OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part V)
In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights throughout the years. Parts I, II, III, and IV focused on Hatch-Waxman, medical privacy laws, FDA’s user fees, and prescription drug traceability. Today’s blog looks back at changes in drug GMPs over time.
After the Second World War, a group of young veterans developed a method to mix, process, and package bovine intestines in a manner that allowed surgeons to pack organs and stop bleeding. The product, developed under a $1,500 government grant, proved useful beyond the veterans’ imagination. From battlefield surgery to bloody noses sustained on college and playground football fields, the specific surface area configuration or form of the product stopped the blood from cuts and contusions.
When the veterans retired in the 1970’s, fading into the collective memories of history, this revolutionary medical advance almost faded with them. Why? How could an important medical product simply fade away with the inventors’ lives? The art of making the product could not be replicated by the scientists and engineers who followed. The inventors knew how to make the product, but the process had never been reduced to a verifiable and repeatable procedure.
Good Manufacturing Practices (“GMPs”) were developed in other industries prior to the FDA requiring their use in safe production of medical products. The automotive, aviation, defense, and multiple other manufacturing industries all used GMP’s rigorous procedures with quality systems to assure their products performed as intended, according to specifications, 100% of the time.
To achieve this goal, manufacturing processes are “design-reviewed,” meaning they are formulated with subject matter expert and operational implementation personnel input, to maximize efficiencies in achieving product specification goals. All materials and equipment are pre-qualified prior to their introduction into the assembly or service process, and point-of-process completion quality systems assure the product meets specifications prior to completion.
Medical products, both drugs and devices, did not initially require GMP production documentation, with the resultant failure to meet expected performance.
The well documented, inadvertent contamination of sulfa drugs with phenobarbital in 1941 (resulting in approximately 300 patient deaths), and failure to totally inactivate polio viruses in one vaccine batch in 1955 (resulting in approximately 60 inoculated patients developing the disease), led to the establishment of Federal GMPs Regulations for drugs (21 CFR Parts 210 and 211) and medical devices (21 CFR 820). In 1978, GMPs developed into the most rigorous of Good Manufacturing Practices.
The meticulous design-reviewed processes are only effective because they are required to be conducted under point-of-process completion quality systems by the entity utilizing the process, to assure the processes are completed as intended. Pre-qualification/validation of raw materials and required services before either are entered into the process, with review of the data at the time is acquired, provide control over the outcome quality.
*Certain parts of this blog were adapted from a Policy Forum article written by Neil DiSpirito and Anton Usala.