We consider quality control as one of the key factors contributing to our success. We make every effort to implement stringent quality control measures to ensure the highest standards of product quality.
We have established our quality control system and adopted systematic standard operating procedures that are strictly in compliance with the GMP standards of the PRC and Australia and the USP.
PuraPharm places great emphasis on maintaining and improving the quality of its products and has the following quality procedures in place:
Independent Quality Control System
We have a comprehensively designed quality control system which incorporates good manufacturing practice, quality control over production and relevant risk management measures
Testing of raw materials purchased
Our procurement team and medical information and resource team carefully select suppliers based on quality of raw materials, as well as suppliers’ experience, their operation scales and their production bases. We sample test each batch of shipment of raw materials to verify their ingredients and quality in accordance with our stringent standards. We also document the production bases of all raw materials to ensure their sources are traceable.
Production process in compliance with GMP standards
We have established standard procedures for handling materials and products. Our procedures are designed to ensure that the materials and products are properly received, stored, distributed and delivered in order to prevent any cross-contamination and mix-up of Chinese herbal extracts and Chinese medicine products. Our manufacturing operations follow clearly defined standard production procedures.
In addition, we have established and implemented policies and measures for the hygiene control of our premises and equipment. All of the production equipment in direct contact with our raw materials and products are made of high quality stainless steels and each production process in direct contact with our raw materials and products is carried out in our clean production environment.
Testing of products internally and by third party independent testing agencies
Our quality control team monitors every stage of our manufacturing process to ensure that these processes comply with our standard operating procedures and that our products meet our stringent quality standards. Aside from the safety testing conducted by our in-house testing laboratory, we also engage independent third party laboratories to perform safety tests on our finished products, ensuring local and international compliance. Every batch of our products must pass the safety tests of heavy metals, toxic elements, pesticide residues and microbial limits before they can be released into the market, thereby guaranteeing its reliability and safety.
Using latest testing technologies and equipment to enhance quality control
We increase our quality control standards by using the latest testing technologies and analytical equipment, such as thin-layer chromatograph (TLC), plant DNA fingerprinting, Fourier transform infrared spectrophotometry (FTIR), inductive coupled plasma mass spectrometry (ICP-MS), high performance liquid chromatograph (HPLC) and ultra-high performance liquid chromatography (UPLC). These technologies and equipment help to ensure the authenticity, quality, reliability and safety of the raw herbs as well as our finished products.
Channel for customer feedback and complaint
We conduct investigations according to our standard operating procedures. We provide training and presentations to educate our customers on the proper use of our products and provide channels to collect their feedback on the quality and curative efficacy of our products. We have specific procedures on handling customer complaints and provide for the contingency for any adverse reaction from patient to our products. In order to provide for all possible contingencies, our system is designed to recall promptly and effectively from the market those products which may be suspected to be defective.