By Daniel R. Matlis
Yesterday, on the heels of the release of a critical Institute of Medicine Report, the FDA issued a Final Guidance for Industry on a Quality Systems Approach to Pharmaceutical CGMP Regulations. The guidance covers the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM) and the Office of Regulatory Affairs (ORA).
This new guidance appears to be an interim step on the long awaited rewrite of the 1978 GMPs, known as the “GMPs for the 21st Century Initiative”.
According to the FDA, this guidance aims to address the following issues:
A quality system addresses the public and private sectors’ mutual goal of providing a high-quality drug product to patients and prescribers.
- A well-built quality system should reduce the number of (or prevent) recalls, returned or salvaged products, and defective products entering the marketplace.
- It is important that the CGMP regulations are harmonized to the extent possible with other widely used quality management systems, including ISO 9000, non-U.S. pharmaceutical quality management requirements, and FDA’s own medical device quality system regulations. This guidance serves as a first step to highlight common elements between the CGMP regulations and Quality Management Systems. With the globalization of pharmaceutical manufacturing and the increasing prevalence of drug- and biologic-device combination products, the convergence of quality management principles across different regions and among various product types is very desirable.
- The FDA has concluded that modern quality systems, when coupled with manufacturing process and product knowledge and the use of effective risk management practices, can handle many types of changes to facilities, equipment, and processes without the need for prior approval regulatory submissions. Manufacturers with a robust quality system and appropriate process knowledge can implement many types of improvements. In addition, an effective quality system, by lowering the risk of manufacturing problems, may result in shorter and fewer FDA inspections.
- A quality system can provide the necessary framework for implementing quality by design (building in quality from the development phase and throughout a product’s life cycle), continual improvement, and risk management in the drug manufacturing process. A quality system adopted by a manufacturer can be tailored to fit the specific environment, taking into account factors such as scope of operations, complexity of processes, and appropriate use of finite resources.
This announcement is a step in the right direction. However, as stated in every guidance document it “does not create or confer any rights for or on any person and does not operate to bind FDA or the public”.
Let’s see what the “GMPs for the 21st Century” brings.