Thibeault, Abuta (1991, ASQC) Anita Thibeault & Associates, Huntington Beach, CA
The Good Manufacturing Practice (GMP) regulations issued by the FDA in 1978 contain regulations for the manufacturing of drug products. The FDA's goal was to prevent defective products from being shipped to customers. However, the pharmaceutical industry felt that the regulations were too restrictive and did not permit innovation in manufacturing processes and also made it difficult for them to compete with foreign companies.
This article describes a series of hearings where the FDA presented their case against a pacemaker company. Although the case did not result in a solid victory for the FDA, it did set a precedent that affected the FDA's future approach to implementation of Good Manufacturing Practice (GMP) regulations. The case also had a dramatic impact on the medical device industry's principles of quality assurance.
As a result of the GMP regulations, the industry experienced a reduction in product defects, malfunctions and recalls. However, after several years of GMP implementation, there was an increase in the number of recalls being issued. The FDA then implemented a computerized data base to perform trend analysis, and their conclusions led to the control of manufacturing processes known as process validation.
In 1990, the FDA applied Total Quality Management (TQM) concepts in their proposal to revise the GMP regulations. Although the cost of compliance increased the cost of doing business, the changes in concepts and approaches have had a positive effect on the industry.
Food and Drug Administration (FDA),Good Manufacturing Practice (GMP),Validation,Quality assurance (QA),Total Quality Management (TQM),Trends,Defects