Compliance

04
Oct

Facility Not Ready for Inspection Used to Get a Pass but Not Anymore!

As former OGD Director Kathleen “Cook” Uhl, MD used to say, “Read the commitment letter.”  This certainly applies for GDUFA III and in spades.  Why?  Because a number of enhancements that were made in the GDUFA III negotiations are designed to make the review process more efficient and improve the number of first‑cycle approvals. In GDFUA I and […]

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30
Sep

To Average or Not to Average, That is the Question?

Earlier this year, we posted about FDA’s new revision for the OOS Guidance for Industry.  The new revision allows ‘averaging’ results from a pool of replicate results even though one of them is OOS for ‘certain circumstances.’  This was the most significant change in this revision.  So the question is, can you always average?  If […]

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29
Sep

Validation Still the Key to Success

The 16th annual WRIB (Workshop on Recent Issues of Bioanalysis) is being held in Atlanta, GA this week with approximately 800 attendees at the workshop.  The workshop which runs through Friday, is well represented by regulators from across globe, and industry (both from Pharma and CROs) with numerous discussions and topics for bioanalysis ranging from […]

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28
Sep
Quality Agreements Image

Great Quality and Great Business Is Interdependence in Plain Sight?

If our supply chain was weak prior to the pandemic, this global event accelerated its failure.  These signals of weakness were laid bare during the pandemic  and identified in publications such as the 2019 report “Drug Shortages:  Root Causes and potential Solutions” (here).  Prior to the Covid PHE, focus on shortages was placed much more […]

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26
Sep

Data Integrity Series: Episode 4

Episode #4 of our six-part Data Integrity video series focuses on Systems and Processes, two more essential elements for minimizing and eliminating data integrity issues. The video explains the four key points of Systems and Processes necessary for establishing a world-class data integrity program and the two primary controls that well-established Systems and Processes provide. […]

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20
Sep

Remote Non-Inspection “Inspections”

Throughout the PDA-FDA Joint Regulatory Meeting that took place September 12-14, 2022 in Washington D.C., the subject of Remote Assessments (RA), also called Remote Interactive Evaluations (RIEs), was repeated over and over again in sessions.  This is not a new thing, as the Guidance for Industry (GFI), “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch […]

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15
Sep

Changes Forced Upon FDA and Industry Highlighted at PDA FDA Joint Regulatory Conference

At the first in person PDA/FDA Joint Regulatory Conference since the pandemic began, (held September 12-14 in Washington, DC), it was almost impossible to escape the effect that the pandemic had on everyone attending the meeting, regardless of their affiliation. From the inevitable exclamation from presenters at the podium about how great it was to […]

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09
Sep

Annex 1: A Step Increase in Sterile Manufacturing Requirements

A 300% increase in anything gets attention, however, when it is a “rule governing medicinal product in the European Union” it demands attention and action (EudraLex – Volume 4 (europa.eu)).  Annex 1 which is the guide for the “Manufacture of Sterile Medicinal Products” (20220825_gmp-an1_en_0.pdf (europa.eu)) was just released on 22 August 2022.  This document is […]

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