SynConnection is EMEA GMP certified by the Dutch Health Authorities and is regularly inspected by both local authorities and US-EU based pharmaceutical companies. SynConnection has a GMP manufacturing license in place for the manufacture and release of both drug substances and formulated drug products. Our quality system is based on:
- Guidance for Industry, Q7 GMP Guidance for API.
- EudraLex: The Rules Governing Medicinal Products in the European Union Volume 4; GMP; Medicinal Products for Human and Veterinary Use, Part I: Basic Requirements for Drug Products. (F-license). Part II: Basic Requirements for API used as Starting Materials.
- Analytical validation following the guidelines described in ICH Q2(R1).
- Development and Manufacture of Drug Substances as described im ICH Q11
The team of SynConnection is intimately familiar with GMP manufacturing and analytical testing and all technical, regulatory, and quality aspects of drug development. Out-of-Specifications, Corrective and Preventive Actions, Change Control, Complaints and Recall procedures are in place.
Materials Management System
All materials are procured from reputable and qualified suppliers. The suppliers have been audited by at least a questionnaire or if relevant a physical audit. non-GMP manufacturing starting materials, solvents, reagents, and all auxiliary substances such as salts, are approved based on a use-test in our laboratory. The use testing of starting materials is part of the technology transfer phase of the project wherein the synthesis protocols are piloted. GMP manufacturing starting materials, solvents, reagents, and all auxiliary substances such as salts, are released based on:
- The Certificate of Analysis provided by the supplier
- The TSE/BSE statement, provided by the supplier
- GMO statement to be discussed, or on basis of risk assessment
- An appropriate identity test performed in our laboratory
- A use-test performed in our laboratory
- If needed, for critical starting materials an in house purity test is performed
- For validation studies and commercial manufacturing, a full release analysis of the raw materials will be conducted