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A Risk Assessment and Risk Based Approach Review of Pre-use/Post Sterilization Integrity Testing (PUPSIT).
Q3 Medicine Pub Date : 2025-02-10 DOI: 10.5731/pdajpst.2024.003038
Kelly Waldron, Amanda McFarland, Hal Baseman, Maik Jornitz

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.

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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.
Q3 Medicine Pub Date : 2025-02-10 DOI: 10.5731/pdajpst.2024.003017
Mary Lee Ciolkowski, Ann T Davis, Alexa Harding, Stacey M Platzer

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.

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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。
Q3 Medicine Pub Date : 2024-12-27 DOI: 10.5731/pdajpst.2024.012994
Filip Fedorowicz, Andreas Zerr, Roman Mathaes, Matthias Eisele, Swen Maas, Atanas Koulov

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, that 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 improving pharmaceutical product quality.

几十年来,在肠外药品目视检查的背景下,可见颗粒的可检测大小阈值(″可见度″大小)一直是一个难以捉摸的目标。目前的常识也反映在官方的指导方针中,即不同形状和形态的粒子具有不同的″可见性″尺寸阈值,其范围可以在数百到数千微米之间。本研究首次通过实验证明,在观察条件和产品属性保持不变的情况下,有可能定义一个单一的、与形状和形态无关的可检测性尺寸阈值,该阈值在不同类型的颗粒之间相同。我们建议,基于人类视觉感知的生理学,而不是单一维度的粒度测量(如直径或长度),这种单一的尺寸阈值需要使用基于区域的尺寸参数(如″等效圆直径″,或ECD)。本文报道的实验结果清楚地表明,不同形态颗粒的″可见性″阈值收敛于单个ECD值。此外,这里报告的数据表明,产品属性,如容器配置,填充量等影响可见性阈值。总的来说,本文报告的研究结果为目视检验合格实践的标准化提供了充分的证据和科学依据,以及意想不到的前景,最终导致药品质量的提高。
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引用次数: 0
Recommendations for Artificial Intelligence Application in Continued Process Verification. 人工智能在持续过程验证中的应用建议。
Q3 Medicine Pub Date : 2024-12-27 DOI: 10.5731/pdajpst.2024.012950
Mario Stassen, Catarina S Leitao, Toni Manzano, Francisco Valero, Benjamin Stevens, Matt Schmucki, David Hubmayr, Ferran Mirabent Rubinat, Sandrine Dessoy, Antonio R Moreira

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.

本文探讨了人工智能(AI)对生物制药行业持续过程验证(CPV)的变革性影响。该研究源于未来CPV项目,研究了将人工智能融入CPV的挑战和机遇,重点关注实时数据分析和主动流程调整。该文件强调了使人工智能解决方案与监管标准保持一致的重要性,并提供了一套全面的建议,以弥合人工智能的潜力与其在制药制造中的实际、合规和安全应用之间的差距。该研究强调透明度、可解释性和风险管理,有助于建立人工智能实施的最佳实践,确保最高质量的药品,同时满足监管期望。得出的结论为引导制药行业人工智能的发展前景提供了有价值的见解。
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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。
Q3 Medicine Pub Date : 2024-12-27 DOI: 10.5731/pdajpst.2024.012945
Dennis Jenke, Piet Christiaens, Ted Heise

Leachables 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 non-targeted 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 best practice recommendations for the calculation and application of the AET and for performing quantification, including a discussion of accuracy versus protectiveness.

在临床使用期间从医疗设备中浸出的可浸物很重要,因为它们可能对患者健康产生影响。因此,通过采用色谱方法与质谱检测相结合的非靶向分析(NTA)筛选医疗器械的提取物或浸出液以检测释放的有机物质,从而对医疗器械进行可浸出物(和/或可提取物作为可能的可浸出物)的分析。可萃取物和可浸出物的色谱质谱响应因子因化合物而异,使评估策略的应用复杂化,例如分析评估阈值(AET),这是可萃取物或可浸物必须报告定量毒理学风险评估的浓度阈值。由反应变化引起的分析不确定性可能使AET的解释变得困难,可能导致假阳性和假阴性结果。此外,响应因子的变化使可浸出物和可萃取物浓度的估计(定量)复杂化。本通信讨论了AET的计算和应用以及执行量化的最佳实践建议,包括准确性与保护性的讨论。
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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。
Q3 Medicine Pub Date : 2024-12-26 DOI: 10.5731/pdajpst.2024.99908
Vanessa Vasadi Figueroa

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.

环境监测的作用随着其监测目标的制造过程和灌装技术的发展而发展,我们为建立这一重要项目而实施的风险评估工具也应如此。采样地点的选择、采样方法的适当性、采样量和采样频率都是设施污染控制的重要组成部分,必须酌情使用可靠的风险评估进行评估。一个健全的程序所需的环境监测类型将根据操作的类型、执行操作的频率以及与该过程相关的风险等级而有所不同。学习如何开发一个有意义的风险评估,并包括可衡量的风险排名在生物制药生产的6个适用类别。对6个类别中的每一个进行评分的过程、污染概率的系统评估和示例结果将在整个ISO 5和7级洁净室区域的理论EM站点中共享,从而确保在每种情况下应用充分的标准和公平的评估。此风险评估工具的方法将被证明适用于环境监测项目的初始场地鉴定,评估EMPQ结果,或在日常操作中定期更新监测要求。
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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。
Q3 Medicine Pub Date : 2024-12-26 DOI: 10.5731/pdajpst.2024.99901
Hilary Chan

Establishing a Contamination Control Strategy (CCS) is a requirement per EU Annex 1 (Aug 2022).  Once a CCS is established, the challenge becomes; "how do I ensure appropriate lifecycle management and effectiveness monitoring for my CCS?"  According to Annex 1, "The CCS should be actively reviewed and, where appropriate, updated and should drive continual improvement of the manufacturing and control methods. Its effectiveness should form part of the periodic management review."  This presentation will provide examples of how a pharma company is integrating CCS review into existing quality management system processes to ensure CCS remains updated and accurate.  Additionally, the use of tools to automate and digitize monitoring of the effectiveness of CCS will be presented.

建立污染控制策略(CCS)是欧盟附件1(2022年8月)的要求。一旦建立了CCS,挑战就变成了;“如何确保对CCS进行适当的生命周期管理和有效性监控?”根据附件1,“CCS应积极审查,并在适当的情况下进行更新,并应推动生产和控制方法的持续改进。”其有效性应成为定期管理审查的一部分。”本报告将举例说明制药公司如何将CCS审查整合到现有的质量管理体系流程中,以确保CCS保持更新和准确。此外,还将介绍使用工具对CCS的有效性进行自动化和数字化监测。
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引用次数: 0
Happy Holidays! 节日快乐!
Q3 Medicine Pub Date : 2024-12-26 DOI: 10.5731/pdajpst.2024.001846
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引用次数: 0
Replacing Traditional Aseptic Process Simulations with Qualification of Cell and Gene Therapy (CGT) Supernatant. 用细胞和基因治疗(CGT)上清鉴定取代传统无菌过程模拟。
Q3 Medicine Pub Date : 2024-12-26 DOI: 10.5731/pdajpst.2024.99910
Bernardo Perez, Johanna O'Bannon

Aseptic process simulations (APS) are traditionally performed using Tryptic Soy Broth (TSB) as a surrogate for finished product to qualify aseptic manufacturing operations. In this study, the supernatant from cell processing media was examined for bacterial and fungal growth viability to determine equivalency with TSB. With the use of cell processing media in Cell and Gene Therapy (CGT) manufacturing, can qualifying the supernatant collected from the process eliminate the need for an APS run?Supernatant was collected from cell processing media and incubated at same incubations conditions required for the APS post sterility check (Test A - 7d 20-25°C/7d 30-35°C) and at use conditions (Test B - 14 d at 35°C/5%CO/5%O2). Post incubation, growth promotion testing was performed using ATCC cultures (Ab+, Bs+, Ca+, Ec+, Sa+, Pa+ and Se+), which resulted in growth for Tests A-B and the positive inoculum control. Results concluded that the cell processing supernatant examined was equivalent to TSB, thereby implying that each cell therapy manufacturing run is aseptically self-validating. As more practical approaches emerge for APS qualifications in CGT manufacturing, this data can be used to implement alternate options to qualify a CGT manufacturing process and help establish guidelines for future cell therapy APS qualifications.

无菌过程模拟(APS)传统上使用胰蛋白酶豆汤(TSB)作为成品的替代品来验证无菌生产操作。在本研究中,对细胞处理培养基的上清液进行细菌和真菌生长活力检测,以确定与TSB的等效性。在细胞和基因治疗(CGT)生产中使用细胞处理介质,是否可以对从工艺中收集的上清进行鉴定,从而消除APS运行的需要?从细胞处理培养基中收集上清,在APS无菌后检查所需的相同孵育条件下(测试A - 7d 20-25°C/7d 30-35°C)和使用条件下(测试B - 14 d, 35°C/5%CO/5%O2)孵育。孵育后,使用ATCC培养物(Ab+、Bs+、Ca+、Ec+、Sa+、Pa+和Se+)进行生长促进试验,试验A-B和阳性接种对照均有生长。结果表明,细胞处理上清检测相当于TSB,从而意味着每个细胞治疗制造运行无菌自我验证。随着CGT制造中APS资格认证的更实用方法的出现,这些数据可用于实施CGT制造工艺资格认证的替代方案,并有助于建立未来细胞治疗APS资格认证的指导方针。
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引用次数: 0
Case Studies on Changes and Proposed Process Development Approaches Reflecting Applicability of PDA Technical Report No. 89: Strategies for Vaccine Development and Lifecycle Management. 关于变化和拟议工艺开发方法的案例研究,反映了 PDA 第 89 号技术报告《疫苗开发和生命周期管理战略》的适用性。
Q3 Medicine Pub Date : 2024-12-26 DOI: 10.5731/pdajpst.2024.012976
Cristiana Campa, Didier ClÉnet, Jane Halpern, Lyne Le Palaire, Mahesh Krishnan, Mic McGoldrick, Mihai Bilanin, Priyabrata Pattnaik, Richard Pelt, Sabrina Restrepo

Vaccines are complex and a very diverse group of products with relatively long product life cycles. The manufacturing programs for these vaccines need to be continually updated to comply with evolving regulatory expectations. Members of the Parenteral Drug Association (PDA) Vaccines Interest Group (VIG) authored and published PDA Technical Report No. 89: Strategies for Vaccine Development and Lifecycle Management (TR 89), which seeks to provide context to vaccine developers and manufacturers regarding key aspects of new or legacy vaccines such as control strategy from process development to vaccine life cycle management, comparability and life cycle management including technical, validation, quality, and regulatory perspectives. To further explain and illustrate the concepts and topics discussed, seven relevant situations were selected as either case studies associated with changes implemented or proposed process development strategies, which are discussed in this article. The situations described are: working cell bank, modification or update of externally supplied product contact components for vaccine manufacturing, raw material change, new product at an existing site, vaccine development acceleration by leveraging existing platforms, selection and implementation of potency method, and modeling for stability forecast prediction. For each situation, the applicable key concepts from TR 89 are discussed as follows: Control Strategy, Prior Knowledge, Relying on Pharmaceutical Quality System (PQS), Classification of Parameters, Validation Approach, Use of a Risk-Based Approach, Comparability, Use of ICH Q12, and Additional Regulatory Considerations.

疫苗是一类非常复杂和多样化的产品,产品生命周期相对较长。这些疫苗的生产计划需要不断更新,以符合不断变化的监管要求。肠外用药协会 (PDA) 疫苗兴趣小组 (VIG) 的成员撰写并出版了 PDA 第 89 号技术报告《疫苗开发和生命周期管理策略》(TR 89),该报告旨在为疫苗开发商和制造商提供有关新疫苗或传统疫苗关键方面的背景知识,例如从工艺开发到疫苗生命周期管理的控制策略、可比性和生命周期管理,包括技术、验证、质量和监管角度。为了进一步解释和说明所讨论的概念和主题,本文选取了七个相关情况作为案例研究,这些情况与已实施或拟议中的工艺开发战略变化有关。所描述的情况包括:工作细胞库、修改或更新用于疫苗生产的外部供应产品接触元件、原材料变更、在现有生产基地生产新产品、利用现有平台加速疫苗开发、选择和实施效价方法以及为稳定性预测建模。针对每种情况,将讨论 TR#89 中适用的关键概念如下:控制策略、先验知识、依赖 PQS、参数分类、验证方法、使用基于风险的方法、可比性、使用 ICHQ12 和其他监管考虑因素。
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引用次数: 0
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PDA Journal of Pharmaceutical Science and Technology
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