16 Sep 2013, BioSpectrum Bureau , BioSpectrum
Singapore: China-based Tianyin Pharmaceutical (TPI) received GMP certification for its pre-extraction plant and formulate facilities.
Tianyin Pharmaceutical is a pharmaceutical company that specializes in patented biopharmaceutical, modernized traditional Chinese medicine (mTCM), branded generics and active pharmaceutical ingredients (API).
TPI manufacturing facilities including its pre-extraction plant and formulation facility have been awarded the GMP renewal status for the next three years till the end of 2015.
The new GMP standards, issued in 2011, provide the specification for pharmaceutical manufacturing facility in the criteria such as quality assurance, quality control and quality risk management, organization and personnel regulations, premises and facilities guidelines.
It also provides specifications for equipment, materials and production criteria, qualification and validation procedure, documentation management, contract manufacture and analysis, product distribution recalls, self inspections, and general and supplementary provisions.