Note: The views expressed in this article are those of the author and do not necessarily represent those of the employer, GxP Lifeline, its editor or MasterControl Inc.
In 2002, the Food and Drug Administration (FDA) announced an initiative to integrate quality systems and risk management approaches into existing regulations for pharmaceutical manufacturing. While the FDA hasn't changed the 21 Code of Federal Regulations (CFR) Parts 210 and/or 211 regulations, they have published industry guidance, Quality Systems Approach to Pharmaceutical CGMP Regulations.
In addition, the International Conference for Harmonization (ICH) issued the Q10 Guideline, which describes a model for the implementation of an effective quality management system for the pharmaceutical industry. This guidance integrates key current Good Manufacturing Practice (cGMP) concepts from the pharmaceutical industry with risk management principles, and sets the stage for a systemic approach to pharmaceutical development and manufacturing.
Why should pharmaceutical companies consider implementing a systemic approach to manufacturing and quality? The 21 CFR Parts 210 and 211 regulations provide direction for specific tasks and requirements to manufacture pharmaceutical products. But these regulations do not mandate integration of the activities or documentation of the interrelationship of these key processes to each other.
The Q10 and FDA Guidance recommend you review operations as a fully integrated system. The FDA Guidance states: "Quality should be built into the product, and testing alone cannot be relied on to ensure product quality." Additionally, the FDA Guidance supports the systemic approach to quality for the following reasons:
I know this may seem somewhat daunting, but in reality, the implementation of the systemic approach to quality in the pharmaceutical environment is really just good business. The key to its effectiveness is to keep it simple and not make requirements in the procedures that are unrealistic or overly complicated. Keep in mind a couple of basic business rules:
Following these simple business rules will help you avoid non-conformances and/or observations during inspections. You are probably asking "if the Q10 and the FDA guidance documents aren't regulations and are not actual requirements of law, how can the FDA write 483 observations against the guidance?" In many instances, guidance documents do become defacto law and are considered best practice as investigators issue 483s and warning letters.
It is no wonder that there is a lot of confusion in industry about what to expect from a systematic approach to investigations. In many cases, I have seen companies purchase generic procedures or processes and release them into the system, without understanding the full impact on all phases of business operations. The procedure has included requirements that have not been implemented or embraced by the organization, thus creating nonconformances and/or failures within operations. In other words, the procedure does not reflect actual practice.
Some system procedures are written from the perspective of what someone would like to do, or has interpreted as being required, rather than documenting what is actually being done. This is the biggest issue I see when working with companies that are implementing systems. It is also the primary source of nonconformances and observations from the FDA. When you think about it, integrating tasks and activities with a systemic approach is just good business.
As you start the journey to implementing a systems approach to quality, take time to define an appropriate strategy for your business by considering the following points:
You must have senior management involved and supporting this process from the beginning of the project. Management controls are one of the key elements of a pharmaceutical quality management system. The involvement of senior management, often referred to as management with executive responsibility (MWER) in the development, management, and oversight of the system is critical. Executive management is responsible for the quality of the product produced, as well as compliance to regulations. Without this senior management support, there is little probability of success for the systems approach to quality. Some specific activities to be addressed in this area are:
Note: This is the first of a series of articles published by the author discussing the sections ofthe Q10 and the FDA guidance with simple practical suggestions for implementation within your organization. Each article addresses different quality system sub-systems in relation to the 210/211 regulations and provides some tools that will help you integrate the activities for your business. These additional articles can be found at Pharmaceutical Online.
Christine (Chris) Park is a proven Quality Assurance professional with a wealth of experience in establishing and remediating quality systems of all sizes. As a consultant, she uses a pragmatic approach to compliance and quality assurance. Ms. Park has successfully focused on results-oriented solutions that integrate quality into the daily business activities of organizations. Her experience in R&D and general manufacturing for medical devices, IVDs, and biotech/pharmaceuticals provides a well-balanced background for her work in compliance. She can be contacted at (678) 480-5411 or visit her website at www.qualityarchitech.com.