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Type: Article
Section: Industries
Regulatory
FDA’s Proposed Change to NDC: Comments Due Nov. 22, 2022
The NDC proposal is intended to minimize the impact of “running out of ten-digit national drug codes (NDCs) by adopting a single, uniform 12-digit format for FDA-assigned NDCs.”
November 1, 2022
Proposed NDC segments and formats. Source: FDA
Labeling/Printing
Tube & Syringe Labeling System with Automatic Tray Unloader
At PACK EXPO 2022, HERMA and Norwalt debuted a combined system that labels at 30 products/min and accommodates containers 12 to 30mm in diameter.
October 26, 2022
Herma & Norwalt Partner At Pack Expo
Packaging/Filling
Intermittent Motion Cartoner at 120/Min
On show at PACK EXPO: In a manual or automatic feeding configuration, the Cariba C221 is compatible with a broad range of common primary packaging formats and features smooth motion and low vibration.
October 24, 2022
MG America Cariba C221
Home
Recycle-ready Monomaterial Sachets
Among a range of sustainable packaging options, Constantia Flexibles is featuring its Perpetua Alta stickpack at PACK EXPO International (Booth W-15031) in the Healthcare Packaging Pavilion.
October 24, 2022
Constantia Flexibles PERPETUA ALTA stickpack.
Materials
Transparent, Mechanically Recyclable Mid-barrier Blister Package
Recyclable polyolefin blister packaging with barrier PP lidding is mechanical recyclability certified via third-party testing. Also: lower-weight reinforced coated paper for medical device applications.
October 23, 2022
TekniPlex Healthcare's fully transparent recyclable mid-barrier blister package. The company reports it is the first time a formed blister + lidding combination is certified as recyclable.
Packaging/Filling
Healthcare Packaging Community Returns to Chicago
Life sciences manufacturing has been tested the past two-plus years. PACK EXPO International in Chicago (Oct. 23-26) offers opportunities to tackle the next hurdles.
October 19, 2022
Screen Shot 2022 10 19 At 11 58 54 Am
Traceability/Serialization
How Missing Traceability Data Might Affect Pharmacy Patients
If accurate and complete pharma traceability data isn't supplied to pharmacists, they may end up scrambling to serve the patients in front of them. Pharmacy leaders discuss how this may affect relationships with nonconforming trading partners.
October 14, 2022
HDA Traceability Seminar dispenser panel (from left): moderator Ronald Bone, HDA Consultant, Ronald N. Bone Consulting LLC; Ian Cannell, Kaiser Permanente; Lisa Schwartz, National Community Pharmacists Association; and Leon Nevers, H-E-B.
Traceability/Serialization
Experts Still Concerned About Exceptions Under DSCSA
Live from HDA's Traceability Seminar 2022: Data issues may cause double the product holdup when a mismatch of product and data are shipped.
October 13, 2022
From left at the HDA Traceability Seminar: moderator Anita T. Ducca, HDA; Matt Sample, AmerisourceBergen Corporation; Arthi Nagaraj, Sanofi US; Julie Malone, Value Drug Company; and Michael Mazur, Pfizer Inc.
Temp Control/Cold Chain
ISTA: Introduction to BioPharma Cold Chain
International Safe Transit Association (ISTA)
Wednesday, October 19th | 10:00 AM - 3:00 PM EST
October 11, 2022
Blue Cap Vial 5f31a2b73db3d
Medical Device/Packaging
Initial Call for Papers! ASTM D10 and F02 Packaging Workshop in Denver
Save the Date: The workshop will take place April 19, 2023 in Denver, CO, with discussion to include case studies, regulations, and more. Submit 300-word abstracts to Workshop Co-Chair Henk Blom before October 18, 2022.
October 10, 2022
The ASTM D10 and F02 Packaging Workshop will be held April 19, 2023.
Traceability/Serialization
DSCSA: Labels Practically as Important as the Medicine Itself
In becoming compliant with interoperable data exchange requirements under DSCSA, don’t overlook the pharmaceutical label itself. Missing case labels or faded inks can pose threats.
October 4, 2022
If wholesalers are unable to read serial numbers or case label information, that product will need to be quarantined, researched, and verified, causing a supply chain disruption.
Adherence/Delivery
Study: Patient Training Gaps Persist for Self-Injection
“If you have a better first experience going into a therapy or medication in that first month or that first try, if you feel comfortable and confident or at least informed, the odds of you staying on that therapy go up significantly,” says Tim McLeroy.
September 20, 2022
The study results showed that patients who have to self-administer are receiving some training, but it’s the quality and type of training that is still lacking or underperforming. (Credit: Noble)
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.
Sustainability
Biomimicry Institute Highlights Startups in Circularity, Waste Reduction
The Ray of Hope Prize identifies nature-inspired startups from around the globe and fosters their growth by providing sustainable business training, communications support, and opportunities for non-dilutive funding.
September 6, 2022
Images are representative of the mycoremediation process. 1. Lab Cultivated fungi applied to shredded waste materials. 2. Waste is myceliated on-site at manufacturers, recyclers, and waste management companies. 3.Biomaterial can be rendered for commercial and or industrial use into new products.
Traceability/Serialization
Perspective: Making Traceability Accessible
In our July/Aug 2022 issue: One system on the horizon creates a digital fingerprint of an item for authentication with the ubiquitous smartphone. Plus: med device stability testing, UDI implementation, and more.
August 26, 2022
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Adherence/Delivery
Study: Pharmacists May Overcome Trust Barriers Among Diverse Patients
One new study reports that 67% of African American and Hispanic patients 50 and older collectively had a more positive sentiment toward pharmacists than doctors. Pharmacists could potentially become a gateway to foster more trust in healthcare.
August 23, 2022
Getty Images 1175230914 5f8dc1752e558 png
Supply Chain
6 Last Mile Considerations for Rare Disease Therapies
A specialty pharmacist discusses the added communication and support—including manufacturers working with patient groups—that foster adherence among smaller patient populations.
August 18, 2022
“The quality or supply chain team may not be putting their patient cap on as much as they’re putting their product integrity cap on, and they might not think about how a dry ice shipment is going to affect the patient,' says Brandon Salke.
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