From GMP to “EMP”: FDA to Create a Reward System for Manufacturers
(Thursday, May 19, 2022)
When manufacturers of pharmaceutical products rise above the minimum GMP standards, they should be rewarded with fewer FDA audits, higher prices for their products, and strong support from clinical stakeholders, according to a White Paper from FDA this week. FDA believes that such manufacturers will also reduce the likelihood of supply disruptions and shortages. The Good Manufacturing Practices (GMP) regulations establish the minimum quality standards that must be maintained at a facility to be allowed to market its products. FDA assesses formulation, process, and facility quality in applications and monitors and inspects manufacturing facilities to assure quality in drug product batches released to the U.S. market. There is an old joke about GMP that it requires a manufacturer to just be “good enough” and not excellent or best in its quality practices. There is no incentive to spend additional resources for continual process improvements; FDA inspections are reactive, focused on detecting negative outcomes, with no reward for going beyond the minimum requirements. That is about to change. FDA has proposed the concept of Quality Management Maturity (QMM) where a manufacturer implements continual process improvement based on ICH Q10, additional to the minimum GMP requirements described in 21 CFR 210 and 211 and ICH Q7 guidance. Facilities will be rated on matrices such as Process Performance and Product Quality Monitoring System (PPPQMS), Corrective Action and Preventive Action (CAPA), Change Management, Management Review, Quality Planning, and Internal Communication, along with business continuity forecasting, ensuring availability, robust supply chain management, and leadership commitment that incorporates management review and responsibility. The goal of the QMM rating will be to encourage the pharmaceutical manufacturing industry to move toward the six-sigma quality, i.e., no more than 3.4 defects occur per million opportunities. In developing its QMM rating program, FDA will create a standardized QMM assessment tool whereby manufacturers will be rated in a transparent and public fashion. Manufacturers with high QMM rating would not be audited by FDA as frequently as those with lower ratings leading to faster review decisions regarding products manufactured at those facilities. Manufacturer would be able to showcase their QMM scores to the purchasers and stakeholders for competitive advantage. FDA’s stated goal is to foster “a maximally efficient, agile, flexible manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight”. FDA will hold a public meeting next week to collect feedback on the proposed QMM rating program with the stakeholders and plans implement it soon thereafter. We should expect that in the very near future, the “GMP” requirements may be supplemented with a new standard, the “Excellent” Manufacturing Practices or “EMP” to distinguish facilities that maintain a higher QMM score from those that maintain the “mere GMP” standards. Products will likely carry the QMM rating on their labels and marketing material giving a good reason to all manufacturers to aim for the higher standards.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC