Quality assurance (QA) is a crucial process that involves a series of rigorous tests and document management to ensure the radiochemical purity, chemical purity, specific activity, structure and stability of the radiolabeled products, thereby providing reliable and high-quality materials for downstream studies. The strict QA is a necessary condition to comply with regulatory requirements, and the foundation for the success of new drug development.
Our quality assurance team operates independently from the production department and is responsible for overseeing every aspect of the entire process to ensure compliance with standards and consistency. From the procurement of raw materials to the release of the final product, the quality assurance team implements and enforces standardized operating procedures (SOPs) consistent with ICH Q7 GMP guidelines. The team conducts audits, manages change control, and ensures that all personnel have received appropriate training for handling radioactive substances and GMP protocols. Before the delivery of any 14C-labeled APIs, the quality assurance experts review complete manufacturing and testing documents, including batch records, quality control data, and certificates of analysis, to ensure that the APIs meet all pre-defined specifications and regulatory requirements. Only after this meticulous review does QA formally release the batch for use.
Amerigo Scientific focuses on quality as the core of our service to ensure that the GMP 14C-labeled APIs meet the agreed-upon release specifications and all essential regulatory requirements. Our quality assurance team has extensive experience in the manufacturing of GMP APIs and are responsible for supervising all aspects of the GMP production process and quality system, including:
- Procurement, quarantine, and release of materials
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- Production (synthesis, purification, dilution, etc.)
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- Labeling and document preparation
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