PDA Journal of Pharmaceutical Science and Technology最新文献_第3页

Practical application of setting up an annual Contamination Control Strategy (CCS) assessment. 建立年度污染控制策略（CCS）评估的实际应用。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-03-25 DOI: 10.5731/pdajpst.2024-003018

R van der Galiën, A L Langen, L J M Jacobs, P Sawant Raschdorf, A Xing, M C van Amsterdam

{"title":"Practical application of setting up an annual Contamination Control Strategy (CCS) assessment.","authors":"R van der Galiën, A L Langen, L J M Jacobs, P Sawant Raschdorf, A Xing, M C van Amsterdam","doi":"10.5731/pdajpst.2024-003018","DOIUrl":"https://doi.org/10.5731/pdajpst.2024-003018","url":null,"abstract":"A Contamination Control Strategy (CCS) is a strategy that focuses on how to prevent contaminations with microorganisms, particles and pyrogens and manages risks to medicinal product quality and patient safety within a GMP facility. A CCS should reflect on all proactive and retrospective data within a sterile and/or aseptic and/or non-sterile manufacturing environment, to identify all sources of contamination and associated hazards and/or control measures. It should outline associated Quality Risk Assessments (QRAs), Critical Control Points (CCPs) and suggest necessary control measures. An effective way to perform QRA for CCS is adopting the Hazard Analysis Critical Control Point (HACCP) methodology, a proactive risk assessment tool. This tool can be ideally used to monitor all CCPs associated with various sources of contamination.To keep the CCS effective, it is highly recommended to have the CCS reviewed by a multidisciplinary team and updated periodically, and to re-review it as necessary in the event particular issues arise. An annual review of the CCS effectiveness can be performed by constructing an assessment tool in the form of a report. The report provides an overview of all proactive and retrospective Quality Management System (QMS) related data that may have an impact on the CCS. This report then acts as a tool to drive continual improvement of the manufacturing and control methods, as required per EudraLex Volume 4 GMP guidelines Annex 1. This article describes a practical application of setting up an annual CCS assessment within a pharmaceutical manufacturing company to keep the CCS effective. This assessment will facilitate the process of reviewing the effectiveness of all control measures over time and facilitates escalation of issues that are not under control.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143710837","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

Definition of Particle Visibility Threshold in Parenteral Drug Products-Towards Standardization of Visual Inspection Operator Qualification. 肠外药品颗粒可见性阈值的定义——面向视觉检验操作人员资格的标准化。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-03-03 DOI: 10.5731/pdajpst.2024.012994

Filip M Fedorowicz, Andreas Zerr, Roman Mathaes, Matthias Eisele, Swen Maas, Atanas Koulov

{"title":"Definition of Particle Visibility Threshold in Parenteral Drug Products-Towards Standardization of Visual Inspection Operator Qualification.","authors":"Filip M Fedorowicz, Andreas Zerr, Roman Mathaes, Matthias Eisele, Swen Maas, Atanas Koulov","doi":"10.5731/pdajpst.2024.012994","DOIUrl":"10.5731/pdajpst.2024.012994","url":null,"abstract":"The detectability size threshold of visible particles (\"visibility\" size) in the context of visual inspection of parenteral drug products has been an elusive target for several decades. The current common sense, also reflected in official guidelines, dictates that particles of different shapes and morphologies have different \"visibility\" size thresholds, which can range between hundreds and thousands of micrometers. This study demonstrates experimentally for the first time that it is possible to define a single, shape- and morphology-independent detectability size threshold, identical across particles of various types, provided that observation conditions and product attributes are kept constant. We propose that, based on the physiology of human visual perception instead of single-dimension measures of particle size (e.g., diameter or length), such a single size-threshold requires the use of area-based size parameters (such as \"equivalent circular diameter\", or ECD. The experimental results reported here clearly demonstrate that the \"visibility\" thresholds for particles of various morphologies converge on a single ECD value. In addition, the data reported here show that product attributes, such as container configuration, fill volume, etc. influence the threshold of visibility. Collectively, the findings reported in this paper provide substantial evidence and scientific rationale, as well as unanticipated prospects for standardization of visual inspection qualification practices, ultimately leading to improvement of pharmaceutical product quality.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"28-58"},"PeriodicalIF":0.0,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142896701","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

2025 January/February Editorial. 2025年1 / 2月社论。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-03-03 DOI: 10.5731/pdajpst.2025.001941

Ghada Haddad

引用次数: 0

Visual Inspection of Topical Ophthalmic Formulations Packaged in Opaque and Semi-Transparent Containers: Working Towards Alignment with USP<790> Visible Particulates in Injections. 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：努力与注射剂中的USP可见颗粒对齐。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-03-03 DOI: 10.5731/pdajpst.2024-003017.1

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

{"title":"Visual Inspection of Topical Ophthalmic Formulations Packaged in Opaque and Semi-Transparent Containers: Working Towards Alignment with USP<790> Visible Particulates in Injections.","authors":"Mary Lee Ciolkowski, Ann T Davis, Alexa Harding, Stacey M Platzer","doi":"10.5731/pdajpst.2024-003017.1","DOIUrl":"10.5731/pdajpst.2024-003017.1","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 the controlled drop size needed in ophthalmic container systems. Recent changes to 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 USP <790> Visible Particulates in Injections Visual inspection for particulates in the filled unit is not feasible due to the 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 life cycle 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":"79 1","pages":"59-67"},"PeriodicalIF":0.0,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143542982","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

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