
- BioPharm International-09-01-2016
- Volume 29
- Issue 9
PDA Issues Call to Action for Faster Postapproval Changes
The Parenteral Drug Association develops program to address barriers to implementation of postapproval changes.
The Parenteral Drug Association (PDA) has announced its
PACs may result from a response to regulatory requirements, a company’s desire to improve manufacturing and/or analytical processes, risk management, or advances in innovation. Global regulations imposed on product-related PACs can impact the supply of effective drugs as varied global regulatory processes can make implementation of PACs complex and difficult. PDA is hoping their program can help streamline the complex global PAC environment and address some of the challenges manufacturers face.
The PAC iAM Program will identify, assess, and address current barriers to implementation of PACs. PDA is planning on publishing science- and risk-based approaches to lifecycle management. The association will also create templates for standardized global postapproval change management protocols (PACMPs) for specific changes to manufacturing processes and analytical technologies and establish a library of real-world examples of best practices for PACs using a science- and risk-based approach. Forums to encourage collaboration and open dialog between stakeholders in healthcare are planned.
PDA is looking for volunteers with experience in postapproval changes to help with the development of a technical report. Those wishing to participate can contact PDA’s Science and Regulatory Affairs at
Source:
Articles in this issue
about 9 years ago
Parenteral Advisory: Outmoded Fill/Finish Technologyabout 9 years ago
Analyzer Automates Cell-Culture Chemistry Analysisabout 9 years ago
Data Logger Provides Ultra-Low Temperature Readingsabout 9 years ago
Manufacturing and Distribution Boundaries Blurabout 9 years ago
Modeling Bioreactor Performanceabout 9 years ago
Implementing a Dual Approach to Protein Characterizationabout 9 years ago
Efforts Accelerate to Streamline Postapproval Change ProcessNewsletter
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