March PDA Letter
Free Articles to All PDA Members and Non-Members.
Innovations Offer Solutions for Vaccine Supply Limitations
A variety of factors have caused shortages in the marketplace for vaccines, but outdated manufacturing processes and lack of characterization stand out as some of the most prevalent, if not correctable, factors. Regulators across the globe and manufacturers are searching for ways to stabilize vaccine supplies.
RAQAB Follows Comprehensive Commenting Process
For most of its history, PDA has interacted with global regulators by providing comments to draft publications. Most global health authorities have a process of developing new laws, regulations, guidelines or guidances that require public input. PDA has actively responded on behalf of its members, representing their scientific and technical interests to regulators, and is recognized for preparing scientifically sound comments that focus on issues with the potential to significantly affect the regulatory arena for years to come.
Qualifying Disinfection for Critical Environments and Cleanrooms
Obtaining the highest confidence that aseptic cleanrooms and other critical manufacturing/quality control (QC) environments are properly disinfected is paramount in assuring the production of safe and effective pharmaceutical products or medical devices. The microbiological safety of these products is primarily determined by the quality of raw materials used, the integrity of the manufacturing process, and the effectiveness of the disinfection procedures performed in the facility. It is for this reason that the U.S. FDA requires that manufacturers of pharmaceutical and other critical products qualify the disinfection agents and procedures used in these clean environments.
Read the full March Issue (Members Only)
Follow the 2014 PDA Annual Meeting
logo to read content relating to the meeting. The cover story story features Annual Meeting speakers Jeffrey Weber
and Robert Tomaselli
on the shift to real-time and parametric release. Rahul Singhvi,
another Annual Meeting speaker, discusses innovations in analytical tools for vaccine manufacturers. The Regulation Snapshot outlines PDA’s process for developing regulatory comments.