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您的位置:首页 >> 资讯 >> 行业访谈 >> 专家采访—— 恩福(上海)检测技术有限公司 James R.Scull,PH.D

专家采访—— 恩福(上海)检测技术有限公司 James R.Scull,PH.D

http://www.cphi.cn   2016-07-26 11:48 来源:CPhI制药在线

6月24日,CPhI制药在线记者专访NSF International 在上海的独资实验室——恩福(上海)检测技术有限公司的James R.Scull,PH.D。Dr Scull为我们解读了目前美国和欧盟地区的最新医疗器械法规和药品包装材料相关行业的法规要求;药包企业在申请毒理学评估时应注意哪些方面等。

       全球公共卫生和安全组织NSF International,主要进行美国的国家标准撰写, 并对健康科学、食品、水、日用消费品和可持续发展等行业的产品提供检测和认证服务。美国生命科学部门下属GLP/GMP实验室拥有近20年的药品包装检测及药品包装相容性研究经验,是美国FDA官方注册实验室。可以为国内外客户提供用于FDA国际注册的药包相容性研究服务实验室。 恩福(上海)检测技术有限公司,是NSF International 在上海的独资实验室。在国内外技术专家的指导及大力支持下,自2013年以来从事药包相容性研究,为多家国内药厂在中国和美国的药品注册提供服务。NSF上海实验室装备有先进的检测分析仪器,(ICP-MS,LC-MS/MS,GC-MS/MS等)确保实验方法的灵敏度和精密度,研究和检测数据真实可靠值得信赖。

 

       1) The most updated US. and European regulatory requirements on the medical devices and pharmaceutical packaging industry;

       您能谈谈目前美国和欧盟地区的最新医疗器械法规和药品包装材料相关行业的法规要求吗?

       Most people working with extractables&leachables are aware of the PQRI Best practices document for inhalation drug products from 2006. Most recently, the PQRI has issued another best practices document for parenteral products. Additionally, in the United States, the US Pharmacopeia (USP) has recently revised Chapter <661> to mimic the testing of the PQRI best practices, making such testing a legal requirement. The USP has also issued related chapters <1661> and <1663> that specifically relate to the testing of the materials of construction and leachables assessment of drug packaging components.

       很多从事提取物和浸出物研究的行业人士都清楚药品质量研究学会(PQRI)2016年发布的关于吸入式药物的最佳操作规范文件。最近,药品质量研究学会发布了另外一份注射给药药物的最佳操作规范文件。此外,在美国,《美国药典》(USP)近期修订了第<661>章, 要求对药品进行PQRI最佳操作规范的测试,从而使得该测试成为正式的法规要求。《美国药典》还颁布了相关的章节<1661>和<1663>,这两个章节具体涉及到结构材料的测试和药品包装组件的浸出物评估。

       The FDA has also issued a guideline for infusion medical devices that highly recommends that any part of an infusion device, that contacts the drug or the patient, be tested for extractables, leachables and drug compatibility.

       美国食品与药物管理局(FDA)同样颁布了关于注射医疗器材的指导原则,强烈建议任何接触到药品或病人的输液器材都应进行提取物、浸出物和药物相容性的检测。

       In Europe, the new medical device directives closely match those of the USA and may require additional testing based on the newly proposed reclassification of some medical devices.

       在欧洲,新的医疗器材指令与FDA的这些要求非常类似,并可能根据最新提议的某些医疗器材的重新分类要求进行额外的测试。

       2) The safety of Pharma Packaging and medical devices got extensive attention in foreign countries. How can NSF International help companies to ensure the safety of pharma packaging products? What kind of research and studies are conducted by NSF usually?

       药品包材及医疗器械的安全性在海外也是深受关注的问题,请问NSF International是如何在海外帮助药包企业确保包材的安全性?通常会进行一些什么研究及措施?

       Every major geography, be it Europe, China, South America or the USA have some set of regulations or expectations for ensuring the safety of pharmaceutical packaging. To ensure that NSF is at the forefront of thought leadership in this area, we have several experts on staff who participate in the USP, PQRI, MHRA and Brazilian committees. These NSF personnel serve as key members of these committees to drive consistency in best practices applications around the world.

       在各个主要国家和地区,如欧洲、中国、南美或者美国,都有一系列法规或要求来确保药品包装材料的安全。为保证NSF在该领域的领导地位,我们的数位专家都加入了《美国药典》(USP)、药品质量研究协会(PQRI)、英国药品和健康产品管理局(MHRA)和巴西医药委员会。NSF的专家们作为这些协会中的重要会员,致力于推动全球范围内最佳操作规范应用方面的一致性。

       NSF conducts a wide variety of research in extractables&leachables. Not only for inhalation and injectable drug packaging, but also for infusion devices, implantable devices such as cardiac stents, transdermal products as well as bioreactors and manufacturing equipment. While the testing across this broad range is similar, the regulatory expectations are different. NSF experts are very knowledgeable in all of the applicable regulations.

       NSF专注于广泛多样的提取物和浸出物研究。研究不仅涉及吸入和注射给药药物的包装材料,还包括输液器材、移植器材,例如心脏支架、透皮给药产品以及生物反应器和其它制造设备。虽然在这个大范围内的测试基本是类似的,但是在具体的监管法规要求方面还是有所差异的。NSF的专家们熟知所有的应用法规要求。

       3) As we all know that NSF has more than 20 years experiences in US pharmaceutical industry. Based on the long-term cooperation relationship and understanding with US pharma companies, could you please tell us how NSF understand the basic principles when U.S. pharma companies choose qualified packaging suppliers? How can NSF help companies to regulate the principles?

       我们都知道NSF在美国药品领域拥有超过20年的研究经验。基于NSF International与美国药企的长期合作和了解,NSF能否解读美国药企选择合格的药包材供应商的基本原则?NSF如何帮助药企把控这些原则?

       Management of the pharmaceutical supply chain is the most important and the most challenging work in the industry today. Many companies truly have a global supply chain and distribution network. For packaging, it involves plastic and resin suppliers, additive manufacturers, compounders and molders, as well as carton, label, ink and adhesive suppliers. Choosing reliable and qualified suppliers and back-up suppliers, is critical to maintaining a quality supply chain operation.

       管理药品供应链是现今行业中最重要和最具挑战性的工作。很多企业都有全球性的供应链和分销网络。对于包装行业而言,它涉及到塑料和树脂供应商、添加剂制造商、复合生产商和模具商,以及纸箱、标签、油墨和粘胶剂供应商。选择可以信赖和合格的供应商以及后备供应商,对于维护一个优质供应链运营来说是非常重要的。

       NSF helps companies with supply chain management by evaluating the risk levels across the entire chain, then mitigating those risks through implementation of supplier agreements and routine quality control testing and audits. NSF also helps the suppliers to anticipate industry trends and requirements and provides a "Vendor of Choice" program designed to align quality suppliers with end-user pharmaceutical companies.

       NSF可以帮助企业进行供应链管理,主要通过评估整个供应链的风险等级,然后实施供应商协议和日常质量控制检测和审核等措施来减少这些风险。NSF还能帮助供应商预期行业发展趋势和要求,并提供符合优质供应商和终端药企要求的"供应商选择"方案。

       4) Toxicological assessment is an important link in packaging compatibility study. Would you please introduce your views on toxicological assessment briefly?

       我们都知道毒理学评估在包材相容性研究中是至关重要的一环。能否简单聊一下您对毒理学评估的一些看法么?

       The ultimate goal is to deliver a safe and effective product to the patient. The nature of pharmaceutical packaging is one of active chemistry. All of the plastic components have some type of additive package to prevent deterioration and maintain the integrity of the packaging. These additives and other small molecules, may leach into the drug product over time. The importance of the toxicological risk assessment is to ensure that these leachables do not adversely affect the stability or efficacy of the drug product.

       我们的终极目标是把安全的和有效的产品给带给病人。药品包装的本质是一门活跃的化学学科。所有的塑料组件都含有某种添加剂,用于阻止退化并保持包装材料的完整性。这些添加剂和其它一些小分子,可能会随着时间的推移而析出到药品中。毒理学风险评估的重要性是为了确保这些浸出物不会对药品的稳定性和有效性产生负面影响。

       5) What should the pharma packaging companies pay attention to when they apply for toxicological assessment?

       药包企业在申请毒理学评估时应注意哪些方面?

       They must understand that these assessments are performed by highly skilled and educated people. There is a great depth of literature review, research and expert interpretation that is involved in developing a proper risk assessment. In many cases, more than 50 literature articles must be reviewed for just a single compound. This takes many hours and the final compiled report is very comprehensive. Ultimately, the toxicologist conducting the assessment is taking personal responsibility for the interpretation and conclusions. Therefore, the expert's reputation is also part of the final product. It is important to select a toxicologist who has many years of conducting these assessments and arriving at conclusions that are defendable to regulatory authorities.

       企业必须清楚这些评估是由非常专业的和高端技术人员操作的。涉及到研发出一个适合的风险评估方案的文献资料评审、研究和专业解读需要很深的造诣。在大多数情况下,仅一个化合物就需要审查50多个文献资料。这些工作需要花费很多时间并且最终的编制报告也是非常专业和全面的。基本上,毒理学家进行评估时需要对自己做出的解释和结论负责。因此,专家的名誉也是成品的一部分。很重要的一点是,企业需要选择一个具有多年评估从业经验并且其做出的结论对监管当局来说是可控的毒理学家。

    

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