Pharmaceutical isolators have revolutionized aseptic manufacturing by offering a controlled, contamination-free environment that enhances both product safety and operator protection.
As the pharmaceutical industry continues to evolve, aseptic processing must keep pace with advancing technologies. The choice between Open RABS, Closed RABS, and Isolators is crucial in ensuring sterility, regulatory compliance, and cost-effectiveness in injectable manufacturing.
The detection of N-nitrosamine impurities in medicines and the increasing presence of nitrosamine drug substance-related impurities (NDSRIs) have presented significant challenges for both drug manufacturers and regulatory agencies.
FDA drug recalls play a critical role in protecting public health by ensuring that unsafe or defective products are removed from the market. Staying ahead of compliance challengesFDA recalls are costly, but proactive compliance measures can significantly reduce the risks.
Learn the fundamental steps and best practices for successful Process Validation in manufacturing, covering design, qualification, and continuous monitoring to ensure product quality and compliance.
Explore the transformative journey of quality assurance in the pharmaceutical industry. From early manual inspections to today’s cutting-edge AI-driven quality control, this article delves into the pivotal moments and technological advancements that have shaped pharma QA, highlighting the commitment to patient safety and innovation.
From research to reality: TerraTrust, the green pregnancy test.
ISO 9001:2015 is the leading standard in quality management worldwide. It certifies to us and our customers that we define all our services and products by a very high standard.
Vaccinations against the SARS-CoV-2 virus are in full swing in all countries. Many people hope for more normality and a way back to old life. So we know that vaccination is the right way, but not everyone is open for this solution. What if a drug treatment of coronavirus disease would also work? We raise the question here and thus
In the course of the last year a multitude of COVID tests have been developed or are in the process of being developed. But, it is the PCR test, for the detection of SARS-CoV-2, that has been the central talking point. The classic PCR test was developed in the 1980s and was a major milestone in laboratory diagnostics. It is
Let’s start by asking the question: What is quality? In simplified terms, quality is the sum and/or the quality of all properties of an object, system or process. The international standard for quality management systems DIN EN ISO 9000 goes a step further and describes quality as: “The capability of a totality of inherent characteristics of a product, a system
In 2017, the European Union (EU) instituted the Medical Device Regulation (MDR) as the next phase in the medical device regulatory framework in order to replace the current Medical Device Directive (MDD). The MDD has been in effect since 1993, and was devised in order to harmonize disparate laws, regulations and requirements pertaining to medical devices. Devices which conform to
