Moravek’s rigorous Pharmaceutical Quality System is consistent with ICH Q7 Section 19 which has been adopted by the FDA, EMA, and MHRA and provides Good Manufacturing Practice (GMP) guidance for the synthesis of radiolabeled Active Pharmaceutical Ingredients (APIs) for Use in Clinical Trials.
Pharmaceutical Quality System
The Moravek cGMP Quality System has been continuously improved by implementing feedback received from hosting over one hundred Quality Assurance (QA) audits by many leading pharmaceutical companies.
Some examples of state-of-the-art improvements include 21 CFR Part 11 compliant Agilent OpenLab Enterprise Content Management (ECM), a comprehensive Rees Scientific Environmental Monitoring System (EMS) and a Cummins 500 kW backup power solution for the entire Moravek facility.
Moravek’s Pharmaceutical Quality System has successfully supported over 100 clinical trials worldwide. All cGMP APIs are supplied with a comprehensive data package that describes the synthesis, analysis, release, and stability of the product.
Our custom radiosynthesis process consistently provides acceptable cGMP compliance and Quality Assurance for early stage drug studies.
The Moravek cGMP Quality System includes:
• Quality Manual with relevant SOPs organized by activity
• SOPs govern all stages of production, analysis, and release
• Appropriate training for each staff member working on your project, which is recorded by our independent QA department
• Product specifications are set in cooperation with the client
• Batch records are used for synthesis, purification, and dilution stages of the project
• Method transfer protocol including sample preparation governs method transfer
• Your API will be released by our independent QA department
• 21 CFR Part 11 compliant data generation and storage solutions include:
o Agilent OpenLab Enterprise Content Management System (ECM)
o Rees Scientific temperature, pressure and humidity Environmental Monitoring System (EMS)
o Mettler Toledo LabX Balance Software
The quality of our products is assured by experienced staff using qualified equipment and documented with a 21 CFR Part 11 compliant data system. Techniques routinely carried out are:
• HPLC and UPLC with radio and UV detection: for radiochemical and chemical purity
• Mass spectrometry: for structural confirmation and specific activity
• NMR: for structural confirmation
• ICP-MS: for trace metals analysis
• GC-MS headspace: for residual solvent analysis
• XRPD: for confirmation of crystalline structure
Supporting documentation accompanying each cGMP API includes at a minimum:
• Analytical method transfer protocol
• Formal release specification that is agreed to by client and Moravek QA
• Synthesis, purification and dilution batch records
• Certificate of Analysis
• TSE/BSE Certificate
The quality of each cGMP API provided by Moravek is verified in a reproducible manner. Organized and comprehensive documentation supplied along with every API demonstrates the product is suitable for use in a clinical trial.