With the often-tight deadlines to apply for marketing authorisations, Manufacturing and import authorisations and distribution licences to get a molecule to new markets or to expand operations into new GXP areas, it can be tempting to look for an off the shelf quick fix to developing and implementing Pharmaceutical Quality management systems.
In this article, I explore why we should resist the promises of an off the shelf solution or consultants promising that they have templates ready to adapt to your needs. These can often be overly generic and leave serious compliance and operational gaps.

There will, of course, be some basic requirements that will be required in any QMS, such as Management Responsibilities, deviations, CAPA management, Internal Audit, etc. While the requirement to have a QMS is universal across all types of pharmaceutical operations, the detail of what that procedure should contain will rarely be identical. For example, virtual manufacturing and import companies will place a lot more emphasis on vendor management and communication. A classical manufacturing operation will need a wide variety of operational SOPs, for things like line clearance, cleaning procedures and laboratory controls. A distribution operation will need procedures to manage warehouse temperature validation and control and specific GDP procedures such as bonafides and transport management.

The key thing that often gets missed when trying to either get a consultancy or one or two junior Quality Specialists to wave the magic wand and generate a QMS using off-the-shelf templates is that this misses the opportunity to map the processes with all the key management users and providers of inputs/recipients of outputs.

Sitting down with everyone likely to be involved in a new process and fully mapping it out brings a multitude of benefits. For example, once each process map is in place, it makes writing the SOP a lot more straightforward, and there is a visual and easy to understand map there ready to slot into the procedure. Having the process map in the SOP will allow the more practised SOP user to quickly see a high-level overview to keep them on track when using that specific process.

I know that this is the best approach from experience. I worked many years ago for an organisation with several functional teams that worked across different disciplines in a functionally diverse and geographically spread-out organisation. Several failed attempts were made to generate a functioning global change control process, culminating in a CAPA that required us to go back to the drawing board. Luckily this particular CAPA caught the eye of the most senior head of Quality in the organisation.

The decision was taken to pull all the key players offsite and spend several days mapping the best process that all teams could use. I was the new guy in that organisation at the time and had a few years earlier qualified as a six-sigma professional, so I decided, along with another colleague in the team, to co-lead the project and utilise a Kaizen approach to mapping the process and developing the new scalable QMS process.
This resulted in a change control process that was used across the organisation, and which was both transactional and very functional. It was also easy for senior management to dip in and out of and generated meaningful key performance metrics to see how each department was managing their changes and change actions.

So, if you are starting on the new QMS system journey, what things do you need to consider?

The most important thing to consider when starting to develop your new QMS is you need to ask yourself some fundamental questions:
What regulatory standard do you need your QMS to deliver operational compliance?
What Quality Culture do you want our organisation to have (top-down or bottom-up)?
Do you want quality compliance to be policed or embedded in everything you do?
What resources will you have to manage, implement and embed the QMS into everyday operations?

Once, as a senior management team, you have asked these questions and used them to prepare a quality policy, then and only then are you ready to start.  Next, you need to decide who will develop the processes and associated procedures that will form the basis of your quality management system.  It is best to have a small team that will map each of the processes and develop the procedures and it is also important to have the senior management team and key players available.  They will be needed to support that team in short half day or 2-3 hour kaizen type sessions to ensure that everyone on board with the proposed QMS processes.  There should be one overall project manager who has oversight of the QMS development project, and who has a clearly defined plan with milestones and target dates for delivery of the QMS elements.

I have developed complete Quality Management Systems with the associated policies and procedures for many pharmaceutical organisations across my career, from the small virtual wholesaler to the clinical sponsor looking to commercialise their product using a virtual manufacturing model to the commercial manufacturer looking to implement new electronic systems. If you would like to have a chat about your QMS or licensing requirements, please do reach out.

You can contact me at charley@oriongxp.com or by calling us on +353 7198 10101.