Many companies already have a risk based change notification program. The goal of this effort has been to develop a standardized way of making and reviewing risk assessments for change notifications.
For this standardized approach to benefit the industry it is important that participating companies implement elements of the program in a defined manor defined so that companies know when they have implemented the practice. The overall aim has been to make implementation meaningful but not onerous.
There are currently four aspects of the practice that companies are being asked to implement, these are
- Use of the decision tree and supporting principles in categorizing changes
- Use of Single Points of Contact for change notifications (SPOC)
- Commitment to completing the scorecard survey annually to monitor the impact this way of working is having
- Use of the guidelines on data package quality to deliver right first time data packages (once available).
The tools the team have developed are designed to promote critical thinking and better understanding and alignment of risk between biomanufacturers and supply partners within the biopharmaceutical single use industry.
It is not possible to cover every eventuality and technology that may be encountered and consequently several of the tools are not prescriptive. The intention is also for the community to continue to evolve processes and ways of working to achieve the desired state.
Conversely, as this practice is intended to provide a common way of working for the industry, establishing trust in the methodology and in its application across companies is critical. To that end there must be some standardization of approach and implementation across companies for the best practice to be valuable and impactful. The team has looked at each element of the practice and have agreed what constitutes implementation. Once a company has met these conditions, they can consider that element of the practice implemented.
|Item||End User||Supply Partner|
|Decision Tree Implement||What is Implementation for the End User?|
1. Recognition of the BPOG/BPSA Change Notification categorisation
2. Alignment of categorisation (as far as possible)
3. Notify supply base of the recognition of the BPOG/BPSA Change Notification categorisation
• Develop a plan to allow practices and procedures for change notification to recognize the BPOG/BPSA Change Notification categorization, which will require input from Stakeholders
• The Stakeholder Map provides a tool to help identify who within your organization needs to be aware of the BPOG/BPSA Change Notification Best Practices and Decision tree tool
• Review your plan with your BPOG L2 with the aim of securing organizational sponsorship for the plan from your L2 or L1
• For 1 & 2 above: Revision of procedures to document recognition of the BPOG/BPSA Change Notification categorisation and guide practices
• For 3 above: Use the end user letter template and/or new supplier agreements
• Commit to providing feedback to improve the decision tree
|• Use the stakeholder map or other tool to identify who within your organization needs to be engaged with implementation.
• Get commitment to begin to use the BPOG/BPSA Decision Tree to determine the level of change that you will assign to an SUS change.
• Develop a plan to update any training, procedures and practices to reflect this.
• Review this plan with your L2 and secure organizational sponsorship via your L2 or L1 for the implementation.
• Commit to indicating which level of change you assign to a given change within your notifications.
• Use the supplier template letter (or similar)Inform your customer base that you will be notifying change levels based on the BPOG/BPSA Change Notification Best Practices Paper and decision tree.
• Commit to providing feedback for the improvement of the decision tree.
|Scorecard Implement||• Commit to completing the scorecard survey annually in Q3. Provide output to BPOG for blinding and aggregating into an industry overview.||• Commit to completing the scorecard survey annually in Q3. Provide output to BPOG for blinding and aggregating into an industry overview.|
|SPOC||We encourage the adoption of a single point of contact e-mail address. Further detail Coming Soon||We encourage the adoption of a single point of contact e-mail address. Further detail Coming Soon|
|Data Package Quality||Data package recommendations to be published soon. Actions to implement will be updated once available||Data package recommendations to be published soon. Actions to implement will be updated once available|