International Conference on Harmonisation’s Q10 targets the heart of quality policy
It may come as a surprise to many of you working outside the pharmaceutical industry that there is no formal quality system defined in the regulations. If you work in a laboratory accredited to ISO 17025 (for testing and calibration laboratories), or an organization that works to ISO 9000 or a variant thereof, you will know that the heart of the quality approach is a quality management system (QMS). The essential elements are that quality is driven from the top by senior management — if they are not involved, then everyone is wasting their time. There is a quality policy and, underneath that, the procedures and instructions to enable people to do their jobs and to work together.
The medical device industry has worked either to the US regulations 21 CFR 820 or in Europe to ISO 13489; both of these have QMS based on ISO 9000. The pharmaceutical industry did not have a similar approach to this, relying instead on GMP or GLP regulations written in the 1970s. So, over the past four years, the regulatory authorities have attempted to do something about it.
FDA guidance for pharmaceutical quality systems
The U.S. FDA published the Guidance for Industry entitled Pharmaceutical Quality Systems that attempted to interpret the existing regulations under a QMS banner.1 This is the regulatory equivalent of fitting a square peg into a round hole. The problem was that the existing regulations were too vague and were being stretched to make the interpretation fit a QMS.
ICH Q10: Pharmaceutical quality systems
The International Conference on Harmonisation (ICH) has written a document in the quality stream called Q10: Pharmaceutical Quality Systems that was published as Step 4 in June 2008.2 ICH is the collaboration between the European, U.S. and Japanese regulatory agencies and their regional counterparts in industry, and the aim of the output is to have consistent regulatory approaches on a global basis. Step 4 in the process is the final document before the document is incorporated into the three regions’ regulatory framework. The ICH approach has produced a far more rounded attempt at implementing a QMS for the pharmaceutical industry, with the advantage that it does not attempt to interpret existing regulations, but places the QMS over the organization like an umbrella. As the QMS is implemented, it will impact existing working practices and regulations and will probably be a gradual rather then big bang approach to quality.
ICH Q10 covers the following topics:
• management responsibility, including:
•• management commitment (this is critical to the establishment and maintenance of any QMS)
•• quality policy, quality planning and management review
•• management of outsourced activities and purchased materials (this last subject is very important since the heparin scandal in the US at the end of 2007 and early 2008, which resulted in over 200 deaths from outsourcing production to a Chinese factory)
• continual improvement of product quality and process performance covering the following areas:
•• process performance and product quality monitoring system
•• corrective action and preventive action (CAPA) system
•• change management system
•• management review of process performance and product quality
• continual improvement of the quality system
•• management review of the pharmaceutical quality system
•• monitoring of internal and external factors impacting the pharmaceutical quality system
•• outcomes of management review and monitoring
These are all essential elements of a QMS that have been interpreted for a pharmaceutical company. What it means in practice for the laboratory is that quality will be driving a focus on measuring, analyzing, understanding and improving the working practices therein. Typically, this is where no or few metrics exist now, unless your laboratory has been involved with a six sigma project. So, metrics of how many, how often and how fast laboratory tasks take will need to be established, measured and analyzed. Most of these metrics may be based on paper processes and will be generated manually. However, to be really effective, automated quality systems will need to be introduced.
The next steps in the process for implementing Q10 will be for it to be incorporated into the local regulatory scheme. My understanding is that the FDA will replace their current guidance on pharmaceutical quality systems with Q10 to ensure global harmonization, while in Europe Q10 will probably be incorporated as an annex into GMP regulations. However, there is no published timescale for these activities.
1. FDA Guidance for Industry, Pharmaceutical Quality Systems, 2005
2. International Conference on Harmonisation, Q10: Pharmaceutical Quality Systems, Step 4 document, June 2008; www.ich.org
R.D. McDowall is Principal, McDowall Consulting. He may be contacted at editor@ScientificComputing.com.