∙ Assistance and solutions
to allow your company in maintaining and complying with cGMP
requirements
∙ Technical support in the
front or in the back office during pre-, actual and post-GMP audits by
your Corporate, TGA and Contract Giver auditors
. GMP audits in APIs,
pharmaceuticals, complementary products, consumer goods, medical and
therapeutic devices, sterile and non-sterile products
∙ Assistance in achieving
compliance to your GMP audit observations from your Internal, Third
Party manufacturer or Supplier and
Pre-contract audits
∙ Assistance in
preparation, updating and upgrading your factory Quality systems and
processes
∙ Technical and GMP
training and facilitating your training requirements which can be
tailored to suit and meet your requirements
∙ Assistance in updating
and upgrading your documentation requirements for your SOPs, Quality
Manual, Site Master File, batch documents, Validation
Master Plan, etc
∙ Temporary filling-in key
positions and relieving the pressure of time and GMP compliance while
you seek the right person
∙ Assistance in GMP
building requirements
. Project management
∙ Assistance in QC and GLP
requirements
∙ Assistance in setting up
or reviewing product stability studies programme
. Warehousing requirements
and temperature sensitive shipping requirements
. Assistance with new
product introduction
. Contract release for
supply function
We
provide:
Professional service at
affordable and competitive rates. Call us to discuss your
requirements.
CV of Dr. Chen LIM
- PhD, FRACI
∙ Chen is Australian
trained and has worked for 23 years with multinational companies such
as Riker Laboratories, ICI Pharmaceutical, Janssen-Cilag and Johnson
& Johnson Medical
∙ Also worked for a spell
with toll manufacturer Ensign Laboratories
∙ Experience with
Australian TGA, New Zealand Medsafe, USA FDA, SFDA (China), EU and WHO
GMP requirements
∙ Since year 2000, Chen has
been managing his own consulting company
∙ Had hands on experience
on the QC laboratory bench and in the factory
∙ Extensive and broad
exposure, experience, skill and knowledge in handling the manufacturing
and packaging of:
o Therapeutics
o OTC products
o Complementary
medicines
o Devices
o Veterinary
products
o Food products
o Cosmetics
∙
Experiences in handling:
o solid dose
products (tablets, capsules, powder)
o creams and
liquids
o aerosol
products
o sterile and
non-sterile products manufacturing and packaging
o food product
manufacturing and packaging
o GMP auditing
o warehousing
o temperature
sensitive product storage and shipping requirements
o all aspects
of validation
o documentation
system set-up, update and upgrade
o stability
studies and monitoring
o GMP training
and facilitating
o GMP building
requirements
o Project
management
o QC and GLP
requirements
