The Experts below are selected from a list of 4416 Experts worldwide ranked by ideXlab platform
Human Services - One of the best experts on this subject based on the ideXlab platform.
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Guidance for Industry Process Validation : General Principles and Practices Guidance for Industry Process Validation : General Principles and Practices
Quality, 2011Co-Authors: Human ServicesAbstract:This guidance outlines the general principles and approaches that FDA considers appropriate elements of Process Validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs or drug substances), collectively referred to in this guidance as drugs or products. This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing Processes.
Lanju Zhang - One of the best experts on this subject based on the ideXlab platform.
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Process Design: Stage 1 of the FDA Process Validation Guidance
Statistical Applications for Chemistry Manufacturing and Controls (CMC) in the Pharmaceutical Industry, 2020Co-Authors: Richard K. Burdick, David J. Leblond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju ZhangAbstract:This is the first of three chapters that describe statistical approaches related to the three stages of Process Validation described in the FDA Process Validation Guidance for Industry (2011). The three stages are
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Process Qualification: Stage 2 of the FDA Process Validation Guidance
Statistical Applications for Chemistry Manufacturing and Controls (CMC) in the Pharmaceutical Industry, 2017Co-Authors: Richard K. Burdick, David J. Leblond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju ZhangAbstract: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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GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance
Statistical Applications for Chemistry Manufacturing and Controls (CMC) in the Pharmaceutical Industry, 2017Co-Authors: Richard K. Burdick, David J. Leblond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju ZhangAbstract:The FDA Process Validation Guidance (2011) advocates Continued Process verification Procedure Validation a life cycle approach to product manufacturing which ensures the Process can reliably and consistently produce quality product that meets the therapy’s desired efficacy and safety profile. This life cycle approach emphasizes collection and evaluation of appropriate data as evidence to demonstrate that the Process is in a controlled state to deliver quality product. It has three stages: Process design, Process qualification, and continued Process verification (CPV). In CPV stage, data are continuously collected and evaluated to verify the Process remains in the desired controlled state. This chapter discusses the key components of CPV and statistical tools that are useful for this purpose.
Igor Gorsky - One of the best experts on this subject based on the ideXlab platform.
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Process Validation Stage 3: Continued Process Verification
Principles of Parenteral Solution Validation, 2020Co-Authors: Igor GorskyAbstract:Abstract This chapter will discuss Stage 3 of Process Validation Program—Continued Process Verification (CPV). First of all, it is important to understand regulation requirements that are behind the concept of continued verification of Critical Process Parameters and Critical Quality Attributes (CQA). Before we start this discussion, one should distinguish between “continued” and “continuous” designation in the definition of this stage of Process Validation.
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Process Validation Stage 1: Parenteral Process Design
Principles of Parenteral Solution Validation, 2020Co-Authors: Igor GorskyAbstract:Abstract This chapter discusses Stage 1 of Process Validation which outlines steps to be taken to perform a Design of the Pharmaceutical Process. This is the most important stage of Process Validation continuum where Product Critical Quality Attributes (CQAs) are documented in Quality Target Therapeutic Profile (QTTP). In addition, Materials Attributes (MAs), Critical Process Parameters, and Process Control Strategy are determined using Risk Management tools.
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Use of Statistics in Process Validation
Principles of Parenteral Solution Validation, 2020Co-Authors: Igor GorskyAbstract:Abstract The chapter describes the use of statistics in Process Validation life cycle. Case studies and examples as well as use of statistical methods in designing the Process, in Process performance qualification and during continued Process verification are shown.
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Process Validation Stage 2: Parenteral Process Performance Qualification
Principles of Parenteral Solution Validation, 2020Co-Authors: Harold S. Baseman, Igor GorskyAbstract:Abstract The chapter describes Stage 2 of Process Validation–Process performance qualification (PPQ). When design of the Process is finalized, it is a time for commercialization of the Process. General principles of the PPQ are discussed as they applied for aseptic Processing.
Richard K. Burdick - One of the best experts on this subject based on the ideXlab platform.
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Process Design: Stage 1 of the FDA Process Validation Guidance
Statistical Applications for Chemistry Manufacturing and Controls (CMC) in the Pharmaceutical Industry, 2020Co-Authors: Richard K. Burdick, David J. Leblond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju ZhangAbstract:This is the first of three chapters that describe statistical approaches related to the three stages of Process Validation described in the FDA Process Validation Guidance for Industry (2011). The three stages are
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Process Qualification: Stage 2 of the FDA Process Validation Guidance
Statistical Applications for Chemistry Manufacturing and Controls (CMC) in the Pharmaceutical Industry, 2017Co-Authors: Richard K. Burdick, David J. Leblond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju ZhangAbstract: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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GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance
Statistical Applications for Chemistry Manufacturing and Controls (CMC) in the Pharmaceutical Industry, 2017Co-Authors: Richard K. Burdick, David J. Leblond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju ZhangAbstract:The FDA Process Validation Guidance (2011) advocates Continued Process verification Procedure Validation a life cycle approach to product manufacturing which ensures the Process can reliably and consistently produce quality product that meets the therapy’s desired efficacy and safety profile. This life cycle approach emphasizes collection and evaluation of appropriate data as evidence to demonstrate that the Process is in a controlled state to deliver quality product. It has three stages: Process design, Process qualification, and continued Process verification (CPV). In CPV stage, data are continuously collected and evaluated to verify the Process remains in the desired controlled state. This chapter discusses the key components of CPV and statistical tools that are useful for this purpose.
Leslie Sidor - One of the best experts on this subject based on the ideXlab platform.
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Using risk analysis in Process Validation
Biopharm International, 2020Co-Authors: Leslie Sidor, Paul LewusAbstract:Process Validation is used to confirm that the resulting product from a specified Process consistently conforms to product requirements. A risk-based approach to Process Validation provides a rational framework for developing an appropriate scope for Validation activities, focusing on Processes that have the greatest potential risk to product quality. This article presents a case study in which a risk-based approach was used to evaluate a typical mammalian cell culture and purification Process. This risk assessment used a Failure Modes and Effects Analysis (FMEA) to evaluate the impact of potential failures and the likelihood of their occurrence for each unit operation. Unit operations included in the Process Validation required a risk priority number greater than or equal to a specified threshold value. Unit operations that fell below the threshold were evaluated for secondary criteria such as regulatory expectations or historical commitments. The risk assessment covered the entire Process and a portion of the assessment is reviewed here.
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Process Design: Stage 1 of the FDA Process Validation Guidance
Statistical Applications for Chemistry Manufacturing and Controls (CMC) in the Pharmaceutical Industry, 2020Co-Authors: Richard K. Burdick, David J. Leblond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju ZhangAbstract:This is the first of three chapters that describe statistical approaches related to the three stages of Process Validation described in the FDA Process Validation Guidance for Industry (2011). The three stages are
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Process Qualification: Stage 2 of the FDA Process Validation Guidance
Statistical Applications for Chemistry Manufacturing and Controls (CMC) in the Pharmaceutical Industry, 2017Co-Authors: Richard K. Burdick, David J. Leblond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju ZhangAbstract: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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GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance
Statistical Applications for Chemistry Manufacturing and Controls (CMC) in the Pharmaceutical Industry, 2017Co-Authors: Richard K. Burdick, David J. Leblond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju ZhangAbstract:The FDA Process Validation Guidance (2011) advocates Continued Process verification Procedure Validation a life cycle approach to product manufacturing which ensures the Process can reliably and consistently produce quality product that meets the therapy’s desired efficacy and safety profile. This life cycle approach emphasizes collection and evaluation of appropriate data as evidence to demonstrate that the Process is in a controlled state to deliver quality product. It has three stages: Process design, Process qualification, and continued Process verification (CPV). In CPV stage, data are continuously collected and evaluated to verify the Process remains in the desired controlled state. This chapter discusses the key components of CPV and statistical tools that are useful for this purpose.