Restricted Access Barrier Systems (RABS) have emerged as a cutting-edge technology to address challenges, providing a robust solution for aseptic processing in pharmaceutical and biotechnology industries. In this article, we will delve into what RABS technologies are and explore the steps involved in their successful implementation.
Validation by design thinking in the pharmaceutical industry, often referred to as “Validation 4.0”, is a shift in approach that adapts to the evolution of the industry.
Definition Validation Master Plan is an approved written plan of objectives and actions stating how and when a company will achieve compliance with the GMP requirements regarding validation. It is a document which defines the intentions and the methods that are related with validation of facilities, utilities, system, equipment, instruments, materials, analytical methods, It Systems, cleaning procedures
What is Cybersecurity? According to The National Institute of Standards and Technology (NIST) of the U.S. Department of Commerce, Cybersecurity is the process of protecting information by preventing, detecting, and responding to attacks. In other words, Cybersecurity is a set of actions taken by Companies, stakeholders and or other third-parties to reduce risk to systems
I was asked one day to explain and to describe my professional job. Based on my educations, my skills and job experiences, I used to deal with quality and Good Manufacturing Practices (GMP) principles in Biopharmaceuticals, Foods, and cosmetics. I finally considered to qualified myself to improve human being by collaborating to deliver a quality