CRAIGAVON, Northern Ireland,
Aug. 11, 2020 /PRNewswire/
-- 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.
ENDS
Media Contact: media@almacgroup.com
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SOURCE Almac Group