We provide a detailed evaluation of the state of the client existing processes, identifying opportunities for improvement and unmet needs. This is particularly valuable for those clients that are facing the need, for the first time, to adapt their processes, infrastructure and quality systems to comply with the GMP standards.
We provide expert advice in the process of transferring and setting up new GMP processes, helping to define suitable scale-up and quality control solutions for those clients needing to adapt their products and processes from the R&D domain to a standardised GMP production or when these processes need to be transferred to a new manufacturing facility or CMO.
FULL GMP IMPLEMENTATION
We provide support to clients that require integral advice on the implementation, training and certification of GMP regulations in the domain of Advanced Therapies and Innovative Medicines.
We provide personalised advice to all our clients, finding specific solutions to the needs of each manufacturing process including the design of GMP compliant quality controls, planning and sourcing of validation techniques, the upgrade and overhaul of manufacturing facilities, selecting appropriate clothing for each controlled area as well as defining the corresponding work and access rules.
QUALITY MANAGEMENT ADVICE
We provide hands-on help in managing and upgrading the Quality System including documentation, management of non-conformities, change controls, and risk management.
We carry out quality documentation and manufacturing audits in-situ, developing action plans to implement corrective and preventive actions, with the goal of ensuring the success of our clients during regulatory inspections. We also carry out external audits at our client’s subcontracted partners (CMOs) and assess their suppliers.
QUALITY DOCUMENTATION PREPARATION
We prepare specific documentation including writing-up standard operating procedures adapted to our client’s needs and quality systems, complying with the applicable quality regulations.
We offer specialised training programmes covering the different regulatory aspects pertaining to specific regulations, development, manufacturing and quality systems. (See Training section).