Process Validation Lifecycle Approach: Challenges ... AWS
Process Validation Lifecycle Approach Challenges, opportunities, and questions that will shape the next decade
1. Can we employ true risk and science based thinking? The Line of Sight approach, only validating all that is necessary.
Line of Sight Validation and Process Control Define product
What is critical?
Design process
How is achieved?
Identify variables
What could go wrong?
Control strategy
Mitigate the risk
Qualify process
Prove the process is capable.
Validation
Commercial production
Run the process and learn
Scientific approach to number of batches
Meets higher level of C2 (99/99 or 95/99.9)
Meets C2 (95/99,eetc)
Meets lower Confid nce of C2 ( 90/99)
N=3
+
• Number of batches is not an acceptance criteria
• Results of data are the acceptance criteria, but batches provide the data • Acceptance criteria aligned with objective of study, based on confidence you wish to achieve and the data you already have • Statistical sampling is only one tool you have to provide confidence
Attribute Severity
Ppk < 1.0
1.0 ≤ Ppk < 1.5
High
Investigation
Investigation
SME and QA
Medium
Investigation
SME and QA
Close out By SME
Low
SME and QA
Close out By SME
Ppk > 1.5
• Prior knowledge, process robustness, and scientific principles may also be used • Science gives us severity, confidence and coverage
• Statistics gives us occurrence rates and helps define # of samples
Close out By SME
2.
Are traditional process validation and control methods the best approach for new technologies and therapies? Critical thinking and the need for change. How would you define “validation” batches in a continuous manufacturing process?
3.
How will product cost, affordability, and availability effect process validation approaches? The pragmatism of public health. If drug shortages pose a real threat to public health, then should companies be required to “validate” robustness of manufacturing systems?
4. Will the global regulatory environment result in harmonization or redundancy? The value of science, language, and clarity
If the science is the same, then shouldn’t the requirement be the same?
5.
How can process validation help drive process improvement? The realization that improvement is possible and necessary. Should PAC take into account potential process improvements, uncovered in Stage 3?
6.
What effect will the availability of knowledge have on process validation? The benefits and challenge of data exactness, interpretation, and integrity.
Will current expectations and methods for computer system validation dissuade the use of big data, cloud based systems, interconnectability, and data sharing or help provide valuable scientific information?
7. What is the vision of the future? Avoiding the stagnation of complacency. One can curse the darkness or light a candle. Which will it be?
Thank you … Hal Baseman ValSource LLC [email protected] 1.561.676.3940
1. Can we employ true risk and science based thinking? The Line of Sight approach, only validating all that is necessary.
Line of Sight Validation and Process Control Define product
What is critical?
Design process
How is achieved?
Identify variables
What could go wrong?
Control strategy
Mitigate the risk
Qualify process
Prove the process is capable.
Validation
Commercial production
Run the process and learn
Scientific approach to number of batches
Meets higher level of C2 (99/99 or 95/99.9)
Meets C2 (95/99,eetc)
Meets lower Confid nce of C2 ( 90/99)
N=3
+
• Number of batches is not an acceptance criteria
• Results of data are the acceptance criteria, but batches provide the data • Acceptance criteria aligned with objective of study, based on confidence you wish to achieve and the data you already have • Statistical sampling is only one tool you have to provide confidence
Attribute Severity
Ppk < 1.0
1.0 ≤ Ppk < 1.5
High
Investigation
Investigation
SME and QA
Medium
Investigation
SME and QA
Close out By SME
Low
SME and QA
Close out By SME
Ppk > 1.5
• Prior knowledge, process robustness, and scientific principles may also be used • Science gives us severity, confidence and coverage
• Statistics gives us occurrence rates and helps define # of samples
Close out By SME
2.
Are traditional process validation and control methods the best approach for new technologies and therapies? Critical thinking and the need for change. How would you define “validation” batches in a continuous manufacturing process?
3.
How will product cost, affordability, and availability effect process validation approaches? The pragmatism of public health. If drug shortages pose a real threat to public health, then should companies be required to “validate” robustness of manufacturing systems?
4. Will the global regulatory environment result in harmonization or redundancy? The value of science, language, and clarity
If the science is the same, then shouldn’t the requirement be the same?
5.
How can process validation help drive process improvement? The realization that improvement is possible and necessary. Should PAC take into account potential process improvements, uncovered in Stage 3?
6.
What effect will the availability of knowledge have on process validation? The benefits and challenge of data exactness, interpretation, and integrity.
Will current expectations and methods for computer system validation dissuade the use of big data, cloud based systems, interconnectability, and data sharing or help provide valuable scientific information?
7. What is the vision of the future? Avoiding the stagnation of complacency. One can curse the darkness or light a candle. Which will it be?
Thank you … Hal Baseman ValSource LLC [email protected] 1.561.676.3940
