Imagine you are the Quality Director of a site manufacturing critical medicinal products or medical devices. You have a sickness absence rate of 50% of QA and QC staff. The government is keen for the site to produce as much product as possible. You need to develop a plan to keep the site in compliance whilst freeing up resources to help with daily QA/QC activities. Activities can be STOPPED, DELAYED or CONTINUED

STOPPING ACTIVITIES

Stopping an activity may seem to be extreme but with a 50% reduction in staff, actions should be taken proactively before the Quality System slips out of control. An activity that could be stopped is change controls that have not been implemented. As an action, all pending change controls should be reviewed and only those mandatory changes (e.g. linked to regulatory commitments) should be implemented. This will have the effect of reducing validation effort, regulatory affairs work, QC testing and documentation updates. Being extremely stringent with limiting change controlscan free up QA and QC resources. Similarly, any improvement plans such as introducing a new IT system should be halted, again freeing up resources.

DELAYING ACTIVITIES

Delaying compliance activities feels wrong, but in extremes, this can be done using the quality system. Any temporary changes should be made using the quality system.

Quality SystemPotential ChangesControls
Documentation
updates, e.g. SOPs,
test methods
Extend the review period by three
months
> Change control
> Anything linked to a mandatory change, e.g.
pharmacopeial update to be updated in the
appropriate timelines
Self-inspection (SI)
program
Re-plan and move some SIs> Perform a risk assessment on existing plan,
re-schedule lower risk SIs
Annual product
reviews (APRs)
Allow an extra month to complete
the APR Potentially outsource the activity
> Change control
Product complaintsImmediately triage all complaints
Extend the timeline for minor
complaints
> Change control
> Extend timeline for completion of minor
complaints by 15 days
Regulatory
commitments
Wherever possible these should
not be delayed
> If any regulatory commitments may/will not
be met, then the regulatory authority must
be informed promptly

CONTINUING ACTIVITIES

Activities that should be continued in accordance with existing SOPs are those linked to batch release and testing activities. It is important to ensure that there are sufficient QA/QC staff to support production activity and, if necessary, to reduce planned output. If action has been taken to stop some activities at the site and delay others, then perhaps some staff can be re-deployed to bolster frontline staff  Deviations and out-of-specification/trend activities should be performed in a timely manner to ensure product flow and also to identify any problems as early as possible.

In summary, taking a hard look at all activities that consume resources and applying a risk assessment approach can help to free up some resources to bolster direct product fulfilment activities and thereby keep critical medicinal products flowing to patients.

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About The Author

Lynne Byers | VP, NSF International Pharmaceutical Services, EMEA

Ms. Byers has gained more than 35 years’ of extensive pharmaceutical manufacturing management and QA experience working for three major international pharmaceutical manufacturers, culminating in the role of Global Head (VP) of External Supply Operations QA for Novartis in Switzerland. In addition, she worked as Head of Inspectorate and Licensing for the MHRA from 2004-2006. She joined NSF in 2017.

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About NSF

NSF International provides a comprehensive range of support services for the pharmaceutical industry covering consulting and regulatory guidance, training and auditing on a global basis.
We combine experienced industry professionals with former regulatory agency staff (FDA, MHRA, etc) to deliver a unique team that will help you achieve and maintain compliant, future-proof pharmaceutical quality systems.

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