my main reason for taking the course was to re-evaluate quality agreements and how to improve our current template. coming out of this, i would like to compare a few of our supplier quality agreements against the structure and checklist given in the course to see how they align. i took the course to get a better understanding of fda requirements. as an iso 9001 registered organization, we need to control and cooperate with suppliers and this gave me some ideas on more formal ways to do that.
in the first part of this two-part article, we looked at how dependent the u.s. pharmaceutical supply chain is on critical ingredients produced in china and india and the risk that could pose to the nation’s drug supply. process validation has been at the center of attention of regulators and parenteral industry practitioners for years — more than 40 years to be exact. there are gaps in our country’s collective knowledge required to determine the severity of the current pandemic’s risk to our supply chain for drugs. undoubtedly, these gaps will remain, leaving questions that need to be answered and will, hopefully, serve as a road map for legislators and advocates of the industry. this article examines five common mistakes you’ll want to avoid when dealing with oee.
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