Validating pharmaceutical site layouts is crucial to ensure compliance with regulatory requirements, adherence to industry standards, and creating a user-friendly and efficient environment. Here are…
It’s important for companies to follow the GMP guidelines when manufacturing new products. These guidelines ensure that everything is done cleanly and that every utensil…
In the highly regulated fields of pharmaceuticals, biotechnology, and medical devices, ensuring product quality, safety, and efficacy is of utmost importance. Two key processes that…
The U.S. Food and Drug Administration (FDA) conducts various types of inspections to ensure compliance with regulations governing food, drugs, medical devices, cosmetics, and other…
Process simulation, also referred to as media fill, is an essential component of pharmaceutical manufacturing that assesses a facility’s aseptic processing capability. Regulatory bodies such…
Pharmaceutical manufacturers, nowadays,consider EU GMP as a big step forward for their business. To integrate with the world and bring high-quality medicines to Canadians, Canada…
In the world of modern technology and digital data, compliance with regulations is of paramount importance, especially in industries like pharmaceuticals, biotechnology, and medical devices…
Quality Management System (QMS) is an essential requirement at all drug development and commercialization stages. At different stages, i.e., non-clinical, earlier clinical, to later clinical…
Quality assurance (QA) in pharma is the process of ensuring that pharmaceutical products meet or exceed quality standards. This includes ensuring that the products are…