Search results for " PDA" in Articles / App Notes
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
Apr 02, 2015
By Jill Wechsler
Pharmaceutical Technology
Volume 39, Issue 4
To ensure patient access to high quality, safe, and effective medicines, FDA spends considerable time and resou…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.
With the most recent FDA …
Article
FDA Seeks Metrics to Define Drug Quality
To assess contract manufacturers, PDA notes that pharmaceutical and biotech companies use metrics such as supply assurance over the past 10 years, redundant facilities, minimum raw material stocks, an…
Article
Quality by design for biotechnology products—part 1
(For a description of process characterization, see PDA Technical Report No. 42). The refinement of the design space is based on the QTPP and the knowledge gained throughout development. As knowledge …
Article
Bioburden Control in the Biopharmaceutical Industry
Protecting against microbiological contamination over the whole manufacturing process grows increasingly important.
By Mostafa Eissa
The biopharmaceutical industry has witn…
Article
Advancing Single-Use Technology Through Collaboration
…ors in the future, by putting in effort now through groups such as BPOG, ASTM, ASME, BPSA, ISPE, and PDA. I think there’s increased recognition that it’s not ‘us’ and ‘them,’ but it’s a community eff…
Article
Design and Qualification of Single-Use Systems
The author provides a review of the concepts of design and qualification that apply to single-use systems.
By Jerold M. Martin
Single-use technologies (SUT) have made significant inroads in …
Article
Vaccine Development Faces Urgency and Challenges
The design of new antigens based on molecular structure and advances in synthetic biology will help deliver new vaccines to patients, noted GlaxoSmithKline (GSK) Chief Scientist Rino Rappuoli at the P…
Article
GMP Challenges for Advanced Therapy Medicinal Products
Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.
By Sean Milmo
A consultation period…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
This article discusses cleaning validation of equipment dedicated to the production of a single API.
By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chi…