The first issue of 2019 covers some of the regulatory and compendial concerns around glass packaging and the impact on technological advancements in this area.

Debate continues regarding the preuse post-sterilization integrity testing (PUPSIT) requirement in the proposed Annex 1 revision. Find out four ways industry can respond. Also, check out our 2019 PDA Annual Meeting supplement to learn more about this signature event!

What are the top five current concerns around visual inspection? Find out in our cover story! Also, learn how to overcome the challenges of visually inspecting IV bags. Plus, read a summary of the 2018 PDA Manufacturing Intelligence Workshop.

Spring forward with a look at global pharmacopeias! Susanne Keitel, head of EDQM, looks at the future of pharmocopeias and Bei Ma covers regulatory and compendial support for continuous manufacturing. Plus, content on B. cepacia, growth promotion testing and biosimilars!

As more biologics rely on highly potent APIs, how can manufacturers protect both product and operator? This issue’s cover story summarizes two talks on the topic from the 2019 PDA Practical Application of Sterile Manufacturing Workshop. Plus, learn more about what to expect at the 4^th PDA Europe Annual Meeting in our special meeting section.

Isolator technology is becoming increasingly critical to the industry. Past PDA President Jim Akers offers his perspective on isolators. Cipla’s Subrata Chakraborty reviews isolators along with restricted access barrier systems, robotics and single-use technology. Plus, see what you missed at the 2019 PDA Annual Meeting in this issue’s Photostream!

The July/August PDA Letter is now available! The three features explore facets of data integrity from three different perspectives. Plus, check out excerpts from recent PDA publications in the Summer Reading section!

Find out how a multiproduct manufacturer successfully tailored a cleaning validation method for different lines. Learn how an endotoxin testing failure led back to the manufacturing floor. Plus, a perspective on the new ISO water systems standard.

What happens when a Silicon Valley executive with years of experience in that industry enters the biotech space? American Gene Technologies’ CEO Jeffrey Galvin is profiled in this cell and gene therapy-focused issue of the PDA Letter. Plus, read a summary of the 2019 PDA Cell and Gene Therapy Conference.

Find out what some U.S. FDA speakers said about manufacturing innovation and new technologies at the 2019 PDA/FDA Joint Regulatory Conference. Read a summary of sessions highlighting the impact of robotics and big data at the 4th PDA Europe Annual Meeting and a preconference workshop. Plus, check out photos of the 2019 PDA/FDA Joint Regulatory Conference.