APR Sept/Oct 2023 - 106

MANUFACTURING
documentation of quality assurance delivered by the manufacturer.
Innovation in development, manufacturing and quality assurance that
leverages process analytical technology should help answer these
common regulatory questions from FDA experts:7
* What are the mechanisms of degradation, drug release,
and absorption?
* What are the effects of product components on quality?
* What sources of variability are critical?
* How does the process manage variability?
Regulatory Submission
Regulatory considerations that can help document quality assurance
improvements from process analytical technology often are found in:
* Reducing production cycle times by using on-, in-, and/or atline
measurements and controls
* Preventing rejects, scrap, and re-processing
* Real time release
*
*
* How quality attributes can be accurately and
reliably predicted
This type of regulatory documentation provides insights for FDA
regulators into materials used, an understanding of process parameters,
changes in manufacturing, and environmental conditions.
The ability to predict these three items can show a high degree of
process understanding. The goal is for your regulatory application to
demonstrate your team and company understands how to reproduce
process capability data and maintain a consistent state of control.
Conclusion
Increasing automation to improve operator safety and reduce
human errors
Improving energy and material use and increasing capacity
* Facilitating continuous processing to improve efficiency and
manage variability
Regulatory Documentation
Quality assurance improvements are centered around the
manufacturing process and system processes involved. FDA considers
a process to be well understood if regulatory documentation shows:8
* Why sources of variability can be identified and explained
* When production variability can be managed by owners of
the process
106
American Pharmaceutical Review | September/October 2023
References
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https://www.fda.gov/media/71012/download
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/
pharmaceutical-quality-21st-century-risk-based-approach-progress-report
https://www.fda.gov/media/71012/download
https://www.fda.gov/media/71012/download
https://www.fda.gov/media/71012/download
https://www.fda.gov/media/71012/download
https://www.fda.gov/media/71012/download
https://www.fda.gov/media/71012/download
Process analytical technology is used to improve the scientific basis
for regulatory specifications and promoting continuous improvement.
The ability to enhance manufacturing while retaining or improving
product quality is essential to helping patients and population health
in general. Life science manufacturers should document technology
improvements to FDA and demonstrate the ability to quickly resolve
production-related technical issues.
For more insight about how RCA can support your team, please visit us
online at www.rcainc.com.

http://www.rcainc.com https://www.fda.gov/media/71012/download https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/ https://www.fda.gov/media/71012/download https://www.fda.gov/media/71012/download https://www.fda.gov/media/71012/download https://www.fda.gov/media/71012/download https://www.fda.gov/media/71012/download https://www.fda.gov/media/71012/download

APR Sept/Oct 2023

Table of Contents for the Digital Edition of APR Sept/Oct 2023