Industry One-Voice-of-Quality (1VQ)
on Post Approval Changes (PACs)
Ideally:
One product for one world
Reality:
One product with 100+ approvals
Closer to real-time post-approval change management
to reduce drug shortages and enhance continual improvement and innovation
Post-approval changes are inevitable and necessary throughout the life of a drug product – to implement new knowledge, maintain a state of control, and drive continual improvement.
Due to the global complexity, individual PACs often take years for full worldwide approval, even when they reduce patient risk, improve compliance, and/or enhance processes or methods. This can ultimately lead to potential drug shortages for patients and possible compliance risks for companies.
Chief Quality Officers of 20+ global pharmaceutical companies are speaking with “One-Voice-Of-Quality” to offer solutions that will greatly reduce PAC complexity with no added risk to patient safety.
1VQ Objective
Identify, assess and address current barriers to implementation of post approval changes that are intended to ensure continued (un-interrupted) operations, drive innovation and continual improvement in a maximally efficient, agile, flexible Pharmaceutical manufacturing sector.
Addressing these barriers will better ensure and sustain reliable global supply and availability of high-quality product to patients through the entire commercial lifecycle of a product without extensive regulatory oversight.
We invite you to join the dialog, share your thoughts, successes or suggest PAC examples
to align the industry on, at 1VQ@prst.ie
Regulatory Guidances
- ICH Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
- ICH Q10, Pharmaceutical Quality System
- ICH Q10 Concept Paper
- ICH Q9, Quality Risk Management
- Draft PIC/S Recommendation on How to Evaluate / Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management
- Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use During the Covid-19 Pandemic
- Guidance for Industry: Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products
Other Relevant Publications
- PDA Technical Report 68: Risk-Based Approach for Prevention and Management of Drug Shortages
- PDA PAC iAM 2017 Survey on Post-Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry
- Drug Shortage is a “Wicked Problem”
- Continual Improvement While Maintaining A State of Control: A Concealed Paradox or a Mutual Interdependence?
- Demonstrating Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction
- PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities
- PQS: An Effective Lever for Managing PACs
- Creating a Global Incentive for Pharma: A Roadmap to Avoid Drug Shortages
Emma Ramnarine
1VQ Co-Lead
Global Head, External Development Collaborations
Genentech/Roche
Anders Vinther
1VQ Co-Lead
VP, Global Head Technical Operations
Intarcia Therapeutics