Almac Clinical Services has digitised its conventional on-site auditing process and launched a virtual auditing solution for clients. This is to ensure continued quality and regulatory compliance during the current COVID-19 pandemic, maintain GMP standards and deliver on the terms of quality and technical agreements all whilst protecting employees and upholding social corporate responsibility to partners and suppliers. Global clients can realise clear advantages, saving time and money otherwise spent on travel and accommodation requirements.
Within the clinical supply industry, there is a significant emphasis on robust supply chain processes. Audits are essential and play a critical role in ensuring clients can continue to deliver and meet regulatory standards. With continued advances in technologies available for business communication and as a direct response to travel restrictions and social distancing measures posed by the current pandemic, postponing audits is not a long-term option. Almac is, therefore, offering a series of alternative auditing strategies for its clients, enabling them to facilitate ongoing clinical trials and accelerate timelines for COVID-19 studies.
“With a changing clinical trial landscape and the need for an adaptable business model due to impacts of COVID-19, Almac continues to innovate and provide solutions for clients,” said Dr Robert Dunlop, Managing Director & President, Almac Clinical Services. “Our clients are supporting complex, global clinical studies, and we understand the pressures they face at this time. In fulfilling our obligation to ensure quality oversight, it is important Almac continues to provide an environment where traditional systems and procedures can be suitably challenged and adapted.
“Combining best-in-class technology and Almac expertise, our remote auditing service is now operational, accepted by industry regulators and built to support three components of a conventional industry audit. They include auditing of Almac Clinical Services’ global facilities, QP auditing of sponsors’ manufacturing sites and audits of Almac vendors’ facilities. This new service is the latest development in our ongoing program of solutions that will help sponsors face the challenges that the clinical supply chain of tomorrow may bring.”
1). Virtual auditing of Almac facilities for clients
A customised and comprehensive digital audit programme is agreed between Almac and the client as a first step in this process. The virtual audit is designed to deliver upon three core elements from the standard conventional site-based audit. They include a tour of Almac’s facilities to review manufacturing processes in operation; a document review session, harnessing secure content collaboration platforms and dialogue with Almac’s subject matter experts. Two virtual tour options are available for clients. Almac Clinical Services is providing 3D, pre-recorded virtual tours, plus 3D live-streaming virtual tours of Almac’s facilities.
Dialogue is held via interactive and collaborative technologies to facilitate remote communication for clients. This is a central part of the audit to ensure that areas of importance for sponsors are addressed as they would be if on-site, with a dedicated question and answer session with Almac’s team of global clinical supply experts.
2). Almac qualified persons (QP) quality audit of client sites
Almac Clinical Services is committed to ensuring clients uphold quality standards and regulatory compliance and ensure their contracted organisations supply goods and services that are fit for use and meet the terms of quality and technical agreements. Using the same technology to host customer audits, Almac’s QPs are carrying out due diligence audits to provide assurance that the relevant systems and processes are in place at sponsors’ manufacturing sites whilst addressing the EU regulatory expectations and enabling continuation in the supply of vital medicines to patients.
3). Quality audits of Almac suppliers
As businesses expand operations and supply chains across international borders, it is increasingly important to have a cohesive approach to quality, safety and sustainability goals. To ensure the reliability of our suppliers, Almac Clinical Services’ supplier quality team can harness the same interactive and secure technologies. Virtual auditing is a robust method to safeguard the same high standards of quality and regulatory compliance throughout the entire clinical supply chain.