Inadequate Procedures: A Challenge to the Medical Industry

As global populations increase and people are living longer, more strain is being placed on the life science industry. Complex business models have evolved, and new technologies are implemented to support innovation and sustainability. With the evolving industry, regulations have also been modified, and have become more stringent, increasing focus upon on enforcement and strict regulatory compliance. On this context, life science and medical manufacturers are striving to maintain regulatory compliance, receiving in many cases warning letters, and in other circumstances being subject to facility shutdowns. The purpose of this White Paper is to present the most frequent omissions manufacturers make that may lead to inadequate procedures, which in turn, result in Good Manufacturing Practice (GMP) violations and deficiencies.