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Type: Article
Section: Industry News > Regulatory
Regulatory
Improve Responses to 483s by Expanding Your Focus
FDA audit observations happen in life science manufacturing. When an issue is found, FDA will be looking to determine if the finding is a one-off, or whether it’s the tip of the iceberg.
September 15, 2022
From left, moderator David L. Chesney, MSJ, principal and general manager, DL Chesney Consulting, LLC with Francis RW Godwin, MBA, office director, OC, CDER, FDA; Daniel DeCiero, consumer safety officer, CBER, FDA; Lance M. De Souza, MBA, director, compliance branch, OMPTO, ORA, FDA; and Marea K. Harmon, consumer safety officer, CVM, FDA.
Regulatory
FDA Perspective: COVID-19 Learnings in Communication, Manufacturing
Dr. Peter Marks: “One thing we definitely learned does not work: you can't keep cold capacity. If you have a facility that's completely cold… then you want to try to bring it up to manufacture vaccines, it just doesn't work well.”
September 12, 2022
Dr. Peter Marks, MD, PhD, director, CBER, FDA.
Medical Device/Packaging
KiiP Tackles Wicked Problems in Package Material Stability
What began as a chat over coffee has led to work on a hypothesis and a white paper with far-reaching potential in saving time and resources in medical device packaging stability testing. Efforts were presented at the[PACK]out's inaugural event in Austin.
May 10, 2022
At the[PACK]out, presenting 'Wicked Stability: Predicting the Aging Degradation of Materials' were speakers (from left): Dan Burgess, Henk Blom, and Rod Patch w/ Moderator Seema Momin.
Temp Control/Cold Chain
10 Temperature Monitor Qualification Considerations
From the 2022 ISTA Forum TempPack: Panelists discussed the latest on temperature recording device (TRD) qualification, including dry ice and LCD screens, probes that disconnect, and what to consider before selecting a shipper integrated with a TRD.
April 15, 2022
Speakers from left at TempPack: Mark Maurice, Sensitech; Eric Silberstein, eBiotech Consulting, LLC; Bryan Cardis, Eli Lilly and Company; Arif Rahman, MaxQ Research LLC
Pharmaceuticals
Future for Pharmaceutical Manufacturers Includes More Digitized Data Collection
PMMI
While automation is driving physical changes to pharmaceutical production and packaging processes, another significant shift is occurring in the accumulation and use of data.
March 14, 2022
Getty Images 1161368565
Regulatory
Manage Challenges from the EU 536/2014 Clinical Trials Regulation
Plan ahead for study startup timelines, expiry labeling on primary packaging solutions, and study administration methods.
March 10, 2022
Regulation EU No 536/2014 on clinical trials will come many changes that will impact study startup processes and timelines, expiry labeling on primary and secondary packaging, and study administration methods such as direct-to-patient.
Supply Chain
Tips for Exporting Goods in 2022
Live from Natural Products Expo West: An international trade expert discusses why you need to know your buyers, what you can ship to a sanctioned country, insurance for sea cargo, and more.
March 9, 2022
Pw 7643 Web Cargo
Regulatory
Pitfalls to Avoid in FDA Aseptic Manufacturing Inspections
From personnel to facility design to process, FDA policy advisor provides an outline of what facilities can improve on.
January 5, 2022
Aseptic processing is one of the highest risk pharmaceutical operations, and thus requires a high level of control.
Traceability/Serialization
Counting Down the Top 10 Articles of 2021 - #1: Serialization 101
Join us as we look back at the most-read Healthcare Packaging stories of 2021. At #1, we’re going back to basics with an introductory look at serialization, required by pharma and medical device regulations to defend against counterfeiting.
January 4, 2022
Serialization Master Data 60a571e0dae99
Robotics/Automation
Counting Down the Top 10 Articles of 2021 - #4: Data and AI Accelerate Digital Transformation
Join us as we look back at the most-read Healthcare Packaging stories of 2021. At #4, we cover the growing need for pharma manufacturing facilities to become digitalized to improve productivity and make the most of the ‘digitally native’ workforce.
December 29, 2021
Getty Images 1208358564 6073d57fe5816
Traceability/Serialization
FDA Discusses Nov. 2023 DSCSA Future State
At the HDA Traceability Online Seminar (Nov. 1-3, 2021), FDA’s Connie Jung, RPh, talked about how DSCSA continues to transform the pharmaceutical supply chain to preserve drug safety and security.
November 30, 2021
Dscsa Getty
Traceability/Serialization
Will Labor Requirements Increase in Meeting DSCSA Milestones?
With many companies either facing or concerned about labor shortages in manufacturing, an expert from Cardinal Health notes that outbound scanning alone may require a 12 to 15% increase in headcount in their operations.
November 18, 2021
For product traceability, outbound scanning alone is expected to increase labor by a minimum of 12 to 15% based on recent time studies, per Cardinal Health.
Regulatory
Applying Modern Technology to Pharmaceutical Production Facilities
Robotics, biometrics, and isolator technology are proving cleaner, faster, and safer than traditional manual methods.
November 16, 2021
Companies are adopting robotics and biometrics initiatives in drug product manufacturing and modern, robust aseptic processing technologies that afford tangible safety benefits to sterile products.
Sustainability
EU Regulators, Recycling, and Healthcare Plastics
Packaging suppliers speak about the openness of regulators to understand the slower nature of life science manufacturers in adopting more sustainable packaging.
November 11, 2021
Hp 107536 Surgical Tools Copy png 2
Traceability/Serialization
HDA Foundation Survey Reveals Uneven Progress on Rx Product Serialization
Healthcare Distribution Alliance (HDA)
With 2023 DSCSA requirements around the corner, findings reveal aggregation has slowed. Now in its sixth year, this survey, released as part of HDA’s Traceability Online Seminar (November 1–3), assesses industry abilities to meet DSCSA requirements.
November 1, 2021
Screen Shot 2021 11 01 At 7 04 22 Am
Regulatory
Four DSCSA Guidances Were Released this Summer: Are You Up to Date?
Read what’s new on DSCSA regarding suspect and illegitimate product, product identifiers, and enhanced drug distribution security at the package level.
August 27, 2021
Hda Logo
Regulatory
Fresenius Kabi Goes Above and Beyond DSCSA Requirements
With the support and standards of GS1 US, the pharmaceutical manufacturer fulfills customer needs for an additional system to ensure safe use of medication on a unit-of-use level.
August 12, 2021
Photo credited to Fresenius Kabi.
Cannabis
One Step Closer to Cannabis Access for Medical Research
After years of dragging their heels on approving marijuana cultivation applications for research, the DEA looks to be moving forward with licenses soon.
May 18, 2021
As Marijuana Business Daily's Omar Sacirbey writes, “The move will allow greater research into marijuana and its potential medicinal properties.'
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