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Part 1 of this two part blog series, gave a high-level overview of the new ICH guideline Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. In part 2 of this blog series, some of the key takeaways will be discussed in more detail. Q12 is intended to help companies demonstrate increased product and process knowledge, and understand which post-approval changes will require a regulatory submission, as well as the level of reporting for each category.
Q12 leverages earlier guidelines, such as ICH Q8 (R2), ICH Q9, and ICH Q10. These form the fundamental concepts of QbD (quality by design). They cover the need for: (a) improved product and process understanding; (b) application of risk management; and (c) an effective PQS (pharmaceutical quality system).
Q12 discusses eight different concepts:
Effective knowledge management systems and cross functional risk assessments form the foundation of the ability to gain the benefits conveyed through Q12. For a drug product, or a drug-device combination product, deep product and process understanding (that results from a properly designed and documented development process) provides the opportunity to leverage the concepts presented in Q12, such as PACMP and PLCM documents. One of the key characteristics to understand will be what determines ECs; this is binding information considered necessary to assure product quality. For example, EPR’s (essential performance requirements) of a combination product would be considered ECs.
This is only a small taste of the many topics presented in Q12 – a new guidance to reinforce the importance of lifecycle management with any new drug or combination product.
Check out Part 1 for an overview on this guideline and for more on how West can help understand and navigate this, and other regulations, contact an Account Manger or Technical Customer Support (TCS) representative.
Diane Paskiet, Director, Scientific Affairs, will present at two sessions during the <strong>2012 PDA Annual Meeting. The meeting will be held from April 16-18, 2012 at the JW Marriott Desert Ridge Resort in Phoenix, Arizona.</strong>
<span>Manufacturers of parental drug package/delivery systems must be up-to-date on the ever-changing regulatory landscape. At Pharmapack 2017, Fran DeGrazio, Vice-President of Scientific Affairs and Technical Services, spoke on the topic of metal impurities in a presentation entitled: <em><span>The Changing Regulatory Environment Concerning Elemental Impurities and Container Closure Systems</span></em></span><em><span>. </span></em><br>
Electron-beam irradiation (<em>e-beam </em>- sometimes called beta irradiation) is a technique used commonly to sterilize pharmaceutical packaging products and medical devices. It operates by directing a continuous flow of electrons through the articles being sterilized. Transfer of energy from the e-beam breaks the chains of DNA in organisms, rendering them inactive, and the articles irradiated as sterile. It is used typically for Ready-to-Use (RU) vials and syringes comprising Daikyo Crystal Zenith® cyclic olefin polymer, and Daikyo PLASCAP® seal products.
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.
As we celebrate our 240<sup>th</sup> Independence Day, we would like to take a moment to express our appreciation to veterans and their families who serve to help keep America safe and to those who came before them in this noble cause.
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