Preparing for FDA Inspections: Tips for Pharmaceutical Companies
Navigating FDA inspections? Get the tips pharmaceutical companies need to ace inspections and maintain regulatory compliance.
Requirements of FDA for Training in Pharmaceuticals
The pharmaceutical industry operates in a highly regulated environment where adherence to stringent quality and safety standards is essential to ensure the production of safe, effective, and high-quality products. Among these regulations, the U.S. Food and Drug Administration (FDA) places a significant emphasis on employee training. Comprehensive and well-structured training programs are pivotal for maintaining compliance, reducing errors, and enhancing […]
How to Write Validation Master Plan
Introduction A Validation Master Plan often abbreviated as the VMP provides an extensive description of the principles that are related to the qualification of a particular facility. It defines which systems and areas need validation and provides a comprehensive plan of how to become, and remain, a qualified facility. In other words, the VMP simply translates the validation strategy down […]
Dirty HEPA Filters in Pharmaceutical Industry: The Dangers
Introduction In sphere of medicine the issue of cleanness is rather sensitive for purposing to produce high quality medicines and to minimize the safety risks for workers and customers. There is one indispensable aspect, which helps to maintain cleanliness along with absence of germs in the given environment – utilization of HEPA filters, High-Efficiency Particulate Air. HEPA filters capture particulate […]