GMP Consulting
Dr Chen Lim is a Pharmaceutical GMP Consultant with in-depth and broad experience through working with multi-national companies to TGA, EU and FDA GMP requirements. He consults on Good Manufacturing Practice (GMP), Pharmaceutical Validation, Pharmaceutical GMP audit, GMP training and documentation, Quality Control (QC) and Good Laboratory Practice (GLP) for TGA (Australia), New Zealand, US FDA, SFDA (China), EU, Asian and WHO GMP requirements in the manufacture and handling of:
- solid dose products (tablets, capsules, powder)
- creams and liquids
- aerosol products
- sterile and non-sterile products manufacturing and packaging
- food product manufacturing and packaging
- Veterinary products
- pharmaceutical GMP auditing
- warehousing
- temperature sensitive product storage and shipping requirements
- pharmaceutical validation
- documentation system set-up, update and upgrade
- stability studies and monitoring
- GMP training and documentation
- GMP building requirements
- Project management
- QC and GLP requirements
- Regulatory submissions
Dr Chen Lim PhD FRACI, is Australian trained and has worked for 23 years with multinational companies such as Riker Laboratories, ICI Pharmaceutical, Janssen-Cilag and Johnson & Johnson Medical.
He has worked with toll manufacturer Ensign Laboratories and has extensive experience with Australian, New Zealand, US FDA, China SFDA, EU, Asian and WHO GMP requirements. He has a practical working knowledge of pharmaceutical manufacturing and packaging, QC laboratory, pharmaceutical validation, GMP documentation and Quality Control practices.
Since 2000, Chen, a pharmaceutical consultant, has managed C. Lim Consulting Pty Ltd; providing services both to Australian companies and many international companies in Asia and China.
Dr Lim has extensive and broad exposure, experience, skill and knowledge in the manufacturing and packaging of:
- Therapeutics
- OTC products
- Complementary medicines
- Devices
- Veterinary products
- Food products
- Cosmetics