FDA Guidance on ICH Q12 Will Accelerate BioPharma PLM Adoption

As Bio-Pharmaceutical companies look for opportunities to accelerate innovation cycles, the management of products across the complete lifecycle to support continuous improvement is a strategic imperative.  To fast-track innovation, companies need to be open to new ideas and have awareness of new and emerging systems and technologies. 

This week, FDA issued guidance supporting the use of ICH Q12 to encourage the use of Product Lifecycle Management across the Pharmaceutical.

This globally harmonized guideline builds upon the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). These guidelines to provide a framework on the technical and regulatory considerations for Bio-Pharmaceutical product lifecycle management.  Through Q12, global regulators intend to promote innovation and continuous improvement in the bio-pharmaceutical sector, strengthening quality assurance and improving the supply of medical products.

While most Bio-Pharma companies have complex stage-gate product development and change management and investigation processes, they lack the ability to connect decision loops across the total product lifecycle.  Or stated another way:   They lack a harmonized, integrated and closed loop approach to product lifecycle management (PLM).  As a result, they are often unable to easily manage and respond to post-approval issues resulting from product, supplier or process changes as well as customer inquiries, adverse events and regulatory findings.  Consequently, there is an inconsistent utilization of post-approval change management processes to improve products and processes. 

In Brief:

The lack of a comprehensive product lifecycle management system – that is inclusive of both product and process and all related resources including upstream research & development intelligence – has hindered innovation and continuous improvement in Bio-Pharma. 

As Bio-Pharma companies look for opportunities to accelerate innovation cycles to support continuous improvement, a fully integrated platform that enables innovation and support ICH-Q12 could be the key to Bio-Pharma Digital Transformation.

FDA’s Guidance on ICH Q12 will accelerate the adoption of recipe based PLM in Bio-Pharma

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