In today’s competitive environment it is the objective of all life science manufacturing companies to minimize the risks of compliance non-conformance and the significant associated post-event costs. These costs are seen in human resource non-production time allocations, production delays or halts, and ultimately shut downs and product recalls with potential fines or consent decrees. The ultimate costs will be seen in the potential impacts to patients. These costs can mount into the hundreds of millions of dollars and, as such, should be at the forefront of boardroom discussions.
The total number of Form 483s issued using FDA tools for Drug Inspections in increased again in 2019, reaching 779 for the year. The most frequent inspection observation citation was §211.22(d) “Procedures applicable to the quality unit shall be in writing and shall be followed”. Another observation that increased in a number of citations and that is also related to the laboratory was §211.160(b) “Lab controls should include scientifically sound specifications”. Organizations can avoid these observations for the laboratory with systems that include the procedures for QC lab testing with the according specifications, and that can enforce their execution. With such a procedure execution solution in place organizations can significantly decrease compliance risks.
Learn how technology advances can provide an assured procedural compliance “execution” process that can be applied to any defined workflow. This procedure management system is currently implemented in dozens of operations on a global basis and has demonstrated significant deviation reductions for compliance operations.