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Section: Industry News > Regulatory
Traceability/Serialization
Graphic Packaging Introducing Advanced Pack Serialization Solution
Graphic Packaging International
The new product will help pharma companies clamp down on counterfeit healthcare products and improve patient safety.
November 2, 2022
Graphic Packaging Serialisation
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
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.
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.
Regulatory
FDA Lists Mechanisms to Comply With CGMP Requirements for CPs
U.S. Food and Drug Administration
While the FDA has provided examples of mechanisms, CP manufacturers should consider the suitability of an approach in the context of their product and manufacturing process.
September 19, 2022
Fda Logo, Hi Res
Regulatory
FDA Issues Medical Device Production Computer Software Guidance
U.S. Food and Drug Administration
The draft guidance provides recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system.
September 15, 2022
Fda Logo, Hi Res
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.
Packaging/Filling
NIST Providing $3M for Biopharma Manufacturing Equipment Advancements
The funding for new equipment will support the advancement of biopharmaceutical manufacturing processes and provide expanded opportunities for workforce development.
September 14, 2022
Niimbl
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.
Traceability/Serialization
HDA Statement on FDA Proposed National Standards for Licensure of Distributors and 3PLs
Healthcare Distribution Alliance (HDA)
“...with the deadline to comply with DSCSA’s final phase almost one year away, time is of the essence. That is why HDA urges FDA to align certain sections of the rule as closely as possible so distributors and 3PLs can comply with parallel provisions.”
September 8, 2022
Hda
Labeling/Printing
Octapharma Employs Schreiner MediPharm Automated Vial Labeling System
Schreiner MediPharm
The Schreiner MediPharm automatic application solution is ideal even for very small quantities.
August 22, 2022
With the semi-automatic dispensing system from Schreiner MediPharm, Octapharma can efficiently mark smallest quantities of containers—from small vials to large infusion bottles.
Packaging/Filling
2022 PDA Pre-Filled Syringes Conference and Parenteral Packaging Courses
Held in Palm Springs, CA, the in-person conference takes place Oct.18 - 19 and the courses follow on Oct. 20.
August 22, 2022
2022 Prefilled 1200x670
Sustainability
FDA Continues Support of Innovation in Medical Device Sterilization
U.S. Food and Drug Administration
A recent statement details the FDA’s efforts to find ways to reduce EtO emissions and concentrations used to sterilize devices without compromising safety and effectiveness.
August 16, 2022
Fda Logo, Hi Res
Regulatory
FDA Finalizes Instructions for Use Guidance
U.S. Food and Drug Administration
The document clarifies IFU labeling for pharmaceutical manufacturers to help consumers understand complicated instructions when using a drug or biologic.
August 2, 2022
Fda Logo, Hi Res
Regulatory
FDA Releases Draft Guidance on Use of Remote Regulatory Assessments
The guidance covers voluntary and statutorily authorized RRAs, but does not change the core requirements of inspections and pre- and post-market authorities.
July 26, 2022
Fda Logo, Hi Res
Traceability/Serialization
UDI Implementation Highlights Global Challenges
Q&A: At times, the hardest parts of UDI implementation are not about data matrices and linear barcodes at all. Jay Crowley talks global databases, portfolio management, and workforce issues.
July 25, 2022
Some manufacturers continue to use proprietary barcodes for various purposes that existed before UDI along with a UDI barcode. This can confuse downstream users. [Getty]
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