Suppliers audits have become throughout the last fifteen years a pillar component of the pharmaceutical quality system. Today’s GxP compliance cannot be understood without a sound, risk-based policy for supplier qualification, which should include audits as the key step of the qualification process, especially in cases where risks to quality are high or the good or service supplied plays a significant role in the business process.
However, very few, if any, audit policies and strategies have ever foreseen how this essential process can be realised in case of catastrophic events or, as in the current times, in case of a pandemic, when movement of people and social communication is seriously limited.
In front of the fact that most of the audit plans of companies have been almost totally interrupted, the need of performing an audit, either because it is a key step in the clinical phases of development of a new drug or because of regulatory reasons that makes the audit cannot be postponed, is driving the pharmaceutical companies to concoct alternative solutions to cover the regulatory need.
“The need of performing an audit is driving the pharmaceutical companies to concoct alternative solutions”
One of these initiatives is the remote audit. Recently, UK’s MHRA published some ideas on how to overcome the current difficulties for performing regulatory inspections; suggestions include the online review of electronic copies of documents and records, teleconferences and other non-presential activities supported by the available technology.
Changing the mindset on how to plan and design an approach for an audit from a on-site review of facilities, documents and ‘live’ operations to a remote series of activities is not easy. Indeed, the on-site review of some facilities, equipment or operations can be hardly replaced ‘digitally’. However, when rethinking about the real audit experience, one realises that a significant part of the audit time is dedicated to conversations (also translation), explanations and documents and records review. With a careful planning of the agenda, the appropriate preparation of documentation and the wise use of technology, the objectives of the audit can be reasonably covered in a significant extent, at least to fulfil the urgent audit needs.
“A significant part of the audit time is dedicated to conversations, explanations and documents and records review“
Companies can consider carefully when the on-site inspection is irreplaceable, but even in these cases, a large part of the audit can be remotely performed, leaving for better times, hopefully soon, the on-site review of the pending specific key aspects. Many companies started to consider such approach and classifying – based on risks and criticality- and planning remote audits. The deep current crisis can open new opportunities to carry on complying with regulatory requirements and ensuring the quality of medicines.
Dr. Octavi Colomina