With the current COVID-19 pandemic we have on our hands I wanted to take this time to look at how the Life Science industry will be impacted over the coming months.
As an industry we are well rehearsed in healthcare; we spend our lives looking into cures for Cancer, rare diseases, prosthetics for patients and producing products to keep our nation ticking over with their ranging ailments.
It has come to no surprise that as soon as the virus hit, the industry sprung into action putting in the plans, research and testing that they are so used to doing but with a new threat that will have the capacity to touch their lives so personally.
With the industries focus now all turned to a common goal it is unsurprising that everyone is coming together to play their part. From the many retired healthcare workers rejoining the NHS putting themselves at risk, to the vaccine companies looking into ways their research can help provide a solution.
Over the past couple of weeks, we have all had to adapt how we work and Life Sciences is no different.
I caught up with Praveen Beesa QA Director and QP within the Pharmaceutical industry to find out his thoughts on some of the changes within industry:
Spike in Generic products
“This is a challenging situation whereby the majority of the generic bulk products come from India. The lockdown will have an impact on the availability of medicines on the UK market. The short-term solution could be to source from Latin American countries where the lockdown measures are not yet implemented. Other alternatives could be to increase the batch size/production at the UK based manufacturers to keep up with the demand”.
No need for retesting with imported products
“I think this needs to be taken with caution. Annex 16 – in the current exceptional circumstances – could give QPs some flexibility by not having to repeat all quality control tests on importation from a third country manufacturer.
Re-testing on importation should continue whenever possible. Where the QP concludes that completion of certain re-testing prior to batch certification of imported products, will itself lead to delays and supply chain shortage, flexibilities might involve, for example:
Not carrying out product re-testing on importation if the batch has been fully tested in a PIC/S country
Only performing identity and assay for products if manufactured in a non-PIC/S territory, if fully tested to equivalent standards by the third country manufacturer.
This temporary measure shouldn’t increase pressure on QPs as long as the QP has the oversight of the supply chain, access to the Changes/Deviations at the manufacturing plant, sufficient Data Governance procedures and access to the Supplier Audit reports, which all together ensure the effective and working PQS at a supplier’s facility".
Audit Restrictions
“Auditing in the Pharma industry has been a challenge at present due to the travel restrictions we have in place around the world. The Pharma Industry needs to apply the risk management principles to determine the risk of a supplier. Based on the risk assessment, companies can plan out and come up with a risk-based Audit programme.
It can be challenging to secure the Audit dates from the supplier due to staff sickness or increased workload being managed with reduced staff who are working from home. A remote desktop Audit can be a way forward in the interim where a supplier is deemed to be at high risk. The assessment can look into the previous Audit history by Health Authorities, company history, a review of Change controls, deviations and utilities with a tour of facility using a video link, if the supplier agrees”.
Nonetheless, even with these changes to the way we work, it is clear that the industry is pulling together to help defeat the virus.
With a vastly changing economic landscape we have all had to adapt how we work, recruitment being no different. While we appreciate that making your next hire isn’t at the forefront of your working day, it is imperative that the industry continues and that ultimately patients still receive medication and treatments. With the majority of candidates being considered essential workers, it is crucial that as a business we also play our part in helping to support companies in any way we can.
Whether this is helping you to secure top talent to support vital research or being there to support any employees that are unfortunately not needed at this time, we are here and ready to help.
From myself and my colleagues here at Biotalent, We Thank You.
Thank You for the tremendous work you’ve done and continue to do to help us as a nation. I for one am incredibly proud of the UK’s Pharmaceutical industry and although recruitment may be a very small aspect of it, am grateful that I get to play my part.
#weareinthistogether #stayconnected