posts tagged with Pharmaceutical

Risky Business

FTB-risk.jpg
This year the Food and Drug Administration (FDA) issued a report titled “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach” (cGMP stands for Current Good Manufacturing Practices). The Medicines and Healthcare products Regulatory Agency (MHRA), the equivalent of the FDA in the United Kingdom, has long adopted a risk-based inspection strategy. A risk corresponds to the possibility that a function, a procedure or a product does not perform as expected. Risk management programs consist of activities and actions to control risks. References on risk management for the healthcare industry are widely available...

FedEx Qualified!

direction1.jpg.jpeg Healthcare shippers, including pharmaceutical, biotechnological, medical device, equipment and diagnostics companies carefully select their transportation providers. Obviously, pricing, reputation, reliability, expertise and infrastructure have always played an important role in selection decisions.

In the last couple of years, however, many healthcare companies have established tighter internal procedures for assessing their vendors, including suppliers of services. Among quality professionals this assessment is known as “qualifying vendors”. Despite continued restructuring efforts in the healthcare industry, quality departments across the United States have experienced rapid growth due to the increasing importance of quality issues.

Spoiler Alert: Temperature-sensitive Healthcare Shipments in Transit

shot4.jpg
Whenever a shipment is transported in a complex network involving many transportation modes, outside temperatures cannot always be well controlled. The shipment is exposed to various climatic conditions on tarmacs and on loading docks. Temperature excursions affecting the quality and potentially spoiling temperature-sensitive healthcare products are a major concern.

FedEx Express Establishes Default Temperature Settings on the B777F

PictureB777F-b.jpg ...FedEx Express has implemented procedures to maintain temperatures on board its new B777 aircraft remain within the CRT range during flights.

Extensive research studies were conducted by FedEx to determine the appropriate default temperature settings, so now cold chain shippers can plan accordingly with a great degree of confidence regarding what the temperature ranges will be in flight...

Cold Chain for Beginners

laot-blog-image.jpg Cold Chain is a term used to characterize temperature-controlled storage, distribution and transportation. The term can be misleading since it does not refer to “cold” temperatures in particular. Products that are sensitive to temperature variations, whether they be perishables such as fruits and vegetables or more sophisticated drugs and medical devices, are included in the term “cold chain”. However, cold chain is often more narrowly used in reference to temperature and time-sensitive high value healthcare products...