Promoting Quality in Drug Manufacturing

Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-09-02-2004
Volume 28
Issue 9

FDA is re-engineering the CMC review process for innovator and generic drugs and backing risk-based ICH quality standards.

External Link - article-122719.pdf

Articles in this issue
Excel file and formula for Determining Probability of Passing the USP Content Uniformity Test
In the Spotlight-September 2004
Promoting Quality in Drug Manufacturing
Automation in a Digital, Webbed, and Wireless Age
September 2004
Design of an Aseptic Process Simulation
Use of the Bergum Method and MS Excel to Determine the Probability of Passing the USP Content Uniformity Test
Characterization of the Performance of Bin Blenders-Part 3 of 3: Cohesive Powders
Early Development Still Driving CRO Performance
Particulate-Free Pallets
Recent Videos
Behind the Headlines episode 6
Behind the Headlines episode 5
Related Content
Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Circio and Certest to Collaborate on LNP Formulations

Feliza Mirasol
November 21st 2024
Article

The companies will collaborate to create and test circVec DNA–LNP formulations for use in potential therapeutic applications.

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

CDMO SEKISUI Expands its CGMP Biopharma Manufacturing Capacity

Feliza Mirasol
November 20th 2024
Article

SEKISUI has used a £15.7 million (US$20.7 million) investment to expand its clinical-grade drug substance manufacturing at its UK site.

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

PTC Therapeutics Gains FDA Approval for AADC Deficiency Gene Therapy

Feliza Mirasol
November 19th 2024
Article

FDA's approval of eladocagene exuparvovec-tneq (Kebilidi) makes that product the first FDA-approved gene therapy for treating AADC deficiency.

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Frontier Scientific Solutions Plans a Global Free Trade Zone Gateway to Supply Life Sciences Industry on Back of $1.5 Billion Investment

Feliza Mirasol
November 16th 2024
Article

Frontier Scientific Solutions has unveiled plans to use a $1.5 billion commitment from a major investor to create a global free trade zone gateway to facilitate the life sciences supply chain using Wilmington International Airport in North Carolina.