The GMP [14C] API manufacturing process begins with a conversation between you and Moravek GMP and radiochemistry specialists. Project scope of work, clinical requirements and scheduling are all discussed. All elements essential to your clinical trial’s success will be discussed in order to arrive at an appropriate scope of work and to ensure the success of your GMP [14C] API campaign.
GMP Solutions Offered by Moravek
- GMP [14C] API Manufacturing
For use in human clinical trials
- Technical Batch Synthesis
Used to confirm synthetic pathway and establish radiolabeled compound stability
- GMP HPLC Method Transfer, Development and Validation
Services include HPLC method transfer, method protocol, system suitability, and report, and are carried out utilizing six qualified HPLC and UPLCs
- GMP Analytical Services and GMP Purification of [14C] APIs
NMR of various nuclides, MS, GC/MS, LC/MS, HPLC, UPLC, Karl Fischer and other analytical services available
- Quality Assurance Release of [14C] API under GMP
Quality Assurance review and approval of all GMP production and analytical documentation prior to release of API
- GMP Temperature Controlled Stability Studies
NIST traceable temperature recording at +4, -20 and -80°C utilizing qualified HPLC systems
- Comprehensive Logistics Services Storage, chain of custody, dispensing, shipping to clinics worldwide, temperature tracking
Properly designed and implemented Quality Systems, including GMP Standard Operating Procedures, are essential to ensuring that your GMP [14C] API will succeed in receiving approval from regulatory bodies for use in a clinical trial.
The GMP Quality Assurance team at Moravek has over thirty years of industry experience in GMP API Manufacturing.
Moravek’s Quality Assurance team has worked closely with regulatory bodies and dozens of clients to design and implement comprehensive GMP compliant quality systems and operating procedures that consistently satisfy all essential compliance activities including procurement, quarantine and release of reagents, manufacturing, isolation, quality control, chain of custody, temperature tracking, proper labeling, documentation and release of GMP [14C] API while adhering to FDA GMP guidance ICH Q7A.
Since the addition of GMP ISO 7 Cleanrooms 2 and 3 in 2012, GMP Quality Systems and facilities at Moravek have successfully passed all client and regulatory body Quality Assurance audits and inspections, including a GMP inspection carried out by the California Department of Public Health. Moravek has passed all Quality Systems audits and inspections and was approved to manufacture GMP [14C] and API for clinical trials.
Moravek has manufactured over thirty GMP [14C] APIs since 2012, all of which have met both our client’s Quality Assurance criteria as well as the acceptance criteria of the clinical trial regulatory bodies.
Moravek welcomes your Quality Assurance onsite inspection of our GMP facilities and systems. Please contact us to schedule an inspection.
Production of APIs includes, but is not limited to:
- Compliant with FDA GMP guidance ICH Q7A
- Suitable for use in clinical trials
- Quarantine & release of [14C] API by Moravek Quality Assurance
- Analytical method transfer
- Validation of analytical method(s)
- Synthesis carried out in one of three highly engineered GMP suites
- Verification of production area cleanliness by TOC
- SOPs for all key activities
- All new glassware for synthesis
- Quarantine & release of materials by Moravek Quality Assurance
- GMP HPLC purification including all new media, tubing & glassware
- Master batch record (MBR)
- Technical [14C] batch prior to GMP synthesis to aid in preparation of MBR & to be utilized for stability testing
Analysis & Documentation
- GMP CoA certifying [14C] API is suitable for use in clinical trials
- HPLC, MS, & NMR analysis (as appropriate)
- TSE/BSE statement
- Copy of notebook pages* (incl. reagent sources, lot numbers & procedures)
*notebook pages will not include proprietary information
Logistics & Customer Service
- Weekly email updates
- Weekly teleconferences
- Initial (kick-off) teleconference
- Confirmation of storage/packaging conditions
- Shipping & storage tracking
Shipping & Storage
- Aliquot preparation
- Domestic & International door-to-door shipment
- Secure GMP storage at ambient, +4°C, -20°C, or -80°C
- Temperature logging during shipment