subject: Pharmaceutical Packaging: The First Hurdle To Ensure Drug Safety [print this page] The world's leading pharmaceutical companies?? AstraZeneca Pharmaceutical Co., Ltd. by the former Swedish company Astra Zeneca and the former British company merger in 1999, mainly engaged in Prescription drugs Research and development. Production and sales. Company is headquartered in London. R & D headquarters in Sweden. Has 11 global R & D centers, 27 production bases. Product sales in over 100 countries and territories. AstraZeneca Pharmaceutical Co., Ltd. China headquarters in Shanghai. In mainland China, with offices in 15 major cities. In 2001, AstraZeneca made in China, a landmark step, the total Investment Amounted to 134 million U.S. dollars in China production base completed and commissioned. AstraZeneca in Asia is the largest investment project. April 21, 2006. AstraZeneca Pharmaceutical Co., Ltd. ushered in another milestone in the history of China. AstraZeneca day plant in Wuxi, Jiangsu Province, held the fifth anniversary of opening ceremony. In the opening ceremony, the guests together for the new world-class facility Packaging Line Opening. This packaging line total amount of 31 million yuan investment. Wuxi plant will increase annual production capacity of about 40 million boxes. In such a large production capacity under. Drug manufacturers to manage the enterprise supply chain can become long-term development of key end-users.
Drugs as a special commodity. A double feature?? Security , Effectiveness. In the evaluation of Drug Quality Good or bad when. People in the study to assess its clinical efficacy, it should also attach importance to its extensive safety features.
A long time. People talk about drug safety features often only consider the traditional sense of the drug (active ingredient) safety factors. Concerned about the safety of their drugs. Mainly the characteristics of drug toxicology and adverse reactions (serious adverse reactions and unexpected adverse reactions, side effects) and so on. But for the safety of drug quality factors?? Drugs Preparation Of Packaging materials . Not a cause for attention. Or simply not been aware of.
Pharmaceutical Packaging Improper form. Improper choice of packaging materials. Storage environment. Will give a negative impact on the quality of medicines.
"China Pharmacopoeia "Appendix on drug stability test guidelines. Country Food Drug Administration issued 13 orders direct contact with packaging material and container management practices, "and the recently issued 24 new drugs instructions and orders Label Regulations "and other regulations is to standardize management of drugs within and outside the packaging, to ensure drug quality and safety of the public administration.
Drugs and drug packaging materials including packaging materials within the direct contact and direct or indirect contact with drugs Packaging Printing Material.
Direct contact with drugs within the packaging material. If you choose wrong. Could absorb the active ingredient in medicines. Reduce the effective ingredients affect the efficacy of drugs. Some within the packaging material can also migrate to the drugs, the release of toxic and hazardous substances. Some materials may even lead to accelerated degradation of drugs. Not only affects the efficacy of clinical use of drugs. To the public administration will bring about serious safety problems.
Drugs for the direct or indirect contact with the packaging and printing materials, such as sales of each drug package instructions, drug labels, Box (Can be regarded as a special form of tags) and so on. Because of its content and the public with information closely related to drug safety. To this end the current Drug Registration "requirement. Pharmaceutical packaging and printing materials during registration. Similarly, drug regulatory authorities to obtain approval. Modify the packaging and printing materials related to the content. Drug regulatory department to add applications. The approval or permission for the record before implementation.
For direct contact with the packaging material or container. Drug manufacturers must be based on the Chinese Pharmacopoeia appendix on drug stability test guidelines. And the State Food and Drug Administration trial standard YBBO0142002 drug packaging materials and drug compatibility testing guidelines. " According to the results printed on the packaging of pharmaceutical packaging production rigorous review, select the appropriate packaging and packaging materials. And to drugs registered. Together with the application. Determine their choice of packaging and packaging materials.
Pharmaceutical packaging. As an important information carrier. Safety of the public administration must provide the necessary information.
State current Law Regulations on pharmaceutical packaging and printing must contain content, including drugs General Name, composition, specifications, indications, dosage, adverse reactions, contraindications, precautions, drug use in elderly patients medication of children, pregnant or lactating women, drug use, drug interactions, drug overdose, drug toxicity, and expiration date and other information were strictly requirements. This information is closely related to drugs and public safety. For this reason, pharmaceutical manufacturers, drug packaging and printing companies should join hands to actively set up and improved drug safety mechanism to ensure the public to provide accurate and comprehensive drug information.
Pharmaceutical Packaging: The First Hurdle To Ensure Drug Safety
