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Visible Particulate FDA Recall Notices by year as compiled by John Shabushnig, Insight Pharma Consulting, from FDA data. Reprinted with permission.

Particles in Parenterals: 2019 Update

FDA expects a visual inspection program and parenteral manufacturers should expect questions about their program during any inspection. What's new in 2019?

Hal Baseman, Chief Operations Officer at ValSource, LLC and Richard Johnson, President & CEO of PDA at the 2017 PDA Annual Meeting

PDA Becomes an ANSI Accredited Standards Developer

PDA Annual Meeting: Established success in developing technical reports leads organization to pursue standards development in pharma and biopharma manufacturing.

A regularly updated library of consensus-based classifications of defects by pharmaceutical manufacturers and suppliers would help reach conformance specifications and allow for organizations to better meet regulatory expectations.

Defect Classification: Is Harmonization Possible?

As product quality regulations become increasingly stringent, achieving uniform and quality-based criteria for classification of defects will become a collaborative effort among stakeholders.

Current potential for blueprint acceptance across the EU.

The EMVO’s centralized approach to meeting the Falsified Medicines Directive

With the 2019 EU-FMD deadline looming, this non-profit has created a centralized hub for manufacturers and countries to connect to in the effort to streamline verification of medicinal products in Europe.

With many locations, service providers, cross-docks and interfaces, the road transportation supply chain can be extremely complex. Image courtesy of Achim Bundschuh and PDA.

GDP-Compliance Challenges in Road Transportation

An expert’s review of audit findings from 2013 to 2016 sheds light on where supply chain improvements have been made, and where the industry still has room to improve.

Should the industry take a step back, and question the frequency of audits?

Future Industry Considerations From PDA Europe’s Cold & Supply Chain Logistics Event

PDA’s Amsterdam conference highlighted efforts concerning the Falsified Medicines Directive, controlled temperature transportation and new GDP requirements.

Amsterdam is the site for PDA Europe's Pharmaceutical Cold & Supply CHain Logistics conference.

Watch for ‘smart coolers’ for patients

TR 72— Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance—now available for download.

Amsterdam is the site for PDA Europe's Pharmaceutical Cold & Supply CHain Logistics conference.

LIVE FROM PDA EUROPE: Watch for ‘smart coolers’ for patients

TR 72— Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance—now available for download.