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. […]
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 […]
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 […]
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 […]
Our latest video in the Lachman Consultants Data Integrity Series, “People and Organization – The First Essential Elements of a World-Class Data Integrity Program” reveals how good people and organization practices can have a most pronounced impact on reducing your overall data integrity risk. How well is your company incorporating people and organization into its […]
Join Lachman Vice President John McShane and Executive Director Keith Lamb with Arnold & Palmer attorneys Howard Sklamberg and Phillip DeFedele for a live webinar, FDA Manufacturing Compliance and Inspections for Cell and Gene Therapies and Other Innovative Biologics. The 1 hour session will be held on September 15 at 1:00 pm EST. Cell and […]
Within the draft ICH Q14 “Analytical Procedure Development” guidance document (here), Section 6 refers to the Analytical Procedure Control Strategy. This should be developed prior to and confirmed via Analytical Method Validation. A key component of the Analytical Procedure Control Strategy is System Suitability (SST), but the guidance document also makes reference to sample suitability: […]
In-person conferences continue to emerge as evidenced by the recent “GMP by the Sea” held on August 15, 16, 17th in Cambridge, MD. A well balanced conference, led by regulatory leaders, provided relevant “look backs” as well as prospective “look forwards” giving attendees a collective perspective of learning from the past as well as a […]
The EU recently issued the comprehensive GMP Annex 1 for the manufacture of sterile drug products. This guidance is broad and thorough covering all aspects of sterile product manufacture. Under the Quality Control section, (10.5) the following is referenced: The sterility test applied to the finished product should only be regarded as the last in […]
Today, the FDA released an alert (here) warning of potential cross-compatibility issues with the use of autoinjectors for injection of the glatiramer used for the relapsing‑remitting form of multiple sclerosis. The alert is directed at patients, caregivers, and healthcare providers. The FDA says it has “has received reports that using an autoinjector that is not […]
