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ICH (International Council for Harmonization) recently adopted (1 Nov 2019) the guideline Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. This guideline includes two annexes and aims to “promote innovation and continued improvement in the pharmaceutical sector”.
Change is a natural occurrence over lifecycle due to evolving knowledge, improved understanding about processes and systems, and efforts on continuous improvement. Q12 is focused on the commercial phase of the lifecycle of a drug substance, drug product, and drug-device combination product. The FDA is encouraging use of Q12, as it is compatible with their legal framework. Moreover, Q12 allows flexibility for post-approval CMC (chemistry, manufacturing, controls) changes based upon the effectiveness of a company’s PQS (pharmaceutical quality system) and risked-based change management system. The extent of this flexibility depends on several factors: (a) amount of product and process understanding;, (b) application of QRM (quality risk management) principles;, and (c) effective quality system (ICH Q8 (R2), ICH Q9, ICH Q10 and ICH Q11).
Some of the key new concepts introduced are:
Leveraging Q12 is an excellent way to better explain to regulatory agencies the understanding of greatest risks and the ongoing management of a product through its lifecycle. Note that in Europe rework of some local regulations must be performed in order to fully implement some of the concepts of Q12.
Click here to read the Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.
Part 2 will consider some of the key new concepts of Q12 in more detail.
<p><strong>J. Riter, A. Janssen, D. Engels</strong></p><p>Cracking of elastomeric needle shields and tip caps is a costly problem for pharmaceutical manufacturers. Cracked components can cause leaks that can result in loss of drug potency and sterility and may lead to a safety risk for the person administering the drug and the patient. This cracking has been attributed to ozone degradation of the elastomer formulations.</p>
Understanding the different compendial and standards requirements, and how they influence the final delivery of parenteral drug products, is critical for ensuring patient safety. There are ongoing efforts to harmonize national pharmacopoeia and international standards, driven in large measure by the continuous technological developments in the pharmaceutical industry. Harmonization efforts can be treated differently depending upon the country and working group, and in some cases larger differences result. Staying aware of changes and differences can be a challenge.
Want to learn more about quality planning for injectable delivery systems? Join West’s technical experts on April 24, 2012 at the Renaissance Raleigh North Hills Hotel for a free educational seminar.
<p><em>Dr. Heike Kofler, Amy Miller, Jennifer Riter<br /></em><em>West Pharmaceutical Services, Inc.</em></p><p>One of the critical success factors for packaging lyophilized drugs is protection against product degradation caused by moisture. Moisture can be introduced into a lyophilized drug product cake from the elastomeric stopper and from the atmospheric headspace; it can also permeate through the stopper, a process known as moisture transmission.</p>
We are pleased to announce our recent publication in the November/December 2019 Issue of the International Journal of Pharmaceutical Compounding. In the article “How to Qualify Container Closure Systems, Part 1,” we address how compounding pharmacies (503Bs) can qualify systems for intended use via container closure integrity (CCI) to meet FDA Guidance requirements.<sup>1</sup>
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