Quality Management System Consulting Services

Helping customers set up GMP quality management system, performing the gap analysis and providing  improvement advices and providing feasible suggestions to the enterprise on implementation of Chinese GMP, EU GMP, FDA cGMP,  WHO GMP and related laws and regulations, standard operating procedures .

Inspection mode with six systems is the FDA operational basis for on-site inspection which is also the standard of pharmaceutical enterprises for self-checking. Six systems include: production systems, facilities & equipment, laboratory control system, material system, packaging and labelling system, quality system.The quality system is the basis and core  of the six major systems.

Good Engineering Practice Management Consulting Services
Based ISPE guides -GEP project management ideas and methods, and combined with GMP of pharmaceutical industry at domestic and abroad. Providing customers requirements, design, pre-qualification, procurement bidding, construction, commissioning, qualification, acceptance, training, until the delivery of the whole process of engineering project management consulting services.