SERATEC's Quality Assurance System ensures that the manufacturing process conforms to Seratec documented methods. Raw materials are sampled, tested and approved before any further chemical processes. In-process records are compiled and key-intermediates sampled to be considered as raw materials to pursue the process. The activities of in-process Quality Assurance and the Quality Control Laboratories ensure that the products and processes of SERATEC maintain consistent high quality and continue to comply with the most stringent international codes of Good Manufacturing Practice. This enables our customers to have total confidence in SERATEC's products.
Our Quality Assurance System also regulates labeling, inspection and auditing, preventive and corrective actions... In this way we can guaranteed that final product complies to controlled specifications and procedures.
All products and services provided by SERATEC are elaborated in strict compliance with GMP:
each by-product, related substances, key intermediates or reference standards may be isolated during development process and can be provided by synthesis.
any impurities, whether present in the starting materials, or formed during processing may be kept to an acceptable level during subsequent stages of processing.
SERATEC's Quality Control conducts in process and final testing on each lot to conform to internal, monographs and/or customer specifications, maintaining and archiving all batch records. Analytical results are documented in a lot-specific Certificate of Analysis through our analytical test capabilities which include: melting points; UV-Vis, FT-IR,1H & 13C NMR analysis and identifications / aqueous, non-aqueous Karl Fisher titrations, HPLC and GC assays.
SERATEC products are backed up by a technical services staff of research specialists in chemistry and biology with a combined experience of over 100 years. They are always available to assist you resolve any research problem that you migth have.This level of expertise allows SERATEC to offer high quality, custom synthesis services, intermediates, or active ingredients in one to hundreds kilograms quantities which are in full conformity with pharmacopoeia or any other set specifications.
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