The FDA’s latest effort at transparency in the drug GMP inspection planning process can be found in the new Manual of Policies and Procedures (MAPP) 5014.1, “Understanding CDER’s Risk-Based Site Selection Model,” used to prioritize sites for routine surveillance GMP inspections.
On-site cGMP audits are an important part of creating and maintaining a compliant, reliable, and secure supply chain that safely provides high-quality clinical and commercial drug products when and where needed. An important auditing decision is whether to use an individual or pooled audit.
Learn what U.K. Medicines and Healthcare products Regulatory Agency (MHRA) Senior GMDP (good manufacturing and distribution practices) Inspector Tracy Moore had to say about MHRA’s efforts in the areas of drug/device supply chain security and international efforts on harmonization of data integrity guidance.
Looking forward, the U.S. pharmaceutical industry needs to be aware that despite the FDA’s year-long delay in enforcement, the Drug Supply Chain Security Act (DSCSA, with its specific compliance deadlines, is still law and that it is only draft guidance from the FDA that identifies an intent not to enforce the DSCSA for one year.
The past decades have seen a maturation of the contract manufacturing and development organization (CDMO) business and an increased level of collaboration between pharmaceutical companies and CDMOs. This article explores a number of drivers behind this trend.
When Trevena, Inc. needed to establish a supply chain for its lead compound, OLINVO (oliceridine injection) — a pain-management product expected to make the transition from clinical trial material to full-blown commercial manufacturing — executives at the emerging biopharma decided to try a new framework. Instead of simply relying on decades of collective experience in managing drug supply chains, they augmented that experience with a new set of tools developed by FDA officials and industry professionals under the Xavier University Supply by Design (SbD) Initiative.
According to the latest PharmSource Trend Report, Bio/Pharma CapEx Trends 2016, biopharma companies have invested over $150 billion in new plants and equipment in the past five years. As this sector continues on an upward trend, it is placing significant pressure on the supply chain. Mother Nature in California, Texas, Puerto Rico, Mexico, and Southeast Asia and Amazon’s much-anticipated HQ2 serve as further reminders to plan for mitigating cost and schedule project impact.
Brexit — and the looming fear of it — appeared on a number of pharmaceutical industry recap articles and columns for 2017, as well as ones looking forward into 2018, with many describing it as the most important factor affecting the industry in the next few years. As with all trends, someone will choose to swim against the tide and make the argument against conventional reasoning.
The failure to supply (FtS) provision in a drug product or drug substance supply agreement – typically ranging from a paragraph to a couple of pages – can be the most hard fought over “what if” in the agreement and, after price and volume, the section of an agreement with a high potential to fracture a customer-supplier relationship.
The hurricane season of 2017 will be remembered as one of the worst, with some of the strongest tropical cyclones ever witnessed creating havoc in the Atlantic basin.