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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.