5 things we learned at the PDA/FDA Joint Regulatory Conference 2023
Last week, Qualio attended the 2023 PDA/FDA Joint Regulatory Conference for a fact-finding mission in Washington, D.C.
The flagship conference, shared between the Parenteral Drug Association and the Food & Drug Administration, was hosted for the 32nd time in September 2023.
The theme? cGMP: quality through science and innovation.
As an event designed for the regulated pharma and biotech companies that Qualio serves, we couldn't miss it!
Here's what we learned across the 3 days.
1. The FDA is going hybrid
COVID-19 seems to have driven an irreversible change in how the FDA regulates life science companies.
In short? The FDA is going hybrid.
Where physical inspections were once part and parcel of FDA practice, the clear shift to 'remote regulatory assessments' and information requests that took place in 2020 doesn't seem to be going anywhere post-pandemic.
In fact, where inspections - or companies refusing to be inspected - drove 98% of drug adulteration import alert cases in 2018, that figure is only 23% in 2023.
Strikingly, three-quarters of the import alerts this year were triggered by either information uncovered during remote 704(a)(4) record requests, or by companies failing to respond adequately to those requests.
And because Section 3611 of the 2022 FDORA Act expanded the FDA's 704(a)(4) request capability to medical device companies too, this is no longer just a concern for drug organizations.
The takeaway:
The FDA is relying more and more on remote inspections and record requests to keep tabs.
Ensure you have the operational ability to respond to these new inspection demands: digital, cloud-based QMS information looks increasingly expected.
2. The Quality Management Maturity program is picking up speed
CDER first floated the idea of a voluntary pharmaceutical quality program back in 2020.
With quality issues continuing to be the key driver of US drug shortages, with over 100 shortages still dragging on, and with only about 30% of drugmakers properly fulfilling their CARES reporting duties, the FDA is stepping up its plans for its so-called Quality Management Maturity program.
The initiative will see pharmaceutical companies voluntarily commit to moving beyond the bare-minimum baseline of cGMP compliance, directing energy towards both a quality culture and proactive, continuous quality improvement.
As the FDA puts it:
"... drug manufacturers achieve higher levels of maturity when they successfully integrate business and manufacturing operations with quality practices and technological advancements to optimize product quality, enhance supply chain reliability, and drive continual improvement..."
An August 2023 whitepaper throws more light on how exactly the FDA expects drug manufacturers to demonstrate quality maturity.
5 key areas will be inspected in the FDA's 'prototype assessment protocol':
- Management commitment to quality
- Business continuity
- Advanced PQS
- Technical excellence
- Employee empowerment & engagement
A public docket was established for comments and feedback on September 15 - take a look here!
The takeaway:
The FDA wants pharmaceutical companies to progress beyond cGMP and put continuously improving quality front and center.
The QMM Program is picking up speed to fulfil this aim.
Adherence will be voluntary, but the benefits of an advanced and mature PQS, backed by committed leadership and employees and underpinned by technical investment and a business continuity focus, can be transformative for your business.
Do your research and start considering how to weave QMM into your operation.
3. cGMP is distracting
A recurring theme at the conference was that excessive focus on cGMP and ensuring drugs are manufactured properly has created a blind spot regarding critical adjacent quality activities like environmental control.
Environmental monitoring and control of both raw materials and contamination topped the leading causes of warning letters for the 2015-2023 period.
Contaminations loomed large in recall data too, with three of the five most recalled products for 2016-2020 triggered by nitrosamine and methanol contamination.
Environmental and facility management was therefore hammered as a critical area of focus, with this focus spilling over into how suppliers are onboarded and assessed too.
As supply chains grow in both length and complexity, the risk of contamination and adulteration continues to deepen.
Drug companies should therefore ensure that focus on the manufacturing line does not overshadow scrutiny of how those drugs are then distributed and supplied to patients.
The takeaway:
Manufacturing is important - but so is the environment your drug must pass through on its way to patients.
Pay close attention to your supply chain and focus your risk management activities particularly towards contamination, material and environmental monitoring.
4. New super office!
The Office of Tissues and Advanced Therapies (OTAT) was recently reorganized into the Super Office of Therapeutic Products (OTP).
It reflects a growing interest from the FDA in the explosive growth of cell and gene therapies.
8 brand new gene therapies have been approved in the US since the beginning of 2022, a trend which CBER Director Peter Marks said reflected a 'coming of age' for the sector.
The takeaway:
Innovative biologics like gene therapy stand at a critical juncture.
Manufacturing challenges, a diverse patchwork of global regulatory requirements and testing clinical development timelines all stand out as major challenges for the nascent sector.
The FDA is reforming its organizational structure to better work with companies in these areas.
5. New guidance
The world of quality and regulatory never stands still.
The conference was a great way to touch base on upcoming guidance documents and updates for life science companies to dive into.
Final guidance documents
January 2023: Cannabis & cannabis-derived compounds: quality considerations for clinical research
FDA documents coming soon
Pharmaceutical Quality/CMC – omnibus legislation and PDUFA/BsUFA
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- Advanced manufacturing technologies designation program, designated technologies in drug and biological products
- Stability considerations for drug substances and drug products in NDAs, ANDAs, and BLAs and associated labeling statements for drug products
- Use of alternative tools to assess manufacturing facilities named in pending applications
- Post-approval manufacturing changes to biosimilars and interchangeable biosimilars questions and answers
ICH documents coming soon
- ICH Q3E impurity: assessment & control of extractables and leachables for pharmaceuticals and biologics
- ICH Q5A (R2): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
- M4Q (R2) CTD on quality
- ICH Q2/Q14: Analytical procedures
- ICH Q1A-E/Q5C (revision): stability testing
The takeaway:
Keep abreast of current best practice and expectations by doing your research on both draft and upcoming guidance documents from the FDA and ICH.
