PDA Journal of Pharmaceutical Science and Technology最新文献_第4页

Expanding the Use of Moist Heat for Terminal Sterilization. 扩大湿热技术在终端消毒中的应用。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-03-03 DOI: 10.5731/pdajpst.2023.012918

James Agalloco

引用次数: 0

PDA JPST's 2024 Outstanding Reviewers. PDA JPST的2024杰出评论家。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-03-03 DOI: 10.5731/pdajpst.2025.001225

引用次数: 0

Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry. 人工智能在持续过程验证中的应用建议。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-03-03 DOI: 10.5731/pdajpst.2024.012950

Mario Stassen, Catarina S Leitão, Toni Manzano, Francisco Valero, Benjamin Stevens, Matt Schmucki, David Hubmayr, Ferran Mirabent Rubinat, Sandrine Dessoy, Antonio Moreira

{"title":"Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry.","authors":"Mario Stassen, Catarina S Leitão, Toni Manzano, Francisco Valero, Benjamin Stevens, Matt Schmucki, David Hubmayr, Ferran Mirabent Rubinat, Sandrine Dessoy, Antonio Moreira","doi":"10.5731/pdajpst.2024.012950","DOIUrl":"10.5731/pdajpst.2024.012950","url":null,"abstract":"This review paper explores the transformative impact of Artificial Intelligence (AI) on Continued Process Verification (CPV) in the biopharmaceutical industry. Originating from the CPV of the Future project, the study investigates the challenges and opportunities associated with integrating AI into CPV, focusing on real-time data analysis and proactive process adjustments. The paper highlights the importance of aligning AI solutions with regulatory standards and offers a set of comprehensive recommendations to bridge the gap between AI's potential and its practical, compliant, and safe application in pharmaceutical manufacturing. Emphasizing transparency, interpretability, and risk management, the research contributes to establishing best practices for AI implementation, ensuring the highest quality pharmaceutical products while meeting regulatory expectations. The conclusions drawn provide valuable insights for navigating the evolving landscape of AI in pharmaceutical manufacturing. This paper serves as a guideline for implementing AI, Machine Learning and Deep Learning models to the pharma industry. Nevertheless, the specific algorithms used in the CPV of the Future are not relevant for our paper (Good Practices), since we have to generalize the process independent of the algorithm.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"68-87"},"PeriodicalIF":0.0,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142896704","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys. 理解在实验室之间执行可提取筛选研究的一致性：ELSIE实验室实践子团队行业调查的结果。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-03-03 DOI: 10.5731/pdajpst.2024.012964

Steven A Zdravkovic, Qiang Fu, Aaron Flick, Bhargava Jana, Elizabeth Looney, Samuel Kikandi, Tim Verdonck, Lee Nagao, Mary Kate Bielinski

{"title":"Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys.","authors":"Steven A Zdravkovic, Qiang Fu, Aaron Flick, Bhargava Jana, Elizabeth Looney, Samuel Kikandi, Tim Verdonck, Lee Nagao, Mary Kate Bielinski","doi":"10.5731/pdajpst.2024.012964","DOIUrl":"10.5731/pdajpst.2024.012964","url":null,"abstract":"Substances that can be extracted (extractables) from the components of a medical device or a pharmaceutical product's manufacturing, packaging, and/or delivery system(s) are characterized as part of an extractable screening study to ensure the safety of the associated therapy. While the requirements of such studies have been established on a strategic level, the tactical approaches for their execution are less controlled, and as such, have been established on a laboratory-by-laboratory basis. Based on anecdotal accounts, differences in these tactical variables have resulted in inconsistent data obtained between laboratories when all other factors are equal. To better understand this potential issue, the Lab Practices Working Group within the Extractable & Leachable Safety Information Exchange (ELSIE) has conducted two surveys of the practices used by several pharmaceutical sponsors and contract research organizations for their execution of extractable screening studies. The results obtained from these surveys uncovered a lack of alignment in some experimental variables for the execution of these studies including selection and use of surrogate standard(s), establishment of system suitability, qualification of screening methods, and use of uncertainty factors. Accordingly, it was concluded that the potential exists for at least some differences in the data obtained from extractable screening studies between laboratories due to the inconsistencies in their execution uncovered in these surveys.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 1","pages":"4-27"},"PeriodicalIF":0.0,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143542964","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT). 使用前/灭菌后完整性检测（PUPSIT）的风险评估和基于风险的方法综述。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-03-03 DOI: 10.5731/pdajpst.2024-003038.1

Kelly Waldron, Amanda McFarland, Hal Baseman, Maik Jornitz

{"title":"A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT).","authors":"Kelly Waldron, Amanda McFarland, Hal Baseman, Maik Jornitz","doi":"10.5731/pdajpst.2024-003038.1","DOIUrl":"10.5731/pdajpst.2024-003038.1","url":null,"abstract":"In January 2023, ICH Q9 was updated to include expanded guidance on risk-based decision-making, emphasizing its application in informing science-driven and strategic decisions. The revised guidance highlights that while quality risk management can aid decision-making, it does not eliminate the industry's obligation to comply with regulatory requirements. This article introduces a framework for evaluating the risks and benefits of pre-use/post-sterilization integrity testing (PUPSIT) using risk management principles. It provides a structured approach to assess the acceptability of alternative methods to the EU Annex 1 PUPSIT requirement, which acknowledges that PUPSIT may not always be feasible due to constraints such as the filtration of small solution volumes. In such cases, Annex 1 permits alternative approaches if a comprehensive risk assessment is conducted and effective controls are implemented to mitigate the risk of non-integral filtration systems. The proposed framework considers three critical domains-patient safety, process integrity, and regulatory compliance-to ensure decisions are well-informed and balanced. By applying this science- and risk-based approach, organizations can navigate PUPSIT requirements effectively, ensuring compliance while addressing operational limitations.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 1","pages":"88-97"},"PeriodicalIF":0.0,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143542960","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation. 通过非目标分析（NTA）处理医疗器械可提取物和可浸出物分析评价阈值（AET）与定量。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-03-03 DOI: 10.5731/pdajpst.2024.012945

Dennis Jenke, Piet Christiaens, Ted Heise

{"title":"Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation.","authors":"Dennis Jenke, Piet Christiaens, Ted Heise","doi":"10.5731/pdajpst.2024.012945","DOIUrl":"10.5731/pdajpst.2024.012945","url":null,"abstract":"Substances leached from a medical device during its clinical use are important due to the patient health-related effects they may have. Thus, medical devices are profiled for leachables (and/or extractables as probable leachables) by screening extracts or leachates of the medical device for released organic substances via a non-target analysis (NTA) employing chromatographic methods coupled with mass spectrometric detection. Chromatographic mass spectral response factors for extractables and leachables vary significantly from compound to compound, complicating the application of assessment strategies such as the analytical evaluation threshold (AET), which is the concentration threshold at or above which an extractable or leachable must be reported for quantitative toxicological risk assessment. The analytical uncertainty resulting from response variation can make interpretation of the AET difficult, potentially leading to both false positive and false negative outcomes. Furthermore, response factor variation complicates the estimation of leachables' and extractables' concentrations (quantification). This Correspondence discusses practices for the calculation and application of the AET and for performing quantification, including a discussion of accuracy versus protectiveness.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"98-113"},"PeriodicalIF":0.0,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142896699","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A Risk Assessment and Risk Based Approach Review of Pre-use/Post Sterilization Integrity Testing (PUPSIT). 消毒前/消毒后完整性检测（PUPSIT）的风险评估和基于风险的方法综述。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-02-10 DOI: 10.5731/pdajpst.2024.003038

Kelly Waldron, Amanda McFarland, Hal Baseman, Maik Jornitz

{"title":"A Risk Assessment and Risk Based Approach Review of Pre-use/Post Sterilization Integrity Testing (PUPSIT).","authors":"Kelly Waldron, Amanda McFarland, Hal Baseman, Maik Jornitz","doi":"10.5731/pdajpst.2024.003038","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.003038","url":null,"abstract":"In January 2023, ICHQ9 was updated to include expanded guidance on risk-based decision-making, emphasizing its application in informing science-driven and strategic decisions. The revised guidance highlights that while quality risk management can aid decision-making, it does not eliminate the industry's obligation to comply with regulatory requirements. This article introduces a framework for evaluating the risks and benefits of pre-use/post-sterilization integrity testing (PUPSIT) using risk management principles. It provides a structured approach to assess the acceptability of alternative methods to the EU Annex 1 PUPSIT requirement, which acknowledges that PUPSIT may not always be feasible due to constraints such as the filtration of small solution volumes. In such cases, Annex 1 permits alternative approaches if a comprehensive risk assessment is conducted and effective controls are implemented to mitigate the risk of non-integral filtration systems. The proposed framework considers three critical domainspatient safety, process integrity, and regulatory complianceto ensure decisions are well-informed and balanced. By applying this science- and risk-based approach, organizations can navigate PUPSIT requirements effectively, ensuring compliance while addressing operational limitations.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143391542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Case Study: Visual Inspection of Topical Ophthalmic Formulations Packaged in Opaque and Semi-Transparent Containers: Working towards alignment with USP<790> Visible Inspection of Injections. 案例研究：包装在不透明和半透明容器中的局部眼科配方的目视检查：努力与USP注射剂可见检查保持一致。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-02-10 DOI: 10.5731/pdajpst.2024.003017

Mary Lee Ciolkowski, Ann T Davis, Alexa Harding, Stacey M Platzer

{"title":"Case Study: Visual Inspection of Topical Ophthalmic Formulations Packaged in Opaque and Semi-Transparent Containers: Working towards alignment with USP<790> Visible Inspection of Injections.","authors":"Mary Lee Ciolkowski, Ann T Davis, Alexa Harding, Stacey M Platzer","doi":"10.5731/pdajpst.2024.003017","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.003017","url":null,"abstract":"Topical ophthalmic solutions, suspensions, and emulsions are typically packaged in opaque or semi-transparent plastic dropper bottles. This packaging provides resistance to breakage and controlled drop size needed in ophthalmic container systems. Recent changes to general chapter USP<771> Ophthalmic Products - Quality Tests have impacted the particulate and foreign matter testing requirements for ophthalmic products dosed via topical application. The USP<771> chapter instructs that topical products undergo visual inspection for particulate matter as described in general chapter USP<790> Visible Particulates in Injections Visual inspection for particulates in the filled unit is not feasible due to lack of package transparency and therefore alternative test strategies are needed to evaluate the acceptability of the batch. Aspects of this visual inspection approach include: a statistically based sampling plan for the batch, a destructive testing process and acceptance limits based on manufacturing process capability supported with benchmark testing of competitor products to confirm manufacturing performance. Overall, the visual inspection program should include: historical trending; process monitoring; and upstream lifecycle controls for facilities, raw materials, components, and product contact equipment to meet current regulatory expectations and good manufacturing practices.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143391546","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Meaningful & Measurable Risk Assessment Tools for Environmental Monitoring Site Selection Program. 环境监测选址方案中有意义和可测量的风险评估工具。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-12-26 DOI: 10.5731/pdajpst.2024.99908

Vanessa Vasadi Figueroa

{"title":"Meaningful & Measurable Risk Assessment Tools for Environmental Monitoring Site Selection Program.","authors":"Vanessa Vasadi Figueroa","doi":"10.5731/pdajpst.2024.99908","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.99908","url":null,"abstract":"The role of Environmental Monitoring has evolved alongside the manufacturing processes and filling technologies its aims to monitor, and so should the risk assessment tools we implement for establishing this important program. Sample site selection, appropriateness of sampling methods, sampling volumes and sampling frequencies are all important components of contamination control for a facility and must be evaluated as appropriate using a robust risk assessment. The types of environmental monitoring required for a robust program will vary based on the type of operation, frequency in which that operation is performed, and the level of risk associated to the process. Learn how to develop a meaningful risk assessment and include measurable risk rankings for 6 applicable categories in biopharmaceutical manufacturing. The process for scoring each of the 6 categories, systematic evaluation of contamination probability and example outcomes will be shared for theoretical EM sites mapped throughout an ISO 5 and 7 cleanroom area, thus ensuring adequate criteria and fair assessment are applied in each case. The methodology for this risk assessment tool will be demonstrated as suitable for environmental monitoring programs during initial site qualification, when evaluating EMPQ results, or when periodically updating the requirements for monitoring during routine operations.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"78 6","pages":"765-766"},"PeriodicalIF":0.0,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142895438","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Contamination Control Strategy (CCS), Check! Now What? Lifecycle Management of CCS. 污染控制策略（CCS），检查！现在怎么办呢?CCS的生命周期管理。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-12-26 DOI: 10.5731/pdajpst.2024.99901

Hilary Chan

引用次数: 0