The US regulator has published the guidance in a document titled "Quality Systems Approaches to Pharmaceutical Current Good Manufacturing Practice (cGMP) Regulations" in order to help manufacturers maintain consistent high quality and improve efficiency.
Following its Critical Path initiative which seeks to modernise the development of new drugs, the FDA believes the new guidance will demonstrate to the industry the benefits of incorporating modern quality principles, fostering technical advancements into manufacturing processes to better ensure the safety and efficacy of drugs.
The aim also is to help produce drugs more efficiently, which should help lower costs and prevent shortages of critical medicines due to manufacturing failures that can result in product seizures and recalls.
However, the document is not intended to create new requirements for pharmaceutical manufacturing that go beyond those established in the current regulations, nor is the guidance intended to be a guide for the conduct of FDA inspections.
Rather, the guidance explains how implementing comprehensive quality systems can help manufacturers achieve compliance.
Indeed, the inherent flexibility of the cGMP regulations should enable manufacturers to implement a quality system in a form that is appropriate for their specific operations, the FDA claims.
What is more, with the globalisation 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 becoming more and more desirable.
Therefore, the guidance serves as a bridge between cGMP regulations and other quality management systems such as ISO 9000, non-US pharmaceutical quality management requirements and the FDA's own medical device quality system regulations.
When coupled with manufacturing process and product knowledge and the use of effective risk management practices, the FDA has concluded that modern quality systems can handle many types of changes to facilities, equipment and processes without the need for prior approval regulatory submissions.
Consequently, manufacturers with a robust quality system and appropriate process knowledge can implement many types of improvements.
By lowering the risk of manufacturing problems, an effective quality system may even result in shorter and fewer FDA inspections, according to the agency.
Furthermore, a quality system can provide the necessary framework for implementing quality by design, continual improvement and risk management in the drug manufacturing process.
Thus, a quality system adopted by a manufacturer can be tailored to fit a specific environment, taking into account factors such as scope of operations, complexity of processes, and appropriate use of finite resources.
The full text of the guidance is available online >here.