JCM Begins Operation and Aims for GMP certification in November
Press Release Source: Tianyin Pharmaceutical Co., Inc. On Monday October 24, 2011, 11:03 am
CHENGDU, China, Oct. 24, 2011 /PRNewswire-Asia-FirstCall/ -- Tianyin Pharmaceutical Co., Inc. (NYSE Amex: TPI, or the "Company"), a pharmaceutical company that specializes in the development and sale of patented biopharmaceutical medicine, modernized traditional Chinese medicine, branded generics and active pharmaceutical ingredients (API) announced that the Jiangchuan Macrolide Facility (JCM) has began its operation manufacturing Azithromycin raw material.
The Company is targeting for Good Manufacturing Practice (GMP) inspection and certification in November.
About GMP
GMP are a set of comprehensive quality management systems required for pharmaceutical manufacturing covering the manufacture and testing of pharmaceuticals including APIs, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production that ensure the quality of a product.
GMP certification is conducted based on several underlying basic principles: 1) Clearly defined manufacturing processes that are controlled with critical processes validated to ensure consistency and compliance with specifications during the production; 2) Good Documentation Practices; 3) Operators are trained to carry out and document procedures; 4) Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were carried out and that ensure the quantity and quality of the drug; 5) Records of manufacture and distribution that trace the complete history of a batch are retained in a comprehensible and accessible form. 6) The distribution of the drugs minimizes any risk to their quality; 7) A system is available for recalling any batch of drug from sale; 8) Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.
surf's up......crikey
