The Importance of A GMP Certification

A supplier should hold GMP (Good Manufacturing Practices) certification in order to ensure safe and qualitative packaging. Hence our drugdu (Ddu) has collaborated with world-class Pharmaceutical Machinery Packaging and Materials Supplier named 'Jiangyin Tejie Rubber & Plastic Co., Ltd., in order to deliver sturdy, user-friendly machineries available in varied capacities with minimal power consumption.

'Jiangyin Tejie Rubber & Plastic Co., Ltd.

This China based Pharmaceutical Machinery Packaging and Materials Supplier produce pharma based packaging materials for antibiotics, infusion, blood collection tubes, freeze drying and polyisoprene gasket. They are specialized in producing 3 billion ISO9001 certified butyl rubber stoppers every year. Their major products include Teflon coated injection vial rubber stopper, PP or PE Euro cap for infusion container, flip off cap, glass bottle rubber stopper, lyophilization rubber stopper etc. The products were exported to Africa, America, Europe, Middle East and South East Asia.

This company has got 20 years of R&D and production experience of pharma packaging materials. As per the international GMP sterilization standards, their production unit is well equipped with a 300,000-grade vulcanizing room, a 100,000-grade trimming room, a 10,000-grade cleansing and 100-grade packing room. They have also introduced high-speed detection equipment to ensure the quality of stoppers.

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Ddu College：Pharmacovigilance

Background

Pharmacovigilance consists of a combination of the wording pharmaco- and vigilance: Pharmakon (Latin means "medicine, pharmacy"), vigilare (Latin means "alert, vigilant").In 1974, French first raised the word “pharmacovigilance”, since then its concept and meaning are constantly evolving and developing. Today's pharmacovigilance does not simply represent a monitoring report of adverse drug reactions, but it focuses on adverse drug reactions or ADR particularly.A recognized explanation for adverse drug reactions is for those harmful and undesired drug reactions that occur during the prevention, diagnosis or treatment of a disease or the regulation of physiological functions at normal use doses.

Pharmacovigilance

A discipline that collects, monitors, researches, and evaluates information about health care providers and patients regarding to the adverse drug reactions , biological products, herbs, and traditional medicine.

Main feature

  "Pharmacovigilance" belongs to the scope of the public health care system, a macroscopic and large-scale implementation system which is generally operated by state or regional government agencies to implement supervision and enforcement.The difference between "Pharmacovigilance" and "Monitoring for adverse drug reaction":The pharmacovigilance covers the entire process from drug research and development to marketing, while adverse drug reaction monitoring refers only to the monitoring of drugs after they are marketed.The monitoring targets are different: the adverse drug reaction monitoring targets the qualified drugs, while the pharmacovigilance refers to drugs other than qualified drugs such as drugs below the legal standards, drugs and compounds or interactions between drugs and foods and so on.The work contents are different: pharmacovigilance duty range includes monitoring of  adverse drug reactions and other tasks which are finding the medication errors, checking the lack of efficacy, using drugs for indications without adequate scientific evidence or approval, reporting acute and chronic poisoning cases, evaluating drug-related mortality and detecting drug abuse and misuse.  

Domestic development status

Late beginning with a slow developing speed is the current reality of China's pharmacovigilance development.At present, the national pharmacovigilance process is mainly constructed, managed, and implemented by China Food and Drug Administration (CFDA) and the National Center for Adverse Drug Reaction Monitoring."Drug Adverse Reaction Reporting and Monitoring Management Measures" -  2011 Edition is the only "pharmacovigilance" in China that can refer to relevant policies and regulations.The official authoritative journals for domestic pharmacovigilance information are "Chinese pharmacovigilance" and "Adverse Drug Reaction Journal", which will update the latest pharmacovigilance information inside and outside the country.

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