Common Compliance Issues on Expiration Dating and Packaging Control
Strict guidelines and regulations have been set up by regulatory bodies such as the U.S. Food and Drug Administration (FDA) to ensure the quality, strength, and safety of pharmaceutical products. These regulations are largely codified in Title 21, Chapter I of the Code of Federal Regulations and administered by the FDA under the Department of […]
Choosing the Right QMS Software for Your Business
Read this guide to find your way through the complicated selection process and choose QMS software that suits both your business and regulatory requirements. Introduction Maintaining quality and conforming with regulations is imperative in life science industry. Ultimately, using QMS software ensures that your company is compliant with policies and regulations, which in turn is […]
Building a Robust Supplier Management Program: Key Strategies for Pharma Companies
Pharmaceutical manufacturing is a sector where the role of supplier management is critical. It directly affects every aspect of product quality, safety and regulatory compliance. To comply with the regulations, pharmaceutical companies must have a strongly defined supplier management process in place that helps to ensure all their suppliers meet the necessary quality standards. The […]
A Comprehensive Guide to Vaccine Stability Testing and Shelf-Life Determination for mRNA Immunotherapy.
Here we walk through the specifics of Vaccine Stability Testing and Shelf-Life Determination, revealing essential strategies and regulatory insights for successful development of mRNA immunotherapies. Vaccine Stability Testing; Why Does it Matter? 1. Preserving Potency The quality and efficacy of mRNA immunotherapies depends on the maintenance of its potency over time. Vaccine Stability Testing assesses […]
Tips for Successful Technology Transfer Between Manufacturing Sites
Technology transfer (Tech Transfer) is a pivotal stage in the pharmaceutical, biotech and medical device industries that ensures the knowledge gap, process handover, guideline differences are met between manufacturing facilities. This fosters innovation, scalability and helps in providing a consistent product which is safe, efficacious and compliant. This comprehensive guide intends to give industry professionals […]
The Vital Role of Quality Audits in the Medical Device Industry
We discuss how quality audits play a critical role in maintaining industry standards and protecting patient safety. In the fast-moving environment of the worldwide medical device market, quality audits play a vital role in ensuring compliance with tough rules. Quality audits represent a reliable connection between producers and regulators making stakeholders more confident, as well […]