It is not unusual for Pharmaceutical Quality Systems (PQS) to be perceived, as ‘expensive’ and ‘non-value adding,’ by some areas of a GMP organisation. Often managers with Lean or Six Sigma backgrounds struggle to make the correlation between GMP and process efficiencies.
ICH Q10, PQS, is a guidance document first released for industry comment in June 2004, by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
A recent review has reminded me that good business practice and effective pharmaceutical quality systems are closely aligned and a review of ICH Q10 can offer PQS implementers and managers some practical business support.
ICH Q10 is not intended to create new expectations beyond current regulatory requirements (such as PIC/S Guide to Good Manufacturing Practice for Medicinal Products) rather it helps to provide clarification, and is intended to be used alongside regulatory codes.
Whilst ICH Q10 may be optional, it could just be the guidance document you need to help turn the language of GMP into business practices in your organisation.
ICH Q10 facilitates innovation and continual improvement throughout the product life cycle with three key objectives:
- Achieve product realisation that allows the delivery of quality products.
- Establish and maintain a state of control by utilising effective monitoring and control systems for process performance.
- Facilitate continual improvement thereby increasing the ability of systems to fulfill quality needs consistently.
¹ Diagram of the ICH Q10 Pharmaceutical Quality System Model
Knowledge management is a repeated theme throughout ICH Q10. Knowledge management is a systematic approach to collating, analysing, storing and sharing information. The importance of knowledge management is not unique to pharmaceutical industries; your business case to implement an electronic solution to support this process will probably get buy-in from your non-GMP business areas however in ICH Q10 it is closely aligned to quality risk management (QRM) which is a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality (refer to ICH Q9 for more information on QRM) which can only be achieved by routinely evaluating the critical quality attributes of your GMP processes.
In plain business language, we are talking about a reduction in reject numbers and effective and efficient process controls through a thorough understanding of your processes.
These business goals are not unique to pharmaceuticals; analysis of ‘the Toyota Way’ embodied by Kaizen, indicates that continuous improvement and efficient processes with the focus on quality outcomes, is the foundation of good business practice.
Ensuring your organisation has defined management responsibilities, adequate resources to implement, maintain and continually improve your quality systems, as well as provision for employee training, are all requirements of PIC/S, however, ICH Q10 plainly calls for performance indicators as well; a language that your Six Sigma manufacturing managers will easily relate to.
ICH Q10 includes practical guidance on the application of quality processes such as corrective and preventative actions (CAPA) and change management throughout your product lifecycle, helping to clarify the level of control required during development, scale-up, manufacturing through to discontinuation.
The simple guidance tables used throughout ICH 10 will help GMP organisations to establish proportionate quality processes, depending on the different goals of each of your product lifecycle stages.
In summary, if you are responsible for coordinating the implementation and ongoing management of a PQS in your organisation, it may be time to review ICH Q10 for some good, common sense business practice and GMP guidance.
¹ ICH HARMONISED TRIPARTITE GUIDELINE PHARMACEUTICAL QUALITY SYSTEM Q10 Current Step 4 version dated 4 June 2008 – Link