April PDA Letter

Our April podcast is now available! Listen to Vetter’s Joachim del Boca discuss his role as a Qualified Person for a CMO.

Our previous podcasts featured Katja Kotter, Martin VanTrieste, Mark Sebree, Cathy Burgess, three U.S. FDA officials, and a recording from the closing plenary of the 2013 PDA Pharmaceutical Quality Metrics Conference.

Free Articles to All PDA Members and Non-Members.

USP Looks at Future of Microbiology With New Standards
From a microbiological perspective, pharmaceutical products fall into two categories, nonsterile and sterile. For either category, manufacturers must eliminate or minimize potential health risks to patients related to microorganisms and the toxins they produce, while also maintaining product quality. Many contributing factors may affect the quality of a medicine or its ingredients, but microbial bioburden control and proper sterilization methods are critical considerations for the manufacturer throughout the product’s lifecycle.
Preventing and Managing Drug Shortages
Medical and pharmaceutical science has made incredible advances in providing therapies to patients that are transforming quality of life and survival. As a pharmaceutical company, delivering safe, efficacious quality products to patients has always been, and continues to be paramount and what we must strive for. Unfortunately, “drug shortages” have increased in frequency and severity since the early 2000s for many reasons. Though the drivers in Europe and the United States are somewhat different, data suggests that approximately 40–50% of shortages are due to manufacturing quality issues.
Parenteral Packaging Concerns for Biologics
Bringing a new biological drug to market requires a huge financial commitment and entails risks in every stage of the development process. The risks associated with selecting the appropriate component for packaging the drug may not be at the forefront of early stage thinking, but are real nonetheless and can have a profound impact on the drug product. Packaging components must meet functional requirements to ensure safety at the point of administration and protect the purity of the packaged drug product for its shelf-life, usually a minimum of two years.
Read the full April Issue (Members Only)
The PDA Letter looks at pharmacopoeial updates in this issue. Radhakrishna Tirumalai of USP outlines recent changes to microbiology-related standards in the United States while this issue’s infographic explores the structure of the pharmacopoeias in Europe. Ursula Busse, Stephan Roenninger and George Roessling summarize PDA Europe’s January QbD workshop. Plus, find out what topics were discussed at last year’s Annual Meeting for PDA’s Japan Chapter.