Abstract
In Chap. 3, the first stage of the FDA’s 2011 process validation guidance was described demonstrating various options to drive process understanding using experimental design . The resulting process design experiments yield information that can be used to define future operating ranges for the new process. The second stage of process validation is process qualification.
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References
ASTM E2475 (2010) Standard guide for process understanding related to pharmaceutical manufacture and control. ASTM International, West Conshohocken
Breen C, Somayajula D A, Altekar M, Patel P, Lewis R (2016) Determining the number of process performance qualification batches using statistical tools—supplement to prior discussion paper
Bryder M, Etling H, Flemming J, Hu Y, Levy P (2012, updated 2014) Topic 1—stage 2 process validation: determining and justifying the number of process performance qualification batches (Version 2). ISPE discussion paper. (www.ispe.org/discussion-papers/stage-2-process-validation.pdf)
Chao S-B (2005) Risk-based approach for biological process validation: Integrating process validation with product development. J Validation Technol 12(1):54–68
Doymaz F, Ye F, Burdick R (2015) Product homogeneity assessment during validation of biopharmaceutical drug product manufacturing processes. In: Jameel F, Hershenson S, MA K, Martin-Moe S (eds) Appears in quality by design for biopharmaceutical drug product development. Springer Science & Business Media, LLC, New York, pp 649–659
European Medicines Agency (EMA) (2014) Guideline on process validation for finished products—information and data to be provided in regulatory submissions
International Conference on Harmonization (2000) Q7 good manufacturing practice guide for active pharmaceutical ingredients
International Conference on Harmonization (2005) Q9 quality risk management
Levy P (2012) Determining and justifying the number of process validation batches: making initial batch release decisions. ISPE: Lessons from 483s Process Validation Track
O’Donnell K, Greene A (2006a) A risk management solution designed to facilitate risk-based qualification, validation, and change control activities within GMP and pharmaceutical regulatory compliance environments in the EU: part I fundamental principles, design criteria, outline of process. J GXP Compliance 10(4):12–25
O’Donnell K, Greene A (2006b) A risk management solution designed to facilitate risk-based qualification, validation, and change control activities within GMP and pharmaceutical regulatory compliance environments in the EU: part II tool scope, structure, limitations, principle findings, and novel elements. J GXP Compliance 10(4):26–35
Parenteral Drug Association (PDA) (1998) Technical Report No. 29: Points to consider for cleaning validation
Sidor L (2013) PPQ lot tool: determining the number of lots in PPQ. Validation Information Group, PDA Annual Meeting (April)
Sidor L (2014) How many batches for PPQ? AAPS National Biotechnology Conference Short Course (May)
Sidor L, Lewus P (2007) Validation and compliance: using risk analysis in process validation. BioPharm Int 20(2). http://www.biopharminternational.com/validation-compliance-using-risk-analysis-process-validation?id=&sk=&date=&%0A%09%09%09&pageID=2
Strickland H, Altan S (2016) Process validation in the twenty-first century. In: Zhang L (ed) Chapter 19 of nonclinical statistics for pharmaceutical and biotechnology industries. Springer, Heidelberg, pp 501–531
Yang H (2013) How many batches are needed for process validation under the new FDA guidance? PDA J Pharm Sci Technol 67:53–62
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Burdick, R.K. et al. (2017). Process Qualification: Stage 2 of the FDA Process Validation Guidance. In: Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry. Statistics for Biology and Health. Springer, Cham. https://doi.org/10.1007/978-3-319-50186-4_4
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DOI: https://doi.org/10.1007/978-3-319-50186-4_4
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