So not bad for half-a-year's activity. Let's start at the top of the pile and work our way down.

Quality Management Systems for the Pharmaceutical Industry

The medical device industry has worked either to the US regulations or in Europe to ISO 13489 and these both have a QMS based on ISO 9000. The pharmaceutical industry did not have a similar approach to this just the GMP or Good Laboratory Practice (GLP) regulations, which were written in the 1970's. So the regulatory authorities have attempted to do something about it over the past four years:

1. The US FDA published a 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 constraint by the existing regulations being too vague and were stretched to make the interpretation fit a QMS.

2. The International Conference on Harmonisation (ICH) has written a document in the quality stream called Q10: Pharmaceutical Quality Systems that was published in June 2008.²

ICH is a collaboration between the European, US 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. This approach has produced a far more rounded attempt at implementing a QMS and the advantage is that it does not attempt to interpret existing regulations but places the QMS over the organization like an umbrella. This means that as the QMS is implemented from the top down, and as it impacts existing working practices and interpretation of the regulations it will start to change the way people work and think. Therefore, this will be a structured and gradual rather than big bang approach to quality.

The contents of Q10 cover 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 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 is that quality will be driving a focus on measuring, analysing, understanding and improving the working practices throughout an organization. Typically, this is where little existed in the past. So metrics of how many, how often, how quick tasks take will need to be set up and generated, however, most of these metrics may be based on paper processes and will be generated manually. 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, ICH Q10 will probably be incorporated as an Annex into GMP the regulations. However, there is no published timescale for these activities.