Abstract
The complexity of the current pharma market needs the most effective drug product development and production. Product lifecycle management (PLM) can produce pharmaceutical manufacturing more efficiently and with less risk. The life cycle approach became adopted in numerous stages within the pharmaceutical company, considering its inception. This International Council for Harmonisation (ICH) Q12 guideline intends to enhance the supervision of the post-approval chemistry, manufacturing, and control changes most reliably and effectively both for pharmaceutical industries and regulatory authorities. In this review article, we discuss the benefits and challenges related to this enhanced framework. The new ICH Q12 guideline “Technical and regulatory considerations for pharmaceutical product lifecycle management” assist the management of post-approval chemistry, manufacturing, and controls (CMC) changes in an effective way with regard to the pharmaceutical companies.
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