PDA Journal of Pharmaceutical Science and Technology最新文献

Quality Culture Revisited: Human Behavior as the Missing Link in Pharmaceutical Quality Management Systems. 质量文化重访：作为药品质量管理体系缺失环节的人的行为。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-10-11 DOI: 10.5731/pdajpst.2026-000018.1

George Hove

{"title":"Quality Culture Revisited: Human Behavior as the Missing Link in Pharmaceutical Quality Management Systems.","authors":"George Hove","doi":"10.5731/pdajpst.2026-000018.1","DOIUrl":"https://doi.org/10.5731/pdajpst.2026-000018.1","url":null,"abstract":"Pharmaceutical Quality Systems (PQS) based on ICH Q10 provide a formal framework for quality management, yet persistent quality failures, data integrity concerns, and regulatory observations indicate that structural compliance alone does not ensure effective performance. This narrative synthesis examines how human behavior contributes to PQS effectiveness and proposes that quality culture can be understood as the behavioral infrastructure through which PQS is enacted in practice.Through safety science, decision theory, organizational culture research, and published FDA Quality Management Maturity (QMM) materials, this paper explores how cognitive bias, normalization of deviance, psychological safety, and leadership signals influence core PQS elements, including process monitoring, deviation and CAPA management, change control, and management review. The synthesis proposes that differences in behavioral maturity may help explain why sites with comparable structural systems achieve different outcomes, while recognizing that this relationship is shaped by context, workload, incentives, and governance.A people‑systems model is introduced to describe how culture, behavior, and PQS structure interact to support sustained control and learning. The paper outlines practical implications for organizations seeking to strengthen behavioral indicators of PQS performance and suggests potential enhancements to regulatory inspection approaches, in which regulators interpret adaptive capacity and behavioral maturity primarily through objective evidence (for example, investigation depth, management review outputs, and CAPA effectiveness) alongside existing structural checks.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149170299","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 Discussion of Relevant and Meaningful Extraction Solvents for Extractables Testing of Implanted Medical Devices. 植入式医疗器械可提取物检测中相关且有意义的提取溶剂的讨论。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-10-09 DOI: 10.5731/pdajpst.2025-000056.1

Dennis Jenke

{"title":"A Discussion of Relevant and Meaningful Extraction Solvents for Extractables Testing of Implanted Medical Devices.","authors":"Dennis Jenke","doi":"10.5731/pdajpst.2025-000056.1","DOIUrl":"10.5731/pdajpst.2025-000056.1","url":null,"abstract":"During their clinical use, medical devices contact, directly or indirectly, tissue of the person (patient) whose medical condition is being treated or monitored by the device. During contact, substances present in or on the medical device can be leached from the device. Medical devices are chemically characterized to establish the patient's actual exposure to leachables. Establishing actual leachables from implanted methodical devices is problematic as so doing would require sampling of the in vivo environment in which the device is implanted. Thus, leachables from implanted medical devices are estimated by performing extraction studies. Often, such extraction studies use extraction solvents of multiple polarities to establish the device's total extractables profile (all possible extractables at their highest possible levels). As the potential range of extractables' polarities is large, using a small number of extraction solvents with widely different polarities can produce polarity gaps in which an extractable is either not revealed by the selected extraction solvents (an omission gap) or is underestimated in the extraction solvents (a magnitude gap). In either circumstance, the patient's exposure to extractables (as potential leachables) is underestimated. Furthermore, extraction studies that use extraction solvents with polarities outside of the polarity range of in vivo environments are inefficient, as they reveal extractables that cannot possibly be leachables at levels that cannot possibly be achieved during clinical use. After discussing these challenges from a thermodynamic and conceptual perspective, this author proposes that extraction studies for implanted medical devices use extraction solvents whose polarities bracket the polarity of the implanted in vivo environment and that a non-polar solvent never be used for bracketing purposes. To accomplish bracketing, this author introduces the polarity range termed \"seminonpolar\", establishes the polarity of in vivo environments, and specifies polarity brackets.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"638-654"},"PeriodicalIF":0.0,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145596853","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

Cancer Disparities and Research. 癌症差异和研究。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-10-09 DOI: 10.5731/pdajpst.2026.02615

引用次数: 0

Variability Assessment Methods for Lyophilized Drug Product, A Case Study. 冻干药品可变性评估方法的案例研究。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-10-09 DOI: 10.5731/pdajpst.2025-000046.1

Ajay Babu Pazhayattil, Marzena Ingram, Prasanna Sagar, Kishorkumar Kotini, Abhijit Bodhe, Mallinath Harwalkar, Satish Joshi, Subrata Chakraborty, Rajesh Sreedharan Nair, Ahmed Shaaban Elsaid

{"title":"Variability Assessment Methods for Lyophilized Drug Product, A Case Study.","authors":"Ajay Babu Pazhayattil, Marzena Ingram, Prasanna Sagar, Kishorkumar Kotini, Abhijit Bodhe, Mallinath Harwalkar, Satish Joshi, Subrata Chakraborty, Rajesh Sreedharan Nair, Ahmed Shaaban Elsaid","doi":"10.5731/pdajpst.2025-000046.1","DOIUrl":"10.5731/pdajpst.2025-000046.1","url":null,"abstract":"Lyophilization is a critical process, removing water and/or solvent through sublimation to ensure the stability and longevity of injectable drug products. The complexity of the lyophilization process, which involves multiple stages such as freezing, primary drying, and secondary drying, necessitates a robust approach to ensure product quality and consistency. Along with applying Quality by Design (QbD) principles in lyo process development, robust statistical and risk-based methodologies are essential for assessing process variability. This paper presents a risk-based and statistically sound sampling methodology for assessing variability in lyophilized drug products during Continued Process Verification (Stage 3a) of Process Validation. Sampling plans are strategically designed, ensuring representative data collection from lyophilizer shelves. By integrating variance analysis, capability indices, and probability, the methodology provides a comprehensive understanding of both intra-batch and inter-batch variability. The assessment enables estimation of future batch performance concerning critical quality attributes, including water content, assay, pH, and impurities. Identifying and controlling both intra-batch (within-shelf and between-shelf) and inter-batch variability ensures robustness. The study highlights the importance of statistically rigorous sampling plans, justification of the plans, and data analysis to ensure process control. A case study is presented, which demonstrates the application of the approach in a lyophilization process. The methodology supports regulatory compliance and enhances process understanding, enabling tighter process control and continuous improvement. The risk-based Stage 3a framework provides a structured method for post-commercialization variability assessment, bridging process design and continued verification.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"598-618"},"PeriodicalIF":0.0,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145596956","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

Non-Sterile Drug Products-Microbiologically Related Recalls and Compliance Issues. 非无菌药品。微生物相关召回和合规问题。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-10-09 DOI: 10.5731/pdajpst.2025-000058.1

Edward C Tidswell

{"title":"Non-Sterile Drug Products-Microbiologically Related Recalls and Compliance Issues.","authors":"Edward C Tidswell","doi":"10.5731/pdajpst.2025-000058.1","DOIUrl":"10.5731/pdajpst.2025-000058.1","url":null,"abstract":"Non-sterile drug products represent approximately 30% of annual drug sales. Non-sterile drug products offer therapeutic advantages, manufacturing costs that permit wide patient access, and versatility of dosage form and routes of administration, which facilitate patient compliance. These advantages have resulted in an increase in the number and nature of non-sterile finished dosage forms. Regulations and standards require the provision of non-sterile drugs to controlled levels of bioburden, the absence of specified microorganisms, and the absence of objectionable microorganisms. Thoroughly understanding the microbiological risks and control performance in non-sterile manufacturing is vitally important in the improvement of the quality and compliance of non-sterile manufacturing. Prior publications have reported the magnitude and characteristics for non-sterile product recalls and regulatory compliance shortfalls from 2004 to 2011 and from 2012 to 2019. The purpose of this review is to similarly provide a valuable contemporary update of the microbiologically related quality and compliance issues specifically associated with non-sterile drug products by reviewing drug recalls and Form FDA 483s. This includes evaluation of incidences of microbiological quality and regulatory compliance issues through more detailed abundance analysis. These data and information should assist in the risk assessment and risk management necessary in the manufacture of non-sterile products and be beneficial to the pharmaceutical microbiologist.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"567-579"},"PeriodicalIF":0.0,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146093658","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

Neural Network Prediction of Response Factors for Extractables and Leachables in Pharmaceuticals and Medical Devices. 药物和医疗器械中可萃取物和可浸物响应因子的神经网络预测。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-10-09 DOI: 10.5731/pdajpst.2025-000061.1

Yuanlin Deng, Anthony Grice, Michael Louis, Kaitlin Lerner, Kevin Rowland

{"title":"Neural Network Prediction of Response Factors for Extractables and Leachables in Pharmaceuticals and Medical Devices.","authors":"Yuanlin Deng, Anthony Grice, Michael Louis, Kaitlin Lerner, Kevin Rowland","doi":"10.5731/pdajpst.2025-000061.1","DOIUrl":"10.5731/pdajpst.2025-000061.1","url":null,"abstract":"Ensuring the safety of patients using pharmaceuticals and medical devices through chemical characterization requires accurate estimation of extractables and leachables to ensure tolerable risk from unintentional exposure to these chemicals. However, this is complicated by variability in chemical responses, particularly with mass spectrometry methods. High-quality relative response factor predictions provide the opportunity for both expedited and more accurate quantitation in extractables and leachables analyses. In-silico prediction models were developed to test a wide variety of compounds, which were selected utilizing a physicochemical property coverage approach. Three neural network models and their associated sub-models were applied to both positive and negative ionization modes for liquid chromatography mass spectrometry and gas chromatography mass spectrometry methods. Mean absolute errors across all methods were 0.47 for training data and 0.65 for out-of-sample data, indicating high predictability of response factors for the compounds chosen by the model and a low likelihood that the data were overfit. Model performance was evaluated using a series of chemicals outside the training data set. When tested, predictive accuracy was greater than 60% of known values for 44 of the 49 chemicals tested (90%), and direct comparison to an expert judgment approach that uses surrogates shows the predictions outperform that approach. This proof-of-concept work shows that sophisticated neural network modeling of response factor data is a potential solution for response factor variation.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"530-544"},"PeriodicalIF":0.0,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146093684","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

AI and ATMP: Patients First. 人工智能和ATMP：患者至上。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-10-09 DOI: 10.5731/pdajpst.2025-000052.1

Toni Manzano, William Whitford

引用次数: 0

PAT Implementation-Managing the Transition from Traditional Environmental Monitoring to In-Process Control of Aseptically Filled Products. PAT实施-管理无菌灌装产品从传统环境监测到过程控制的转变。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-10-09 DOI: 10.5731/pdajpst.2025-000044.1

Tony Cundell

引用次数: 0

Expanding the Scope of Viral Safety: Integrating Scientific Innovation, Regulatory Evolution, and Evolving Manufacturing Strategies. 扩大病毒安全性的范围：整合科学创新、监管演变和不断发展的制造策略。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-10-09 DOI: 10.5731/pdajpst.2026.26505

Chakameh Azimpour

{"title":"Expanding the Scope of Viral Safety: Integrating Scientific Innovation, Regulatory Evolution, and Evolving Manufacturing Strategies.","authors":"Chakameh Azimpour","doi":"10.5731/pdajpst.2026.26505","DOIUrl":"10.5731/pdajpst.2026.26505","url":null,"abstract":"The 2026 PDA Virus Conference, held on 22-23 June 2026 in Vienna, Austria, convened scientists from industry, regulatory agencies, academia, and technology providers to examine the changing landscape of viral safety in biopharmaceutical manufacturing. Against the backdrop of the finalized ICH Q5A(R2) guideline and the continued diversification of biologic modalities, the meeting highlighted a shift from predominantly product-specific approaches toward more integrated, knowledge-driven strategies for viral risk management (1, 2).Across the scientific sessions and structured breakout discussions, recurring themes included implementation of lifecycle approaches to viral safety; scientifically justified use of prior knowledge; optimization of established virus filtration and inactivation technologies for intensified and continuous manufacturing; and broader adoption of molecular methods, particularly next-generation sequencing (NGS), for adventitious virus detection. Presentations also addressed the distinct challenges associated with advanced therapeutic modalities, multi-product facilities, alternative expression systems, and preparedness for emerging viral threats.Collectively, the conference portrayed viral safety as an integrated discipline linking patient protection, process understanding, analytical innovation, risk assessment, and lifecycle management. This proceedings article synthesizes the principal scientific themes and areas of emerging agreement rather than providing a verbatim account of individual presentations. Continued collaboration among manufacturers, regulators, technology providers, and academic researchers will be essential to translate these advances into harmonized, risk-based practice.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 5","pages":"587-597"},"PeriodicalIF":0.0,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149148998","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

Recommendations to Streamline and Optimize USP Sterilization Informational Chapters: PDA Comments to USP <1229> and <1229.1>. 简化和优化USP灭菌信息章节的建议：PDA对USP的评论和。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-10-09 DOI: 10.5731/pdajpst.2026-000088.1

Michael Sadowski, Kenneth Paddock, Arnan Ben-David, Tiffany Bullock, Declan Fogarty, Matt Hofacre, Peryer Eric

{"title":"Recommendations to Streamline and Optimize USP Sterilization Informational Chapters: PDA Comments to USP <1229> and <1229.1>.","authors":"Michael Sadowski, Kenneth Paddock, Arnan Ben-David, Tiffany Bullock, Declan Fogarty, Matt Hofacre, Peryer Eric","doi":"10.5731/pdajpst.2026-000088.1","DOIUrl":"10.5731/pdajpst.2026-000088.1","url":null,"abstract":"This paper reviews USP's proposed consolidation of sterilization informational chapters, particularly revised USP <1229> and <1229.1>, concluding that it creates significant technical gaps and perpetuates redundancies and areas of misalignment with established global standards and guidances for moist heat sterilization. While USP's general goal of streamlining is supported, the revised chapters provide far less depth than ISO 17665:2024 and PDA Technical Reports No. 1 and No. 48, omitting or insufficiently addressing key lifecycle elements such as installation qualification, operational qualification, cycle development, performance qualification, and ongoing control, as well as other critical topics such as steam quality, biological indicator use, and process lethality. The paper recommends that USP maintain <1229> as an overarching sterilization chapter, delete modality-specific chapters, and instead cross-reference recognized global standards and guidance documents for detailed technical recommendations, thereby improving scientific alignment, reducing duplication, supporting regulatory expectations, and making USP sterilization guidance more practical and useful for sterility assurance professionals.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"655-666"},"PeriodicalIF":0.0,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148765129","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