Speed with Safeguards: Agile TPM for CMC in Fast-Track and Breakthrough Programs

Pawankumar Suresh

doi:10.5281/zenodo.17205242

Speed with Safeguards: Agile TPM for CMC in Fast-Track and Breakthrough Programs

Author(s)	Pawankumar Suresh
Country	India
Abstract	The fast track and breakthrough programs of biopharmaceutical development accompanied by the need to accelerate the CMC (chemistry, manufacturing and controls) steps of the CMC process while maintaining compliance is a challenge today. CMC processes need to be performed efficiently, and industry standards and practices need to incorporate processes and controls in place for rapid health care changes, all without regulatory noncompliance. Conventional project management approaches lack the ability to integrate the finesse and balanced approach needed to attend to the GxP (good practice) documentation requirements, quality, and speed of the regulated project. Perfect CMC has developed a framework for 'Agile' Technical Project Management (TPM) for CMC programs. Sprints, stand-ups, and retrospectives with Agile tools combined with regulatory 'form' driven requirements. The developing framework 'Speed with Safeguards' is defined as the combination of monitoring and control of a process and documentation without undue regulatory compliance burdens. Agile approaches also foster rapid assessment and responsive controls for development. Providing the documentation, and regulatory compliance, as well as the process control, assures the measurable development 'uncertainties' are contained. Tools of collaboration, elastic compliance technologies, and smart compliance with regulatory requirements permit CMC teams to achieve operational resilience. increased dependability of regulatory filings,reduced risk and operational resilience are achieved. Evidence and case studies affirm this combined approach does result in faster decision processes, enhanced compliance processes, and fosters non-siloed innovation. Organizations adopting this model achieve a balanced approach in the tension between control and compliance. Cross border permit faster access to therapies for patients without compromising quality control. Offered documentation keeps real-time indicators for compliance non-intrusive.
Keywords	Agile, Technical Project Management, CMC, Fast-Track Development, Breakthrough Programs, GxP Compliance, Safeguarding, Documentation Integrity, Regulatory Submissions, Digital Transformation.
Field	Medical / Pharmacy
Published In	Volume 4, Issue 3, March 2023
Published On	2023-03-11
Cite This	Speed with Safeguards: Agile TPM for CMC in Fast-Track and Breakthrough Programs - Pawankumar Suresh - IJLRP Volume 4, Issue 3, March 2023. DOI 10.5281/zenodo.17205242
DOI	https://doi.org/10.5281/zenodo.17205242
Short DOI	https://doi.org/g943nn

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Speed with Safeguards: Agile TPM for CMC in Fast-Track and Breakthrough Programs

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