Marta Kalas explains how to develop a COVID Safety Toolkit to ensure pharmaceutical businesses comply with changing regulations.
The pharmaceutical industry is well aware that COVID-19 will be with us for some time. In light of this, every business needs to create processes and systems to ensure they operate safely, without being overburdened.
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.
What you’ll discover:
Key trends shaping the pharmaceutical formulation sector
Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
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One way to achieve this is to create a COVID Safety Toolkit – a package of tools to help you keep track of the changes and ever-increasing regulation and any actions you need to comply with. Although creating a toolkit may sound overwhelming, the good news is that none of these activities are new. The difference is that each action requires a COVID-specific version.
What is a Toolkit?
Rather than creating individual processes and numerous standalone documents, a toolkit brings together every item required to respond to COVID-19 in one place. For example, the text you use on your customer displays can also be used on your website, in work manuals or compliance documents. COVID-19 affects all parts of a business and the requirements to respond to the virus can change rapidly. Imagine if you had to check and update them all, one at a time. The chances of missing one or keeping out of date information is quite high. That is where a toolkit can help and why it is important to have one.
What should a Toolkit contain?
1. Governance framework
You need to decide who is in charge. Who has oversight of all your COVID-19 related activities? Now that we are a year into the pandemic, this has probably already been completed, so put it into your COVID Policy to ensure that everyone is informed.
2. Risk management (including individual and group risk assessments)
This comprises all the changes, adaptations and new ways of working you have put in place in response to COVID-19, which hopefully should not need to be changed. If these are risk assessment-based and clearly documented (a simple Excel sheet will do, the key is clarity, not length), you can quickly check what needs updating if there is a local or national amendment to guidelines. Most of your arrangements can probably stay as they are, but do you know which ones need to change and how? If your original assessment is at hand, in an easy-to-access document, it can be revised very quickly. You may need to assess an individual person’s risks as well. For example, somebody who has recently had COVID-19 will need different support than someone who has never been infected or someone who lives with an elderly relative. Our general understanding of risks relating to specific groups (young people, healthcare workers, etc) is much better than earlier in the year and is constantly improving. You may want to fine-tune your risk groups at regular intervals. Again, this is where having a central document will save you time.
3. Action plans
This goes hand-in-hand with your risk assessment changes. If there has been no change then no action is needed. If there has been a specific change in risk, you will need to change the mitigation that helps reduce that risk. If you do this by modules or sections for each area of your pharmaceutical business, each building or physical space, you will be able to initiate changes much faster and you can also check that nothing has been missed.
4. Communications plans
This is where COVID-specific planning pays a lot of dividends. It is worth dedicating time to this as it is the area that is likely to change most often. Here are the key points to consider:
understand your audience
listen to them actively
be clear about what you want to say and say it simply
use the appropriate channel(s)
make sure your communication is timely.
You also need to use trusted sources of information. There is so much conflicting, confusing or out of date information circulating, so it is always best to check the government websites first.
In the UK, these would be the following (though every country will have their own government resources):
You can utilise templates to save time and keep communication consistent across channels. Ensure that anyone involved in any form of communication (from PR to social media, from web editor to marketing flyers, from poster designs to advertising) knows what your COVID-19 messaging is as well as when and how to include it in their channels.
5. Review and update plan
For this, you simply need to check repeatedly and at regular intervals what the current regulations are and what you and your workforce are required to do. You will also need to have evidence that you are properly carrying out your duties as an employer.
Tools to help you
Fortunately, there are some tricks and tips you can use and in COVID-19-related activities, they are essential:
in electronic communications (websites, newsletters, chats, etc) use links directly to the relevant government websites (see list above)
use shared file systems (eg, Google Drive, One Drive or Dropbox) for templates and drafts
keep a log of where these templates are located and where they are used, to make sure you do not miss one
it takes an extra few minutes to get everything in one place when you start, but it will pay dividends many times over when you suddenly need to make a change.
Once you have the Toolkit in place, you will know what needs updating, how and where to make it happen when the government announces a change or you get notified by your local public health representative.
About the author
Marta Kalas is Co-Founder of Thomson Screening, developers of the Thomson Covid-19 Test Manager software platform that enables testing providers to scale irrespective of where, how and what test is carried out.
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