Quality
At Acino, we meet and exceed the highest standards for our products while also continuously improving our offering through our own quality culture. Our global quality strategy encompasses all aspects of our business, from the relationships we develop to the products we deliver. And our quality policy greets every visitor and employee at every site entrance in Acino.
Approaching quality with patients in mind
Every product we make at Acino has a well regulated lifecycle. We carefully select our suppliers, who must meet the same high standards that we do. We validate and continuously monitor our manufacturing processes to guarantee they function as required. Each of our products is thoroughly tested to ensure it meets product specifications as well as regulatory standards.
The entire company embrace a quality mindset. All our employees receive GxP awareness training from day one, and are continuously trained. Our EU GMP certified sites in Europe demonstrate a consistent commitment to quality by successfully passing HA inspections and customer audits.
When you choose Acino, you are choosing reliable quality
- 100%
Passed HA inspections and customer audits
- 14+21
HA inspections and customer audits in 2024
- 300+
Quality employees
- 5
EU GMP certified centres
Our strengths and capabilities
- Quality Project Management
- Change Control
- Annual Product Quality Review Support (APQR)
- Complaint Management and Handing of Transport Damages
- Product Release Activities
- Business Document Management
- Supplier Quality Management
- Technical Product Support
- Quality Compliance Management
- Trainings
- Quality Management System
- PV QA Oversight
- Person in Plant (CMO Support where needed)
QA/QC in Switzerland
Our quality control labs meet and exceed the highest quality standards and requirements. We continuously invest in new equipment and latest technologies to improve our capabilities.
- 80+
Employees in Quality
- 1,200m2
QC area
- 32
HPLC instruments
- 30
Dissolution instruments
- 25, 30, 40 °C
Stability chambers
- 5,200+
Samples analysed in 2024
QA/QC in Ukraine
Our modern facility in Ukraine was designed and built in compliance with GMP ЕU norms; applying the highest Acino quality standards. The laboratories are equipped with state-of-art technology and our experts use hi-tech analysis methods to guarantee accurate, reliable and high-quality data in the shortest possible time to our customers.
- 79
Employees in Quality
- July 2024
Passed EU GMP and UA GMP inspections
- June 2024
Passed EAEU GMP inspection
- Certified
ISO 9001 / ISO 22000 / ISO 14 001 / ISO 45 001
QA/QC in Estonia
We offer the service of EU market release and compilation of product quality reviews for our customers. Our experienced specialists in QC use high-tech pixel-proof workflow to efficiently perform proofing of packaging artworks and braille text.
- 10+
Employees in Quality
- December 2023
Passed EU GMP inspection
QA/QC in the United Arab Emirates
Our quality control laboratory in Dubai has separate sections for wet chemistry, instrumentation and microbiology laboratory. The lab is equipped with the latest testing equipment sourced from well recognised names in the pharmaceutical industry.
- 28
Quality Employees
- June 2023
Passed EU GMP inspection
- February 2022
GCC regulatory audit
- FDA
21 CFR Part 11 compliant
Release excellence in Germany
We offer the service of EU market release from our office in the heart of Munich, Germany. We strive for excellence and enhance our processes continuously for even greater efficiency.
As a MAH of 650+ licenses in EU and Rest of the World (RoW), we ensure a better and faster accessibility to the medicinal product supply for customers across the globe.
- 6
Employees in Quality
- 300+
Licenses in EU & RoW
- October 2023
Passed EU GMP inspection
- December 2024
Passed EAEU GMP inspection
Partner With Us
We are growing fast organically and are also actively looking to expand our portfolio via in-licensing and acquisitions.
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