GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance

2017 ◽  
pp. 173-191
Author(s):  
Richard K. Burdick ◽  
David J. LeBlond ◽  
Lori B. Pfahler ◽  
Jorge Quiroz ◽  
Leslie Sidor ◽  
...  
Keyword(s):  
Continuous Process ◽  
Process Validation ◽  
Process Verification

scholarly journals Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification

Pharmaceutics ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 919
Author(s):  
Eun Ji Kim ◽  
Ji Hyeon Kim ◽  
Min-Soo Kim ◽  
Seong Hoon Jeong ◽  
Du Hyung Choi
Keyword(s):  
Pharmaceutical Industry ◽  
Product Quality ◽  
Real Time ◽  
Control Strategy ◽  
Process Analytical Technology ◽  
Drug Product ◽  
Continuous Process ◽  
Process Verification ◽  
Unit Operations ◽  
Analytical Technology

Various frameworks and methods, such as quality by design (QbD), real time release test (RTRT), and continuous process verification (CPV), have been introduced to improve drug product quality in the pharmaceutical industry. The methods recognize that an appropriate combination of process controls and predefined material attributes and intermediate quality attributes (IQAs) during processing may provide greater assurance of product quality than end-product testing. The efficient analysis method to monitor the relationship between process and quality should be used. Process analytical technology (PAT) was introduced to analyze IQAs during the process of establishing regulatory specifications and facilitating continuous manufacturing improvement. Although PAT was introduced in the pharmaceutical industry in the early 21st century, new PAT tools have been introduced during the last 20 years. In this review, we present the recent pharmaceutical PAT tools and their application in pharmaceutical unit operations. Based on unit operations, the significant IQAs monitored by PAT are presented to establish a control strategy for CPV and real time release testing (RTRT). In addition, the equipment type used in unit operation, PAT tools, multivariate statistical tools, and mathematical preprocessing are introduced, along with relevant literature. This review suggests that various PAT tools are rapidly advancing, and various IQAs are efficiently and precisely monitored in the pharmaceutical industry. Therefore, PAT could be a fundamental tool for the present QbD and CPV to improve drug product quality.

scholarly journals Recommended Best Practices for Lyophilization Validation 2021 Part II: Process Qualification and Continued Process Verification

2021 ◽  
Vol 22 (8) ◽  
Author(s):  
Feroz Jameel ◽  
Alina Alexeenko ◽  
Akhilesh Bhambhani ◽  
Gregory Sacha ◽  
Tong Zhu ◽  
...  
Keyword(s):  
Best Practices ◽  
Process Design ◽  
Control Charts ◽  
Batch Size ◽  
Drying Time ◽  
Process Validation ◽  
Process Verification ◽  
Process Qualification ◽  
The Impact ◽  
Validation Strategy

Abstract This work describes the lyophilization process validation and consists of two parts. Part one (Part I: Process Design and Modeling) focuses on the process design and is described in the previous paper, while the current paper is devoted to process qualification and continued process verification. The goal of the study is to show the cutting edge of lyophilization validation based on the integrated community-based opinion and the industrial perspective. This study presents best practices for batch size determination and includes the effect of batch size on drying time, process parameters selection strategies, and batch size overage to compensate for losses during production. It also includes sampling strategies to demonstrate batch uniformity as well as the use of statistical models to ensure adequate sampling. Based on the LyoHUB member organizations survey, the best practices in determining the number of PPQ runs are developed including the bracketing approach with minimum and maximum loads. Standard practice around CQA and CPP selection is outlined and shows the advantages of using control charts and run charts for process trending and quality control. The case studies demonstrating the validation strategy for monoclonal antibody and the impact of the loading process on the lyophilization cycle and product quality as well as the special case of lyophilization for dual-chamber cartridge system are chosen to illustrate the process validation. The standard practices in the validation of the lyophilization process, special lyophilization processes, and their impact on the validation strategy are discussed. Graphical Abstract

To Tell or Not to Tell, That Is the Question

2006 ◽  
Vol 11 (3) ◽  
pp. 236-243 ◽  
Author(s):  
Knut Dalen
Keyword(s):  
Gender Differences ◽  
Ethics Education ◽  
Ethical Dilemmas ◽  
Continuous Process ◽  
Telephone Counseling ◽  
Counseling Service ◽  
Telephone Service

Ethical dilemmas encountered by psychologists have previously been studied in surveys and as formal ethical complaints. No previous publications have been found in which data from an ethics counseling telephone service for psychologists has been analyzed. The present study examines ethical dilemmas, as presented by members of the Norwegian Psychological Association calling the Ethics Telephone Counseling Service (ETCS) from 2001 through 2003. Psychologists seek counseling for a range of ethical dilemmas. Ethical dilemmas concerning confidentiality are those most commonly presented. Dilemmas concerning integrity are also fairly common, whereas dilemmas concerning competence are rarely presented. The study shows virtually no difference in frequency and nature of consultation based on how long a psychologist has been licensed. This study also shows only minor gender differences in the use of the ETCS. Possible implications for ethics education as a continuous process are discussed.

EXPERIENCE OF CREATING AND IMPLEMENTING INFORMATION-MANAGING EDUCATIONAL ENVIRONMENT AT UNIVERSITY AND FEATURES OF ITS ADAPTATION AT LYCEUM

2019 ◽  
pp. 47-55 ◽  
Author(s):  
E. V. Shevchuk ◽  
A. V. Shpak
Keyword(s):  
Continuous Process ◽  
Educational Environment ◽  
Educational Process ◽  
Information Resources ◽  
Improve Quality ◽  
Educational Organizations ◽  
Educational Processes ◽  
Facilitating Conditions ◽  
Oriented Approach

The article describes experience of creating and implementing information-managing educational environment at university. The model of creating information-managing educational environment of university with elements of artificial intelligence and indicative management is described. This environment contributes to improve quality of training and management of educational processes and resources. The stages of creating and implementing information-managing educational environment are considered systemically, as continuous process focused on a consumer. The inhibitory and facilitating conditions for introduction of the model at university are described. To provide subject-oriented approach to the use of information resources of environment, recommended clusters of information subsystems for each category of users are described.Practically implemented scientific and methodological recommendations for subjects of educational process to overcome resistance to innovations introduced in educational organizations are proposed.Features of adaptation of the developed information-managing educational environment for schools are presented.

Vieillir, dit-elle: Nancy Huston's Feminist Trajectory and Writing Female Ageing

2018 ◽  
Vol 57 (3) ◽  
pp. 325-339
Author(s):  
Kate Averis
Keyword(s):  
Continuous Process ◽  
Later Life ◽  
Theoretical Framework ◽  
Feminist Studies ◽  
Process Of Change ◽  
Women’S Experiences ◽  
Existential Crisis ◽  
Women's Experiences ◽  
Gender And Age

This article examines Nancy Huston's writing of female ageing in light of her intellectual and personal trajectory as a feminist thinker. It identifies women's ageing as an integrative and ubiquitous phenomenon in Huston's œuvre, tracing the presence of this thematic and theoretical concern to her very first published works, and outlining its development until her most recent works, before examining a key instance of her fictional treatment of female ageing in Lignes de faille. Drawing on a literary, philosophical and sociological theoretical framework, it argues that Huston furthers feminist approaches to female senescence by inscribing women's experiences of later life not in terms of existential crisis but rather as part of the continuous process of change and transformation inherent to subjective development. The analysis aims to address pressing questions surrounding the intersections of gender and age that are at the forefront of Huston criticism and feminist studies.

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