EMA Lays Out Steps to Combat Production-Related Shortages
The European Medicines Agency (EMA) has outlined more than a dozen short- and medium-term steps to help prevent, mitigate and manage drug shortages caused by manufacturing and GMP compliance problems.
Near-term actions include publishing a standard operating procedure (SOP) for handling reports of shortages caused by quality defects and manufacturing problems, where EU coordination of the assessment is required. The SOP, to be published in the second quarter of 2013, will address the interlinking of regulatory, pharmacovigilance, GMP inspection, assessment and communications aspects of dealing with shortages, according to a reflection paper released Nov. 26.
Manufacturing SOPs are one thing, but how are your trial SOPs? Are they catch-alls, packed with every detail imaginable — everything from what color ink can be used on which documents to where to find the latest informed consent forms? Are they outdated? Are they so long you don’t even know if they’re outdated?
After spending countless hours building out elaborate SOPs, at many sites the result is that no one reads them — or can understand them if they do. The impulse to throw up your hands and walk away from the whole issue is a strong one.
But there’s hope … Streamlining Your SOPs: A Four-Step Guide for Clinical Trials Sites and Sponsors will not only help you tame your SOPs, if you follow its simple principles, your SOPs will never get out of hand again.
There’s no mystery to creating effective and compliant SOPs, but there is a system for it. Streamlining Your SOPs: A Four-Step Guide for Clinical Trials Sites and Sponsors will let you in on the system so your SOPs will never get out of control again.