Remove Communication Remove Documentation Remove Dosage Remove Pharmaceutical Companies
article thumbnail

New Trends & Requirements from Digitalization, Annex 1, Continuous Manufacturing & High Potent Manufacturing

ISPE

The document provides specific guidance on the sampling and testing procedures for environmental monitoring, as well as the limits for particular and microbial contamination. Automated systems offer a range of options for pharmaceutical companies. Environmental monitoring is another important aspect of Annex 1.

article thumbnail

How using AI in clinical trials accelerates drug development

Pharmaceutical Technology

But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. For example, important information may be locked in knowledge silos or gained through experience, making it difficult to find or document.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Pharmaceutical Procurement Strategies Overview

Viseven

Hidden expenses can pile up, spiraling out of control due to many reasons related to supplier performance: the lack of appropriate documentation, storage, wrong dosage forms, and the list goes on. Technologies allow pharmaceutical companies to collect and analyze a massive amount of data to ensure proper drug safety.

article thumbnail

Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing

ISPE

For example, one pharmaceutical company that switched to CM reported a 50% reduction in operating costs, a 33% reduction in waste, an 80% reduction in manufacturing and testing cycle time, and a 66% reduction in time from testing to release. End-to-end continuous processes flow from starting materials to finished dosage forms.

FDA 52
article thumbnail

CMC Requirements for New Drug Registration in Latin America

ISPE

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.