Quality management and assurance are at the core of our business, setting us apart as an organization
At Douglas CDMO, we are committed to being a premier contract development and manufacturing partner for pharma and biotech clients and patients alike. We strive for unparalleled leadership, compliance, and service at every stage of the drug development project life cycle.
Our philosophy
Quality is the responsibility of every employee. The high standard of our products and services is a competitive advantage upholding Douglas’ reputation as a trusted and reliable CDMO partner to innovative drug product organizations.
Through innovation, our quality operating procedure seeks to add value to every step of the design, development, production, and distribution process. Douglas CDMO is well versed in risk-based decision-making processes made successful by our tried and tested scientific judgement and positive work environment.
With a focus on continuous improvement, we proactively review our systems and engage with our clients to ensure we always deliver the highest value to their businesses.
In 2024, Douglas was one of only 9 companies selected globally to participate in the FDA’s Quality Management Maturity Pilot Study.
The Quality Management Maturity (QMM) program is voluntary and designed to assist drug manufacturers in achieving higher levels of quality management maturity at their facilities. By participating, companies are assessed on their overall quality management systems beyond cGMP requirements, and provided with improvement opportunities. The aim is to reduce the occurrence of product quality issues and improve an organization’s ability to maintain performance during unexpected supply chain disruptions.
“We are delighted to be one of the few companies selected to participate. The QMM program goes beyond good manufacturing practice (cGMP) requirements, which aligns with our commitment to delivering excellence at all levels of our organization.”
Beatrijs Van Liedekerke, General Manager of Quality at Douglas
Our quality first mindset
Our promise to customers is simple: we are dedicated to upholding the current industry standards and committed to offering quality pharmaceutical products, processes, and services to achieve customer and patient satisfaction. The necessary environment, training, and tools are available to support this commitment.
We will maintain a quality system designed to comply with cGMP requirements as defined by the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and foreign regulatory agencies.
Douglas Manufacturing is inspected by the local regulatory authority Medsafe as well as the US FDA.
Quality assurance through international accreditations
Thanks to secured agreements and accreditations with our international market partners, we have the ability to export to the EU without the need to retest for quality.
Douglas is certified to (PIC/S) Guide to Good Manufacturing Practice for Medicine, by New Zealand’s health authority, Medsafe.
This allows Douglas to supply to most PIC/S participating authorities without further need for GMP inspection.
This certification is recognised under the mutual recognition agreement (MRA) with European countries and the UK, allowing Douglas to supply to EU and UK without retesting or further need for GMP inspection.
Medsafe audits are also accepted by Australia’s Therapeutic Goods Administration (TGA).
Our quality management systems
Our quality mangement system (QMS) follows the PIC/S GMP Guide for Medicinal Products, Part 1 and the USFDA Code of Federal Regulations, 21 CFR Part 11.
We include the chapters of the PIC/S code in our Quality Manual, including Quality Risk Management (QRM): Data Integrity following ALCOA+ principles; ICH guidelines for stability testing and for compliant testing and laboratory investigations.
GMP inspections over the past 5 years
- Medsafe, New Zealand: Inspected every 18 months, with the most recent audit completed in May 2024.
- US FDA: Last inspected in October 2019.