How Current Good Manufacturing Practices (CGMP) Offer a Reliable Remedy to Poorly Compounded Drugs
While many pharmacists see CGMP as having unduly risen the bar of compliance from what they have been accustomed to under SBOP, proper implementation should not be seen as a regulatory burden when compared to the costs of noncompliance––a point made clear in 2012 when improper compounding at the New England Compounding Pharmacy sparked an outbreak of fungal meningitis which resulted in 64 deaths, hundreds of injuries, and serious criminal charges.
This white paper presents a critical analysis for the importance of CGMP to the safety of compounded drugs.
What you'll find inside:
• Evidence based on FDA activity that in just one year (2016–2017) adoption of some of the basic tenants of CGMP by compounding pharmacies have not been taken seriously or taken hold of as quickly as they should
• Reasons why the absence of elementary practices such as the implementation of a quality management system (QMS), founded on the principal of good documentation practice (GDP), have been cited with continuous and increasing frequency
• Why the crux of the problem of noncompliance to CGMP is the lack of working knowledge of systems comprising CGMP regulations and a lack of basic training on those systems
• How implementation of a quality management system may accelerate the adoption of CGMP as a means of sustainability for compounded medicines in the very near future
Gary E. Ritchie