So far, 2020 has been a tumultuous year for pharmaceutical manufacturers and distributors and we have no sooner conquered one hurdle or challenge when another one has come our way. Initially there was a rush to put appropriate remote working and social distancing measures in place, and then as new government guidance was published, companies had to decide how and when they would build on these measures such as the introduction of face masks and temperature monitoring once the initial lockdown was over and then moving to more sophisticated measure(s) such as plexiglass screening to improve segregation.
Aside from these safety concerns, we are also assisting our clients with compliance concerns and issues regarding the practical challenges with the full implementation of the Quality Management Systemin a remote working environment, particularly for companies that do not yet have established electronic systems or remote working access to shared folders or drives.
These issues can manifest themselves as higher deviation rates for items such as process variation, delay in CAPA implementation, changed cleaning regimes and general staff shortages or unavailability due to the Covid19 restrictions. The concern in the industry is that these issues may lead to inspection observations thus adding to the resource burden.
Additional changes have occurred in the Quality Culture of organisations where Covid19 has necessitated a shift in responsibility for Quality during production onto the production personnel where the requirement for reduced teams of skeleton staff on site has often moved the QA department to remote working. Quality is now truly everyone’s responsibility and although many organisations have experienced positive improvements in teamwork and shared responsibility, the negative compliance impacts also cannot be ignored.
The main hot topics where we have received feedback from clients include:
- Delays in document approvals and CAPA implementation.
- Additional Deviations to manage Covid-19 challenges and resource constraints.
- Difficulty maintaining appropriate levels of Management oversight due to remote working.
- Issues with Vendor management, access to contract sites and the switch to virtual audits.
- Data integrity, privacy and GDPR concerns as a result of working from home.
- Issues with the cleaning, contamination control and testing programs due to Covid-19 resource constraints.
- The introduction of masks and socially distant work practices in operations.
- The self-Inspection program and its effectiveness in the challenging revised arrangements.
- Remote review by QPs
What is needed now?
It is important that Pharmaceutical manufacturers and distributors reflect on several tough questions regarding what has happened at their sites over the past nine months and whether sufficient care has been taken to ensure continued compliance with the QMS and with the regulatory guidelines. The Covid-19 planning that commenced back in March require constant review as the situation changed and guidance related to changing risks has been ever evolving. Therefore, It may be useful to take a look back over the chronology of events and explore Covid-19 risk management planning in light of all the regulatory expectations that were issued to clarify the responsibilities of manufacturers and distributors during the unprecedented environment of the pandemic and to explore If appropriate measures were taken to not only safeguard public health but also the health of the QMS.
We need to ask if during the Covid19 response and planning, were the risks and the continued compliance with the QMS assessed and were appropriate measures taken to ensure the QMS could continue to operate effectively? In some cases we also need to review how the “new normal” will impact our way of working and what are the steps we need to take to ensure that a move to more remote working is managed in a way that ensures minimal impact on regulatory compliance and product quality.
Also was there a frequent review of the Covid19 plans to ensure they were consistent with the changing situation, guidance from government and the regulatory authority expectations?
What we at Pharmalex can do to support you:
PharmaLex have subject matter experts with in-depth experience who are happy to support your company with assessing the compliance risks in your organisation that may have arisen due to the pandemic.
This support could include:
- Providing expert opinion on the state of compliance of the Quality Management System.
- Providing support with completing Deviation and CAPA actions in your Quality Management System.
- Maintenance of validation programmes.
- Reviewing and completion of your vendor audit program by conducting audits on your behalf.
For more information on this or any other services that PharmaLex provide, why not get in touch by connecting with us on +353 1 846 4742 or email us at contact@pharmalex.com.
