Fill & Finish | Quality Assurance and Quality Control

Quality Assurance

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

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

Operating as a CMO demands constant evaluation of our quality systems. To meet the high quality standards required SynCo’s Quality Assurance department works closely with SynCo’s internal organization and our clients to ensure that each 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”

Quality Control

The Quality Control (QC) department of SynCo is is responsible for sampling and testing a wide range of materials including raw materials, in-process samples, drug substance samples, drug product samples, stability samples and environmental monitoring samples. SynCo’s QC staff is trained in state-of-the-art analytical techniques. The instruments SynCo employs are validated according to current guidelines (including ICH) and the methods of analysis meet all international requirements and will be qualified / validated for the specific product development stage.

SynCo’s QC department consist of three groups, the Microbiology group, the Analytical (Bio)chemistry group and the Transfer and Validation group. Both the Microbiology group and the Analytical group are involved in raw material testing, in-process control testing, bulk drug substance testing, drug product testing and stability testing. The Transfer and Validation group is responsible for the transfer of analytical methods and set-up of new methods to support our client production processes.