Remove Communication Remove Compounding Remove Documentation 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. ISPE Good Practice Guide on Containment for Potent Compounds 4.

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. Once the target is identified, researchers work to develop a compound that can interact with it. The need for new medical treatments and drugs has never been greater.

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

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.

article thumbnail

How to choose the right antimicrobial agent for a new pharmaceutical formulation

Pharmaceutical Technology

From alcohols to quaternary ammonium compounds, each type of agent has a unique mode of action, with varying degrees of efficacy. Antimicrobial agents can be used both as active pharmaceutical ingredient (API) and as excipients. Its antimicrobial effect is very well documented in several scientific papers,” says Julien. “It