naive auditor asking a simple question: “Imagine I’m a sample arriving at your loading dock. What happens to me?” We proceeded down the trail together, following the sample through the processes of accessioning, analysis, reporting, and storage. While you can start [...]

CDRH Planned Reorganization Breaks Down Silos and Focuses Expertise by Product Type

The FDA Center for Device and Radiological Health (CDRH) has proposed a reorganization that will collapse the Center’s seven offices into four, combining siloes of expertise into a new office that aligns the expertise into teams by product type and technology.  Individuals from the evaluation and compliance groups for specific product types and technologies will now be on one [...]

5 Ways Manufacturing Quality Problems Can Take Down a Company

Manufacturing quality issues arise from time to time at pharmaceutical, medical device, and food companies, and if left unchecked, can lead to massive losses. Analyzing FDA inspections and a company's performance provides early insights into any potential issues that may be brewing. Almost all quality-related warning letters start with an inspection and a 483. While some warning letters result [...]

The Ultimate Guide to Researching Your FDA Inspector

The trick with any FDA inspection preparedness program is to reduce the risk of surprise by understanding FDA history and tendencies. But like most professionals in this industry, you’re probably busy with a million things on your to-do list.  And while you know you should set up a complete FDA inspection preparedness program, you just [...]

FDA Sent These 3 Warning Letters for Pharma Companies | November 2017

We took a snapshot of the 3 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to have correct expiration dates to failing to investigate the unexplained. From pharmaceuticals in China and India only, here they are (starting with the most recent): […]

Generic Drugs | A Guidance on FDA Guidance

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief On November 1, 2017, we published a blog that addressed a large collection of newly issued guidance for the generic drug industry.  With this post, we continue with another three generic drug guidance that were issued recently.  Consistent with the previous collection, many of these find their roots in [...]

FDA Sent These 6 Warning Letters for Pharma Companies | October 2017

We took a snapshot of the 6 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to prevent “mix-ups” to failing to adequately investigate. From pharmaceuticals in Wisconsin, India, and more, here they are (starting with the most recent): […]

By | 2018-01-26T23:06:27+00:00 November 16th, 2017|Biopharma / Pharma, FDA, FDA Warning Letters, FDAzilla|

New CDRH Guidance in October

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief The FDA has been on a bit of a tear in publishing guidance for devices and generic drugs.  Here we address the CDRH guidance issued between September 29th and October 25th 2017 and provide summaries of their content.  Seven guidance listed below are final, and one is published for [...]

By | 2017-11-09T16:29:42+00:00 November 9th, 2017|510(k), FDA, FDA-Regulated Industry, FDAzilla, Medical Devices|