Quality system

Transactiva has defined a quality system to ensure an appropriate and consistent quality of the plant tissues to be used as starting raw material in the extraction and purification of pharmaceutical products. The system acknowledges EMA guidelines and regulations concerning the current good agricultural and collection practices (cGACP – EMEA/HMPC/246816/2005 and EMEA/CHMP/BWP/48316/2006), integrating them with specific measures designed to produce the molecule of interest under safe and hygienic conditions as well as to preserve it during the phases of plant cultivation, harvesting, processing and storage.

The quality system involves all aspects of the productive cycle, including: quality assurance, personnel training and qualification, management of equipment and facilities, the documentation for traceability of every action. The system is based upon a series of internal rules for planning and control (Standard Operative Procedures, SOPs), batch records, protocols and other documents of qualification, containing all the theoretical and practical information needed to comply the requirements set by regulatory agencies.

All activities affecting quality are specified in writing, possible deviations from established procedures are documented and explained, and the personnel is highly trained. No materials may be released or used without prior consultation and document approval by the quality control unit.

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