Hybrid and virtual work models are becoming the normality, so how does the pharma industry decide what is appropriate for the QP in manufacturing and virtual manufacturing/wholesaling operations?
With the new rules from the HPRA allowing remote certification in certain circumstances and the Q&A being drafted at the European level by the GMP / GDP Inspectors Working Group, we thought we would take a closer look at the options available for the QP currently in the Pharmaceutical industry.
The GMP manufacturing space is unique as often work needs to be completed onsite either in the pilot plant, testing laboratory or close up to major equipment and utilities where decisions need to be made in real-time. In the past, before remote work was a possibility, the QP had to live within easy commuting distance of the manufacturing or import site and have an in-plant presence every day. This, of course, had the knock-on effect of making it difficult for the head of quality to recruit. These days however immersive technology puts us closer to the manufacturing space than ever before. There will also be days where reports need to be drafted, procedures to review, online training completed, and meetings attended where a virtual presence is entirely appropriate.
I have had the conversation around the appropriateness of some level of remote work with senior quality directors many times over the past decade, from the point when bandwidth and VPN technology made virtual work possible right up to now. This conversation has evolved over time and has been really focused in the past few years when pharmaceutical professionals, including the QP, were forced to work remotely. However, hybrid and virtual work model will be around for the foreseeable future, and there are a few key takeaways that will continue into the post-pandemic pharmaceutical workplace.
The most effective quality directors will allow the decisions on whether an in-plant presence is required to be left to the incumbent to assess what is sensible based on business needs and their own work/life balance. The most successful companies will be flexible and allow quality departments and teams to build their own balance without imposing rules and policies. Rather, they will foster a trust-based culture and make it more about getting the optimum in efficiency and compliance.
Being a QP can be a hybrid role, but rarely can it ever be a fully remote position. Even for pharmaceutical companies that utilise an entirely virtual manufacturing model, it is imperative that the QP has detailed knowledge of the steps for which they are taking responsibility. The QPs must be able to demonstrate their continuous training regarding the product type, production processes, technical advances and changes to GMP. This would never be possible in a fully remote environment, and for virtual manufacturers, the means of ensuring continued approval of a CMO site is particularly important. Whether this is maintaining a person on-site or ensuring that they take an active in-person role in the periodic routine site audit as QP. For either approach, it is essential to ensure the site is compliant with GMP and is capable of manufacturing the products in compliance with GMP and the marketing authorisation.
So, in summary, for a pharma company to succeed, it is critical to ensure that the right balance of on-site, remote and hybrid models caters to the business needs and that every function and role within the business strikes the right balance. For the QP, it should always be about maximising working knowledge of the manufacturing process and the products they release while maintaining their work-life balance.
At Orion GXP Consulting, we understand this delicate balance.
We have decades of experience in building a bank of working product and process knowledge so that the best use can then be made of flexible working arrangements. We have also successfully applied for and obtained remote QP release capability on several MIA licences for our clients in the last few months.
If this is something you would like to discuss further, we would be delighted to talk; please get in touch by emailing charley@oriongxp.com or calling +353 7198 10101.