Dr. Chen Lim of C. Lim Consulting Pty Ltd is Australian trained with more than 25 years of experience, both hands on and in management roles, with large pharmaceutical multinationals and also with medium to small businesses. He has extensive and broad experience in GMP requirements for Australian, New Zealand, USFDA, China SFDA, PIC/S and Asian countries.
C. Lim Consulting Pty Ltd provides assistance in Gap analysis (GMP audits), resolving GMP compliance issues and the upgrading and maintenance of production and technical systems and processes. We offer simple and practical solutions which are fit for purpose.
We provide assistance in reviewing and upgrading your
o Documentation system including Site Master File
o QA and QC (GLP) requirements
o Validation status and compliance
o Stability studies and stability monitoring requirements
o Training requirements
o Warehousing requirements
o Storage and Shipping validation of temperature sensitive products
o Validation of Gamma sterilization process
o GMP building requirements
o GMP systems and processes like Change control, Calibration, Stability studies, Factory and Equipment maintenance, etc
