The bioprocessing industry is continuing to invest in training as it seeks to avoid problems and capacity constraints. And while budgets are increasing, new practices such as online components, standardization, and the development of accredited/certified training have not been adopted yet.
The previous article in our “Identifying And Resolving Errors, Defects, And Problems Within Your Organization” series focused on identifying manufacturing trends so you can know when to act. This one discusses what needs to happen when a defect or nonconformance is detected and needs to be investigated, explaining one of the most broadly applicable and durable root cause analysis tools: the fishbone diagram.
The U.K. has until March 29, 2019 to negotiate a deal with the EU to remain a member of the EMA. If no agreement is reached, MHRA has set forth the principles that will be in place on March 30 in case of a “no deal” scenario,including recently introduced new guidelines for the batch testing of medicines entering or leaving the U.K.
The question is no longer, “Will continuous manufacturing work?”, but “When will everyone be doing it?” But surprisingly, there are still many objections to continuous manufacturing within the biopharma industry.
The regenerative medicine sector is at a remarkable moment. Transformative products are now on the market and accessible to greater numbers of patients every day. Dozens of additional therapies are in late stage studies. The regulatory and policy environment has evolved rapidly alongside the science, enabling a surge of incoming innovation.
With the 2018 Compounding Policy Priorities Plan, the FDA has established a clear pathway for advancement of policies for traditional compounding pharmacies and associated outsourcing facilities. The agency intends to implement the strategies while ensuring access to medications for the critical patient population. It is acting under the belief that a growing number of organizations are trying to get into the large drug manufacturers’ domain while operating under pharmacy licenses.
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.
Whether to rotate disinfectants has been debated in the pharmaceutical industry for years. If disinfectants are not used properly, microorganisms may remain on surfaces and proliferate in the environment. This article discusses the concept of disinfectant rotation and the current mainstream industry practice regarding it.
Having a competent, professional workforce is essential to meeting the dual goals of business requirements and regulatory expectations. With a coherent plan and a well-structured learning system that is focused on performance, a pharma firm can efficiently accomplish both.