After six years in review, the final emergence of Annex 1 in August 2022 has either been a consolidation of accepted practice and wisdom or a rude awakening for many! However, it is universally accepted that it is decades' most significant single change to regulatory approach. As Annex 1 deals with products made in Europe, or products intended for Europe, it is likely to have a significant...
How to implement an effective methodology to manage data integrity risks based upon process understanding, knowledge of technologies, personnel, and procedures
Cleaning validation can be among the most painful and time-consuming aspects of GMP manufacturing for pharmaceutical developers, but "more complex" does not always mean "more compliant". In this new whitepaper, the Azzur Group's head of Cleaning Validation Services explains best practices for an optimized cleaning validation process and why thorough development, prior to validation, is so...
This article analyzes the hydrogen peroxide deactivation kinetics of representative bioburden in the pharmaceutical, healthcare and food industries, as well as the role of microbial and process variables, such as, type of microorganism (Geobacillus stearothermophilus or Bacillus atrophaeus), temperature, or particle distribution impact over the deactivation process. In addition, the effect of...
Investing in automated, paperless solutions is a logical step in driving laboratory productivity, reducing costs, and enhancing regulatory compliance. Any laboratory manager working with paper-based systems will have experienced the challenges they present, and as laboratories come under increasing pressure to do more with less, the case for digitalization grows. within the wider organization,...
Though tablet compression does not generate large volumes of fugitive dust, safe and efficient collection of whatever dust is created by this process is critical in achieving the widely held goal of “error-free performance.” A tablet press depends on a delicate balance of specified airflow and static pressure, climate control, precise material handling and compression force to run properly....
In many instances, pharmaceutical and chemical manufacturing involves the handling and processing of powder or granular ingredients, many of which have exposure or explosion risks attached when in dust form. A comprehensive risk assessment of each and every application is essential before evaluating the appropriate dust control solution. It is important to choose equipment that is certified to...
Water is one of the most widely used substances in the pharmaceutical industry. It functions as an ingredient, a cleaning agent, a reagent, a solvent and a product, throughout the drug discovery process, from the initial identification of potential drug targets, all the way to the manufacture and quality control of the final product.
We have many solutions for the pharmaceutical industry along with the knowledge and experience to help you address the issues you face with your clean areas. We keep up-to-date on best practices, new design and technology along with the latest trends in the industry.
Properly maintaining and controlling pharmaceutical water systems can be challenging. The design from generation to distribution can result in numerous points of failure that significantly reduce control of a water system. With the demand for production efficiency and push toward continuous manufacturing, utility uptime is critical. At-line or online tools for real time troubleshooting of a...
In this 2-part series, Dr. Catherine Jomary discusses the full process of mRNA Vaccines and Therapeutic manufacturing and the challenges scientists are presented with.
Part 1 of this review will suggest technical remedial options for the production of pDNA. Part 2 of the series will focus on mRNA synthesis, purification, and encapsulation.
At the rate that innovation is coming to the cell and gene therapy space, this is undoubtedly an exciting time for the industry to extend its reach to patients. And, as the technologies become more advanced and transform, regulations are going to evolve and adapt in order to address the biggest risks to the patient. As you look to implement GxP approaches to CGT manufacturing, it's important...