Traditionally, most pharmaceutical companies have preferred to conduct on-site audits of their vendor partners. Seeing the partner’s facility in person and meeting the people who will be handling your product has been the ideal method of observation. However, the COVID pandemic has brought about a paradigm shift in the way things are perceived and done. Today, meeting new people face to face is not considered safe by most because of the widespread reach of the virus and its ease of transmission. As a result of travel restrictions imposed by various governments and general apprehension about the COVID-19 disease, people are innovating new ways to work effectively. Hence, pharmaceutical companies are extensively adopting remote audits to meet the requirement of auditing a manufacturing facility.
How are pharma companies adapting to this new normal?
Some companies are definitely hoping to bounce back to the pre-COVID ways of working, but timelines for this remain unknown. Others are exploring new avenues and opportunities to work remotely with customers. To expedite activity, Contract Development and Manufacturing Organizations (CDMOs) have directed their efforts towards offering customers the option to conduct remote audits.
The three main aspects of on-site audits that customers should experience in remote audits are:
- Review of relevant documents
- Interviews with staff
- Tour of the facility
Document review:
Surprisingly, reviewing documents and records virtually can be more efficient than doing it on-site when the right measures are taken. With the increasing number of online data theft cases, the main challenge is to ensure that the confidentiality of intellectual property is not compromised. Hence, choosing the right tool, technology and approach become crucial. A secure data room can be created for customers to access documents to their satisfaction. Restrictions in place can prevent the auditor from printing or saving the document.
Staff interviews:
Today, with the assistance of virtual meeting technology, it is possible to create an online inspection room where interviews with key staff members can be conducted remotely using web conferencing tools. In fact, during the pandemic, this technology has grown by leaps and bounds and has become a way of life for most companies.
Site tours:
Conducting virtual tours may appear to be a daunting task. However, with the assistance of well-equipped cameras and strong bandwidth, live online tours can become an efficient way of introducing a customer to the intricacies of a site. Walking robots can also be an option when you are not operating in a GMP environment. These tours can be accessed anywhere there is internet access, including the comfort of the armchair in your living room.
Regulatory inspection and approvals:
By setting up a system that is nearly equivalent to on-site inspections, regulators will have a high degree of confidence and assurance on the quality systems of the site. Document reviews can be done offline, giving additional flexibility to the auditors. Using the search option, auditors will have the ability to easily check the compliance of the document.
Even in the post-pandemic world, remote audits have great potential to become the preferred option. This medium has various other benefits such as saving costs for the company, reducing hassles of travel, avoiding time-zone differences and circumventing the effects of harsh weather.
John Athayde
Head – Quality
Piramal Pharma Solutions (India)
Monika Bornani
General Manager – Corporate Quality
Piramal Pharma Solutions
