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AlphaPharma Consulting has over 25 years experience
in implementing current Good Manufacturing Practice (cGMP) requirements
for international pharmaceutical, biotechnology and active pharmaceutical
ingredient companies. Based in Bangkok, Thailand, AlphaPharma is
ideally located for companies in the Asian region.
AlphaPharma has worked with many Companies in Asia, especially India,
to effectively implement and maintain Regulatory Standards of:
US
FDA
MCA (now MHRA)
TGA
MCC
WHO
Schedule M, India |
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Companies manufacturing formulated pharmaceutical
products (sterile and nonsterile), biotechnology products and active
pharmaceutical ingredients (API's) for home and overseas markets
must meet prescribed standards of Current Good Manufacturing Practice
(cGMP). To effectively implement and meet regulatory requirements
associated with these standards, AlphaPharma offers consulting services
covering the following.
Current Good Manufacturing
Practice (cGMP)
Quality Management,
covering all aspects of Good Laboratory Practice (GLP)
Validation and
Qualification
Regulatory Agency
Documentation
Mr. Derek Smith, the principal consultant of AlphaPharma Consulting,
has held management positions in the pharmaceutical industry in
a number of countries. In addition to industry experience, he also
worked for the Therapeutic Goods Administration (TGA) of Australia
as a senior GMP auditor and was responsible for conducting GMP and
Quality System audits of companies both at home and overseas.
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