In order to manage risk in your supply chain, you have to know where it exists. The same logic is applied when quantifying risks during a process change. Just as a lack of quality affects the patient, so does a lack of supply. So what can you do to ensure your supply chain provides a safe and efficient delivery of your product?
In the past, most pharmaceutical companies performed their warehouse and distribution services within their own facilities, with very few outsourcing these processes to third-parties. The supply chain was much simpler then, essentially getting a product from point A to point B.
Sonoco ThermoSafe, a unit of Sonoco and the leading global provider of temperature assurance packaging, has launched the new Certis Silver Universal CRT (controlled room temperature) design-qualified shipper series to ensure ambient thermal protection for pharmaceuticals, biologics, vaccines and other high-value products.
Quality is certainly not new terminology in the pharmaceutical industry. However, I believe it is a term that is sometimes used too loosely within the pharmaceutical time and temperature supply chain. By Jeff Clark, 7P Solutions™, LLC
Integrity testing is a critical operation, especially for sterilizing grade filters used in biopharmaceutical processing. When performed correctly, an integrity test is a fast, definitive, non-destructive way to assure filter retention performance. Fortunately, there are few ways a non-integral filter will pass the integrity test, eliminating the possibility a non-retentive filter is used undetected. Unfortunately, there are a lot of ways an integral filter can fail the integrity test, resulting in retests, lost time, productivity and potentially lost product.
Very few new molecular entities in active clinical development are readily bioavailable, and when dosed at escalated levels, even these may not be sufficiently absorbed. Learn how spray-dried amorphous dispersion might help.
New data from a HTPD comparability case study is shared using three Protein A resins, with key data including yield, purity, DNA & HCP clearance, and Protein A leakage.
The GS1 Healthcare US Secure Supply Chain Task Force, consisting of more than 50 members from throughout the supply chain, has developed a guideline to identify and serialize pharmaceutical products using GS1 identification numbers. The guideline titled “Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes to Support Serialization, Pedigree and Track & Trace” enables pharmaceutical companies to trace the movement of products through the U.S. pharmaceutical supply chain.