How a Quality Culture Contributes to Global Compliance

How a Quality Culture Contributes to Global Compliance

December 06, 2019PAP-Q4-19-CL-007

Almac Pharma Services successfully completed global regulatory GMP inspections at three different sites within two weeks, a milestone that reflects the company’s commitment to quality and global compliance.

Quality as a Core Value

As a global contract development and manufacturing organization (CDMO), Almac Pharma Services recognizes that quality determines the extent of our success. We prioritize our company-wide quality systems and ensure that they exceed global regulatory standards.

Quality is a core value for Almac and is embedded in our organization. It flows down to our business operations through our quality mission statement, which is translated into departmental objectives that are supported by individual objectives assigned to specific staff throughout the business.

Leveraging Internal Metrics

On a more detailed level, our commitment to quality is reflected in internal targets for quality metrics. These internal targets provide a measurement of our level of compliance and are used to identify opportunities for continuous improvement. They are challenging targets that we aim to improve on each year and thus enable Almac to stay one step ahead of regulatory expectations.

Importance of Regulatory Intelligence Gathering

While many countries around the world (approximately 60–70% of the markets supplied by Almac) accept EU and U.S. regulatory inspection results as sufficient, many countries do not. Some perform “desk-based” inspections in which documents are exchanged with the regulatory agency, but others conduct site inspections. As result, Almac must be prepared to host inspectors from many different countries with their own sets of regulations and different inspection styles and hot-button topics. Intelligence gathering, done in-house, through consultants and in partnership with our clients, is essential to ensuring compliance on a global scale.

Focused Inspection Planning

Regardless of whether an inspection is conducted by an authority from an emerging market or more established agencies or whether it is scheduled or unannounced, good preparedness embedded in a quality culture is the key to success — it is important to always have an element of inspection readiness within the business. Good planning involves the preparation of a strong internal team trained on how to host the inspectors and another team ready to manage the inspection. Each team rapidly responds to any questions asked by inspectors and promptly resolve any issues that are raised. This approach has helped Almac achieve the desired outcome for inspections: no critical issues or 483s.

Successful completion of these inspections at our multiple global facilities reflects our ongoing commitment to quality and teamwork across the entire organization.

Three Successful Tandem/Overlapping Inspections

Indeed, that was the recent result of not one but three inspections conducted by the U.S. Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in late August and early September 2019. Three global regulatory GMP inspections were successfully completed within two weeks at our Charnwood, UK facility, our Craigavon, Northern Ireland headquarters location and a site in Audubon, Pennsylvania.

The UK facility provides GMP development and manufacturing of solid oral dose clinical trial materials and the manufacture of commercial products. The global HQ site in Northern Ireland provides GMP and non-GMP pharmaceutical development, commercial-scale manufacturing and packaging of solid oral dose material, secondary labelling, serialization and distribution of drug products globally. Our U.S. facility in Audubon provides a range of specialized commercial packaging services, including complex kit assembly for medical devices, combination products and biologic packs.

The inspections of the UK sites were planned, and Almac was aware of them with a few months’ notice. The FDA’s inspection of the U.S. site was unannounced, however. The MHRA inspection resulted in no critical or major findings, while the two FDA inspections closed without any 483s being issued.

It was unprecedented for the Almac Pharma Services business to have three regulatory authority inspections within such a short period of time, and it is a great credit to the skilled and experienced teams involved across all locations that they resulted in a positive outcome. Successful completion of these inspections at our multiple global facilities reflects our ongoing commitment to quality and teamwork across the entire organization.

chat button