Modernizing Pharmaceutical Manufacturing

Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-02-02-2002
Volume 26
Issue 2

FDA's Center for Drug Evaluation and Research is driving efforts toward creating initiatives to streamline regulatory processes, speed up drug production, and reduce costs.

External Link - article-9471.pdf

Articles in this issue
Using Earned-Value Analysis to Better Manage Projects
Microbial Bioburden on Oral Solid Dosage Forms
Overview of Technologies Supporting Security Requirements in 21 CFR Part 11, Part I
Modernizing Pharmaceutical Manufacturing
The Role of Computational Fluid Dynamics in the Pharmaceutical Industry
Available Guidance and Best Practices for Conducting Forced Degradation Studies
Outsourcing Outlook
Effect of Formulation and Process Variables on Matrix Erosion and Drug Release from a Multiunit Erosion Matrix of a Poorly Soluble Drug

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Subscribe Now!
Recent Videos
US tariff rate rising , trade policy , business graph and dollars banknote , tax calculation change | Image Credit: © janews094 - stock.adobe.com
Related Content
Rueil-Malmaison, France - 13 août 2023: Siège social France de Bristol-Myers Squibb, entreprise pharmaceutique américaine née de la fusion entre Bristol-Myers Company et Squibb Corporation | Image Credit: © HJBC - stock.adobe.com

Bristol Myers Squibb Application for Psoriatic Arthritis Drug Accepted for Review in Four Regions

Patrick Lavery
July 22nd 2025
Article

Sotyktu (deucravacitinib) has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.

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.

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

EMA Moves to Secure Supply of Critical Drugs Used During Pregnancy

Susan Haigney
July 10th 2025
Article

The agency’s Executive Steering Group on Shortages and Safety of Medicinal Products has issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins.

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.

Document Review and Quality Control Concept. Document with a checkmark, quality assurance, and process control. auditing, compliance, verification, data inspection, and business workflow management. | Image Credit: © Supatman - stock.adobe.com

A Novel, Enhanced, and Sustainable Approach to Audit Trail Review

Diana Russo
July 4th 2025
Article

Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

Sandoz Recalls Cefazolin Due to Mispackaging, Opens Biosimilar Facility in Slovenia

Susan Haigney
July 2nd 2025
Article

The company is voluntarily recalling one lot of cefazolin for injection, USP, 1 gram per vial due to customer complaints of the wrong product being included in a carton.