In 2015, 30 percent of the 40 GMP warning letters issued by the FDA for data integrity deficiencies referenced training issues or requirements.1 There are a number of challenges hindering effective training in life sciences. For example, most companies use one system to manage standard operating procedures (SOPs) and other documents, and a different application…
Supplier Quality: Where Are Pharma Companies Going Wrong?
Novartis Plans to Cut 2,100 Jobs in Switzerland, Britain
Novartis said Tuesday it’s cutting some 2,100 jobs in Switzerland and Britain over several years as the Swiss pharmaceuticals giant tweaks its corporate structure to become more nimble and more efficient. CEO Vas Narasimhan said Novartis hopes to lower its overall headcount worldwide to below 100,000, from about 126,000 today. Much of that is due…
Emergent BioSolutions Expands Manufacturing Capability
ABEC, a global provider of integrated solutions and services for biopharmaceutical manufacturing, will provide CSR dual purpose single-use systems to Emergent BioSolutions for large scale 750L microbial fermentation and 500L mammalian cell culture. The dual purpose systems are custom designed to accommodate Emergent’s process needs and operational requirements and complement Emergent’s 4,000L CSR single-use bioreactor capability. Integration of ABEC’s CSR…
Automation for Preventing Pharmaceutical Recalls
Recalls of pharmaceutical products spiked 52 percent in Q1 2018, the highest since 20131. Though the average recall size has been declining in recent years, due in part to serialization and SKU proliferation, pharmaceutical companies continue to look for automated equipment solutions that can help prevent recalls. Sixty-two percent of pharmaceutical companies predict spending more on…
BASF Expands Vitamin A Plant in Germany
BASF has started the expansion of its vitamin A plant at the company’s Ludwigshafen, Germany site. The new production building expands the existing vitamin A plant, which went into operation in 1970. In total, about 600 machines and devices, 4,000 pipelines and 5,000 measuring points will be integrated into the process control system until the planned…
Takeda Moving U.S. Headquarters From Chicago Area to Boston
Japanese drugmaker Takeda says it is closing its U.S. headquarters in suburban Chicago with about 1,000 employees and moving its functions to the Boston area. Takeda spokeswoman Julia Ellwanger said Tuesday that the work currently performed at the offices in Deerfield, Illinois, will gradually shift to Boston after it completes its $64 billion takeover of…
Emergent BioSolutions Aqcuires Adapt Pharma and its Flagship Product Narcan
Emergent BioSolutions has entered into an agreement to acquire Adapt Pharma and its flagship product Narcan (naloxone HCl) Nasal Spray, the first and only needle-free formulation of naloxone approved by the U.S. FDA and Health Canada, for the emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression. Total…
ICS Opens Third-Party Logistics Pharmaceutical Distribution Center
ICS, a distribution services for pharmaceutical manufacturers and a part of AmerisourceBergen, has opened its newest third-party logistics (3PL) pharmaceutical distribution center in Ohio. The new facility, which will serve as the flagship location for ICS, will further strengthen the company’s already robust end-to-end, integrated solutions for improving access to specialty medication, optimizing supply chain efficiency and…
The Significance of Humidity Control in GMP Compliant Production
Figure 1: Effect of RH% on materials in static locations. It is important to note the relationship between relative humidity (RH%) and air temperature, as variations in temperature also will affect the RH%. For example, a sufficiently large drop in air temperature can result in water vapor condensing out. Alternatively, cold surfaces will cause condensation…