We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
Technical Guideline for Study of Nitrosamine Impurities in Chemical Drugs (Trial) was issued by the China National Medical Products Administration on 8 May 2020. This guideline discusses nitrosamine impurities in drug products, including the sources of nitrosamine impurities and the control strategy. The control strategy is given from the perspectives of the basic concept of control, control limits, establishment of analytical methods, and control of risk throughout the drug product lifecycle.
As nitrosamines are known as probable carcinogens, the marketing authorization holders and drug manufactures should take the responsibility to evaluate the risk by performing nitrosamine testing of API, excipients, and package system through the drug product shelf life using globally recognized test methods. The nitrosamine impurities level should be controlled below the acceptable limits based on compliance with ICH M7 (R1) [Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk] requirements.
As the world leader in the integrated containment and delivery of injectable medicines, West is well aware of the guidance concerning nitrosamines. Additionally, West closely monitors this issue and works to fully support customers with relevant information. For more regarding nitrosamine data in formulations, please contact a technical customer support (TCS) representative.
As members of the pharmaceutical community, we’re often keenly aware of regional regulatory differences. But it’s just as useful to focus on points of harmony, whether these are well-established, emerging, or implicit in regulatory and industry feedback.
West recognizes its responsibility to operate with integrity and to proactively identify potential misconduct. We hold ourselves accountable to the highest standards of quality, integrity and respect for our team members, our shareholders, our customers, and the patients we jointly serve.
Cartridge-based administration using injection device systems has dominated the insulin market for many years. In 2011, the insulin market for cartridge-based container closure systems was at an estimated 1 billion units. Additional applications for cartridge-based container systems include dental, at more than 450 million units per year, and therapies such as human growth hormone, interferon and epinephrine. In fact, thanks to lower production costs when compared to vial and syringe systems, cartridge-based delivery has found a widespread and growing market.
The Global Technical Customer Support (TCS) team has as its main focus engagement with customers – facilitating access to West’s expertise in pharmaceutical packaging components and delivery solutions, and providing assistance and technical information on West and Daikyo products and services.
<p>Both the FDA and Health Canada have issued guidances to industry that require Drug Master Files (DMFs) to be provided in electronic formats by defined deadlines.</p>
English
Chinese
