Quality Assurance

At SynCo, we are committed to our client’s success, so it is our mission to help your product reach its full potential with the highest possible quality. SynCo has a long and very successful track record in inspections of its biopharmaceutical production facilities in Amsterdam, by its clients and the regulatory authorities. 

Operating as a CMO demands constant evaluation of our quality systems. To achieve the high quality standards SynCo’s Quality Assurance works closely with SynCo’s internal organization and our clients to ensure that the project meets full regulatory compliance.  SynCo is committed to continuous quality improvements and our goal is to provide biopharmaceutical products to our customers that meet the highest safety and quality standards. “Trust us to make it right”  

The Quality Assurance group provides and maintains the GMP quality system within SynCo and supports all aspects of the GMP biopharmaceutical manufacture to ensure the products meets the highest quality standard and regulatory compliance.

Quality Assurance within SynCo will assist and is responsible for: 

• Disposition of bulk drug substance and drug product   
• Raw material release
• Qualified Person release
• Quality Agreements with customers and suppliers
• Client and regulatory audits
• Internal audits
• Vendor Qualification
• Deviation and CAPA systems
• Change Control
• Annual Product Review
• Training and compliance with the requirements of SynCo’s quality system
• GMP and Regulatory Support for INDs, IMPDs, DMFs, MAAs and BLA

Inspection history 

SynCo’s facilities have been a licensed manufacturing site for drug substance and small volume parenterals (drug product) since 1992 and are regularly inspected on behalf of EMA by the Dutch regulatory authorities. 

In addition to EMA compliance, SynCo’s facilities have been inspected and approved by foreign regulatory authorities (Korean FDA, Health Canada and ANVISA) in view of the licensed products produced at SynCo that are registered in many countries outside Europe. 

Since several of SynCo’s clients have products in late stage development that will be launched onto the US market, SynCo expects multiple US FDA Pre-Approval Inspections (PAIs) over the next few years. The first PAI is anticipated for Q1, 2012 and additional PAIs are expected in 2012 and 2013. 

Next to the regulatory authorities SynCo is also frequently inspected by its clients or prospects for both the manufacture of drug substances and drug products. 

Regulatory Affairs Support 

SynCo has a strong track record in supporting clients through the manufacture of clinical trial material and licensed products. With this experience comes the expertise to be able to offer our clients support in their regulatory filings with respect to manufacturing. SynCo’s two full-time employed Qualified Persons (QP) and members of the Quality team work closely with our clients to ensure that potential issues are brought to light and addressed within the work program, as well as providing relevant and appropriate documentation and data in a timely manner. Over the years, SynCo has successfully supported its clients in a number of INDs, IMPDs, DMFs, MAAs and BLAs.