How AI Can Reveal Enforcement Trends in Data Integrity

At the PDA Annual Meeting in late March 2024 in Long Beach, California, Redica Systems CEO Michael de la Torre presented a vision for how artificial Intelligence (AI) can reveal enforcement trends in data integrity inspection findings and the work his company has done to date to realize that vision. He began by referencing a […]

A New Drug GMP Mutual Recognition Agreement Model

A pilot between three drug regulators aims to target aspects of good manufacturing practice (GMP) inspections to include better coverage of what each regulator would like to see evaluated. A feature of this pilot not common to most Mutual Recognition Agreements (MRAs) is a planning phase to ensure the regulator performing the inspection covers the […]

Antibiotic-Resistant Bacteria in Patients Is a Genetic Match to Product Contaminant

FDA has discovered a direct, causal link between a multi-state outbreak of antibiotic-resistant bacteria in 2022 and specific contaminated eyedrop products. The agency’s labs determined a “close genetic match” of isolates taken from eyecare product samples to clinical isolates from patients who used the eyedrops and suffered infections. Samples of an antibiotic-resistant strain of the […]

Health Canada Remote/Virtual and Hybrid GMP Inspections – and Which Your Facility May Expect

Do you know the difference between remote/virtual and hybrid GMP inspections and which may be applicable to your facility and situation? At the 48th annual International GMP Conference held in early March 2024 at the University of Georgia in Athens, Georgia, Health Canada Acting Associate Director of Health Products and Licensing Divisions Teresa Forlini explained […]

Health Canada and TGA Reduce Regulatory Burden for Some Drug Company Approvals

A new memorandum of understanding (MoU) between Canada and Australia provides that each country will officially recognize good manufacturing practices (GMP) inspections conducted outside of their respective jurisdictions and provide Certificates of GMP Compliance (CoC) valid in both countries. Facilities and inspections outside a jurisdiction are known as “extra-jurisdictional.” Only onsite inspections will be recognized […]

Drug GMP Warning Letter Issued Without Facility Inspection

Are there high-risk drugs on the market that do not require an FDA drug application submission, approval, or a facility inspection to be marketed? Yes. We know that FDA can issue warning letters based on website reviews – for example, for obviously false claims or claims not substantiated by data that has been submitted to […]

Looking Outside Your Four Walls at GMP by the Sea

It’s challenging enough to use Quality Management Maturity (QMM) within your own facility, and keeping tabs on suppliers is an even steeper climb. But the clues Redica Systems uncovers in regulatory data allow life sciences companies to complement existing QMM metrics for a much more predictive and proactive approach. “Most companies are using 50 percent […]

FDA Post-Warning Letter Meetings are Not Agency Consultations

After receiving an FDA warning letter, eligible generic drug firms now have the option of scheduling a meeting with FDA to discuss remediation efforts resulting from the deficiencies cited in the letter, as described in a recently released draft guidance. At the PDA-FDA Joint Regulatory Conference on September 20, 2023, in Washington, DC, FDA Center […]

A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part Four

What are some of the product and regulatory challenges companies developing cell and gene therapy (CGT) products may face during late-stage development? At the ISPE Annual Meeting held in Orlando, Florida, in early November, Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) Division of Cellular and Gene Therapies Branch […]

A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part Three

A fundamental tenet for drug product development is that a clear and deep understanding of the product is required to appropriately develop and characterize it. Exploring product attributes early in development will facilitate identifying which critical quality attributes (CQAs) to focus on in later clinical phases. At the ISPE Annual Meeting held in Orlando, Florida, […]
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