Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) cover a wide range of operational issuesrelating to the manufacturing environment. The general principles are considered in numerous guidance documents at both national and international level e.g. ICH, EMEA, FDA.
Recent directives also consider minimising risks from early stage clinical trial product. The new directives, requiring product to be produced according to GMP, is increasing the burden on early stage companies and research groups to assure GMP manufacturing capacity and experience in producing product.
Rodon outsources and manages the manufacture of client’s products, for all stages of clinical trials and commercial use, with the services of Contract Manufacturing Organisations (CMO) and Contract Analytical Laboratories (CAL) with proven capabilities in GMP/GLP standards of operation. A suitable CMO/CAL is identified early and a close relationship is developed, at both the commercial and technical level, to ensure the efficiency and success of the project.
Processes have been developed and transferred into client’s manufacturing facilities and third party CMOs. Prior to transfer the process and analytics are well characterised and demonstrated to be appropriate, consistent and robust. With this experience Rodon can effect a rapid and successful transfer of a process to ensure that product is available in appropriate time for whatever stage of development.
A dedicated and knowledgeable project manager assures continuing and effective planning, co-ordination and communication between all parties, at all levels, throughout the project.