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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.
ICH (International Council for Harmonization) recently adopted (1 Nov 2019) the guideline <em>Q12</em> <em>Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management</em>. This guideline includes two annexes and aims to “promote innovation and continued improvement in the pharmaceutical sector”.
Are you challenged with managing change as it relates to a drug substance, drug product or drug/device combination product? You are not alone!
There are clear gaps in understanding in the market of combination products. A major one was highlighted at a recent workshop sponsored by West. A survey showed that <em>over 20% of attendees were not aware of the considerations needed to build a control strategy. </em>
A new regulatory guidance in the US has clarified expectations for pharmaceutical companies wishing to transition from an existing pharmaceutical component wash process to another, such as the Westar<sup>®</sup> Ready-to-Sterilize (RS) process.
Do you want to better understand how to navigate the regulatory pathway to successfully bring a drug/device combination product (CP) to market? Understanding that many have this question, West, in collaboration with the Delaware Valley Chapter of PDA, sponsored the symposium (Sep 23): <em>The Evolving Landscape for Combination Products – Defining a Regulatory Strategy</em>. Experts from the industry and the FDA presented and discussed the latest best practices.
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