Harmonizing Standards and Specifications

Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-05-02-2002
Volume 26
Issue 5

ICH continues its efforts to establish universal drug development standards and testing as pharmaceutical manufacturers press for additional FDA guidance on specifications.

External Link - article-18595.pdf

Articles in this issue
Direct Compression: Microcrystalline Cellulose Grade 12 versus Classic Grade 102
Harmonizing Standards and Specifications
Polymers in Transdermal Drug Delivery Systems
The Pharmaceutical Development of Inhalation Medicines and the Value of Outsourcing
Expanding the Use of Child-Resistant Packaging
Forced Degradation of Ibuprofen in Bulk Drug and Tablets and Determination of Specificity, Selectivity, and the Stability-Indicating Nature of the USP Ibuprofen Assay Method
Outsourcing Outlook
Analytical Data Management and Archiving: 21 CFR Part 11 Compliance and Beyond
E-Procurement — Reverse Auctions and the Supplier's Perspective
Recent Videos
US tariff rate rising , trade policy , business graph and dollars banknote , tax calculation change | Image Credit: © janews094 - stock.adobe.com
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.
Christian Dunne, director of Global Corporate Business Development at ChargePoint Technology
Behind the Headlines, episode 7
Behind the Headlines episode 6
Related Content
Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS). | Image Credit: © Tada Images - stock.adobe.com

FDA Posts Slate of Seven Warning Letters Following Company Inspections

Patrick Lavery
June 12th 2025
Article

The warning letters deal with a range of violations involving items from personal hygienic products to mismarketed analgesics.

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.

A doctor in a white lab coat shaking hand showing symbol of medicine innovation, treatment, discovery and healthcare analysis. | Image Credit: © chadchai - stock.adobe.com

Geopolitical Shifts Change Nature of Pharma Partnerships

Patrick Lavery
May 28th 2025
Article

The concerns of industry experts expressed at INTERPHEX in April 2025 are still pertinent in an uncertain global political climate.

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 - stock.adobe.com

CHMP Recommends argenx Treatment for Chronic Inflammatory Demyelinating Polyneuropathy

Patrick Lavery
April 28th 2025
Article

The company said that Vyvgart (efgartigimod alfa) is the first novel mechanism of action for CIDP treatment in more than 30 years.

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

FDA Announces New Policy on Advisory Committee Members

Patrick Lavery
April 18th 2025
Article

The policy announced by Commissioner Martin A. Makary, MD, will not preclude employees of regulated companies from presenting their views to committees, and rare exceptions will be allowed.