Robust data integrity begins with both management and employees embracing a quality culture and successful implementation of data governance measures. / read more /
CDER is asking manufacturers to participate in the Experiential Learning Site Visit Program to educate OPQ staff about pharmaceutical manufacturing processes. / read more /
A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing of solid-dosage pharmaceuticals. / read more /
Vendor selection and materials testing are complex enough, but in today's volatile environment, risk mapping and monitoring are also crucial. / read more /
Cart2Core® - Aseptic Cart Transferring System
VAI's Cart2Core®, a patent pending technology, virtually eliminates the problematic issue of correct aseptic cart transference by making the cart top transferable to a new base at each new classification. / Read more /
A three-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects. Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery. / Click here /
Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems.
