IPEC-Americas? Updated Significant Change Guide for Bulk Pharmaceutical Excipients

News
Article
Pharmaceutical TechnologyPharmaceutical Technology-03-02-2005
Volume 29
Issue 3

IPEC-Americas has just completed a major update to its significant change guideline to address current issues in the manufacture of excipient ingredients and to assist manufacturers in developing an impurity profile.

External Link - article-150844.pdf

Articles in this issue
March 2005
Packaging Becomes Part of the Prescription
Appraisal of the Laser Diffraction Particle-Sizing Technique
Optimism Taking Over in Pharmaceutical Chemicals
In the Spotlight - March 2005
IPEC-Americas? Updated Significant Change Guide for Bulk Pharmaceutical Excipients
A “Disclosure Defense” in Liability Law
Managing Aseptic Interventions
Validating Automated Systems
Implications of Photostability on the Manufacturing, Packaging, Storage, and Testing of Formulated Pharmaceutical Products
Combination Products Raise Manufacturing Challenges
Recent Videos
Drug Digest: Strategic Partnerships
Michelle Bridenbaker from Unbiased Science discusses her thoughts on the key industry from 2024 and those she anticipates will impact the industry in 2025 and beyond.
Tore Bergsteiner from MAIN5 details his predictions for how the mega trends will shape the bio/pharma industry in 2025 and beyond.
Related Content
Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Beckman Coulter Life Sciences Launches Modular Spectral Flow Cytometry Module, First of Its Kind in Industry

Feliza Mirasol
March 28th 2025
Article

The CytoFLEX mosaic Spectral Detection Module offers up to 88 channels for detection.

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

Sherwin-Williams to Showcase Next-Gen Coatings for Pharma Cleanrooms at INTERPHEX 2025

Feliza Mirasol
March 28th 2025
Article

Sherwin-Williams’ advanced coating systems are designed to ensure safety, sterility, and efficiency in pharma manufacturing environments.

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

FDA Issues Warning Letter to Aspen Biopharma Labs for API Manufacturing Deviations

Feliza Mirasol
March 27th 2025
Article

In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs.

TOP NEWS on grunge world map | Image Credit: © Sean K - stock.adobe.com

BIO Survey: Tariffs May Reduce Access, Delay Innovation, Create Red Tape

Patrick Lavery
March 27th 2025
Article

The Biotechnology Innovation Organization’s new membership survey said that 90% of US biotech companies rely on imported components for at least half of their FDA-approved products.