Manufacturing standards / Quality assurance

Our quality management group has pharmaceutical industry specialists dedicated to ensuring our products comply with the relevant monographs, and are also manufactured in line with Good Manufacturing Practice (GMP).

It is our policy for all our pharma grade products to comply with the relevant legal requirements relating to the countries in which our products are made and sold.

We operate a Quality Assurance program under which management systems are developed to fulfill the necessary requirements for Product Safety and Product Quality in our manufacturing sites, supply chain and associated toll processing operations.

Timely and accurate information on all matters of product safety will be provided to customers, appropriate government agencies and the public at large.

Cornerstones of our Quality Assurance program:

• ISO 9001 certified plants throughout Europe
• Most excipient channels are in line with IPEC GMP guidelines for pharmaceutical excipients
• Production of IV-glucose and IV-mannitol in line with ICHQ7a GMP guidelines
• In-process control
• Specialized packaging
• Full traceability
• Compliance with leading compendia monographs
• Environmental management systems

Regulatory insight

Within our team we have specialists that closely follow the pharmaceutical regulatory environment. The regulatory environment of the pharmaceutical industry is constantly changing and we recognize the need not only to track these changes but also more importantly to anticipate and bring about change, driving forward improved methods for the way in which excipients are used and manufactured.

To ensure that we are at the forefront of these changes, we actively participate in the European Pharmacopoeia and related harmonization committees.

We are also a member of the International Pharmaceutical Excipients Council Europe (IPEC) and the Active Pharmaceutical Ingredients Committee (APIC).