So, here we are amid a pandemic that the planet hasn’t witnessed the like of for a century!
Not only that, but the planet decided to close itself down in order to fight the scourge.
But did it really? Our own industry was deemed essential, so we have been requested to keep functioning of a fashion, employing creative approaches which in our case involved using remote technology.
Today, many in our field of therapeutics development rely on contract development organizations to develop their processes, make clinical lots and if all goes well, make material for product launch and commercialization. Not only that however, we also employ CRO (contract research organizations), to manage clinical trials and other consulting companies to manage key analytical functions.
So how can we do this under the present circumstances of domestic and international quarantining, and where face-to-face contact is limited.
Clearly, we have been faced with a challenge if we are to keep making progress. Not surprisingly, with technology to the rescue there is/are solution(s) and although it’s not 100% ideal, it does enable a bridge to maintain technology development and quality compliance.
These are topics that should all be part of your business continuity plan, so perhaps this is a timely reminder to keep those up-to-date, practiced and ready to be implemented.
There are so many aspects to business continuity, and we might spend a volume addressing those given the recent Covid 19 disaster, but that really would not be the best use of a blog post which is more to share and stimulate ideas.
So, in the spirits of the collegial collaboration we’ve experienced through Covid 19, here are a few ideas we are employing at SMART Pharmaceutical Consulting, to keep our clients moving forward. We will use a compliance audit to illustrate the principle.
CDMO Supplier GMP Site Audit.
Clearly the possibility of leaving one’s states is currently a nonstarter let alone traveling internationally, because countries demand a 14-day quarantine upon arrival. So how is this to be achieved?
We have approached this using the following methodology:
1. First for the documents review, we’ve arranged for all the documents to be placed into a securable document room operated by a site like Merrill Datasite One. This allows access remotely which is password protected.
With this in place you now have the ability to read any and all documents, make comments and prepare questions.
2. Next, questions can be either emailed to the CDMO company for answers or answered directly by employing a videoconferencing system like business Skype, GoToMeeting or Zoom. We’ve employed all three depending upon the client and it’s worked really well.
3. For the tour of facilities we’ve either postponed that component for the next visit or done a video tour with the site sending a live “face time” type of interaction, with some limited time for questioning. No, it’s not perfect, but it is surprising what you can accomplish under these difficult situations and it’s much more desirable than forgoing the compliance audit schedule completely.
4. Expected benefits. In terms of resources and Lean operations, we may have developed a new operating mode here out of need which will impact practices going forward, post Covid 19 and beyond. The reality is that perhaps these on-site audits can be reduced/cut down to a day if much of the document review can be performed and developed remotely. This will reduce costs for both parties, take less site time for the CDMO staff and enable meaningful interactions to be developed involving time that’s not solely dictated by the actual day at the site. This must be beneficial to improve the quality of the audit and empower flexibility for both parties.