PDA Journal of Pharmaceutical Science and Technology最新文献_第10页

Bridging Guidance and Regulation: Interpreting the Draft Annex 22 on Artificial Intelligence in GMP Manufacturing. 衔接指南与法规：解读GMP生产中的人工智能附录22草案。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-04-10 DOI: 10.5731/pdajpst.2025-000076.1

Mario Stassen, Matt Schmucki, Francisco Valero, Toni Manzano

{"title":"Bridging Guidance and Regulation: Interpreting the Draft Annex 22 on Artificial Intelligence in GMP Manufacturing.","authors":"Mario Stassen, Matt Schmucki, Francisco Valero, Toni Manzano","doi":"10.5731/pdajpst.2025-000076.1","DOIUrl":"10.5731/pdajpst.2025-000076.1","url":null,"abstract":"This paper builds upon Stassen et al. (2025), \"Recommendations for Artificial Intelligence Application in Continued Process Verification,\" to provide a detailed interpretation of the European Medicines Agency (EMA) Draft Annex 22-Artificial Intelligence (July 2025 draft) within the context of GMP-regulated pharmaceutical manufacturing. The draft annex introduces a structured, risk-based framework for artificial intelligence (AI) adoption, defining expectations for intended use, validation, life cycle management, explainability, and human-in-the-loop (HITL) oversight. This manuscript examines the alignment between Annex 22 provisions and continued process verification (CPV) recommendations, identifies convergence, operational challenges, and areas for future development, and proposes a roadmap for compliant AI implementation. Conceptual frameworks and workflow illustrations depict the harmonization of CPV principles, life cycle management, and emerging regulatory expectations. This review supports harmonized AI governance and readiness for Annex 22 compliance across the pharmaceutical sector.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"248-254"},"PeriodicalIF":0.0,"publicationDate":"2026-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146207298","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

Does Disinfection Influence your Environmental Monitoring Data or Does your Environmental Monitoring Data Influence your Disinfection Protocols? Poster presented at PDA Microbiology Conference 2025. 消毒会影响你的环境监测数据还是环境监测数据会影响你的消毒方案？在PDA微生物学会议2025上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26112

Nyssa-Marie Finegan

引用次数: 0

Evaluation of The Mango System for Rapid Recovery of Microorganisms: Poster presented at PDA Microbiology Conference 2025. 芒果系统对微生物快速回收的评估：在2025年PDA微生物学会议上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26117

Lia Jeffrey, Krzysztof Paczesny, Lara Pebley, Christopher Burgos, Lovette Jenkins, Jessica Hankins, Amy McDaniel

{"title":"Evaluation of The Mango System for Rapid Recovery of Microorganisms: Poster presented at PDA Microbiology Conference 2025.","authors":"Lia Jeffrey, Krzysztof Paczesny, Lara Pebley, Christopher Burgos, Lovette Jenkins, Jessica Hankins, Amy McDaniel","doi":"10.5731/pdajpst.2026.26117","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26117","url":null,"abstract":"The Mango system was evaluated by spiking Fluid A with seven different microorganisms: Clostridium sporogenes ATCC 11437, Cutibacterium acnes ATCC 6919, Staphylococcus aureus ATCC 6538, Bacillus spizizenii ATCC 6633, Aspergillus brasiliensis ATCC 16404, Pseudomonas paraeruginosa ATCC 9027, and Candida albicans ATCC 10231. For each microorganism, two replicates were prepared on spread plates, Oasis TSA cartridges, and Mango Cartridges. Each microorganism was tested three times by three different analysts. The inoculated control plates (Oasis and spread plates onto TSA medium) were incubated at 30-35°C for 24h to 7 days. The Mango test plates were incubated for 16-160h.The study provides comparative data on the time to detection and recovery rates for the tested microorganisms. The results indicated that the Mango system consistently showed faster time to detection for aerobic organisms than traditional methods, however incubation time and conditions were microorganism-dependent, particularly for anaerobic bacteria such as C. sporogenes and C. acnes. In addition, this study showed that the rates of recovery between the Mango and traditional systems were equivalent and provides data on the filterability of different matrices. The findings indicate that the Mango system has potential to rapidly and consistently recovery microorganisms from biopharmaceutical samples.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"155-156"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147321935","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

Detection of Bacillus Subtilis Endopores Using an Online Water Bioburden Analyzer: Poster presented at PDA Microbiology Conference 2025. 使用在线水生物负荷分析仪检测枯草芽孢杆菌内孔：在PDA微生物学会议2025上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26129

Kim Perkins, Amanda Picazzo, Deja Van Vliet

{"title":"Detection of Bacillus Subtilis Endopores Using an Online Water Bioburden Analyzer: Poster presented at PDA Microbiology Conference 2025.","authors":"Kim Perkins, Amanda Picazzo, Deja Van Vliet","doi":"10.5731/pdajpst.2026.26129","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26129","url":null,"abstract":"Bacterial endospores represent a significant challenge to the pharmaceutical industry due to their presence in the environment, resistance to many commonly used inactivation procedures, and difficulty in culturing using traditional plating methods. This may result in the inadvertent release of contaminated products that may present health concerns for the patient. As a result, the use of a bio-fluorescent particle counter (BFPC) may prove advantageous for the detection of both water-borne and air-borne spores as their detection is not dependent on traditional culturing methods. In this study, we investigate the ability of an online water bioburden analyzer (OWBA), a specific class of BFPC, to detect Bacillus subtilis spores in pharmaceutical-grade water and present the results as auto-fluorescence units (AFU's) per B. subtilis spore. The spores were a commercial grade spore preparation and were previously quantified per manufacture recommendations. The results show that the OWBA can detect B. subtilis spores with an accuracy of 1.25 AFU per spore. The limit of detection was determined to be 1 spore/mL with a linearity greater than 0.9025 up to a concentration of 100 spores/mL. This data shows that OWBA's are a rapid and effective tool for the detection of bacterial endospores in pharmaceutical waters.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"179-180"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147322013","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 the Impacts and Science Behind Disinfectant Residue: Poster presented at PDA Microbiology Conference 2025. 了解消毒剂残留背后的影响和科学：在2025年PDA微生物会议上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26120

Dan Klein

引用次数: 0

2025 in Review. 回顾2025年。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.02611

引用次数: 0

Automating Endotoxin Testing in a GMP Environment: Poster Presented at PDA Microbiology Conference 2025. 自动化内毒素检测在GMP环境：海报提交在PDA微生物会议2025。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26139

Katharina Stoib

引用次数: 0

Eyes on the prize: How Many Eyes are too Many for Microbiological Data Integrity? Poster presented at PDA Microbiology Conference 2025. 关注奖项：多少人对微生物数据的完整性来说太过分了？在PDA微生物学会议2025上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26116

Christine Jackson, Stephanie Chmura Callahan, Mariana Breña, Liz Tirado

{"title":"Eyes on the prize: How Many Eyes are too Many for Microbiological Data Integrity? Poster presented at PDA Microbiology Conference 2025.","authors":"Christine Jackson, Stephanie Chmura Callahan, Mariana Breña, Liz Tirado","doi":"10.5731/pdajpst.2026.26116","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26116","url":null,"abstract":"In microbiological quality control, manual observations-such as colony counts, Gram stains, and growth assessments-play a critical role in ensuring product safety and compliance. Data integrity is a key issue, with the frequency of warning letters rising annually. To determine the appropriateness of a single manual observation, it is essential to assess the risk. Cambrex conducted a formal risk assessment using the Failure Mode and Effects Analysis (FMEA) tool to evaluate manual observations in microbiology. The risk question posed was: 'What is the risk to patient safety and to cGMP decisions if a second analyst verification is not performed on manual microbial observations?'. The analysis considered key risk factors including observation complexity, analyst competency, historical deviation trends, and the potential impact on product quality and patient safety. Controls such as standardized training, competency assessments, and procedural enhancements were assessed for their ability to mitigate associated risks. Cambrex assessed the feasibility of implementing a streamlined review process in specific scenarios, ensuring compliance with Good Manufacturing Practices (GMP) while maintaining the reliability of microbiological data. Interestingly, medical device bioburden enumeration from a single manual observation was deemed low risk whereas pharmaceutical product bioburden necessitated a second analyst verification.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"153-154"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147321884","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

Aseptic Process Challenges: The Threat of Underperforming Disinfectants for cGMP Applications: Poster Presented at PDA Microbiology Conference 2025. 无菌工艺挑战：cGMP应用中表现不佳的消毒剂的威胁：2025年PDA微生物学会议上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26110

Omar Cruz

引用次数: 0

From Bench to Reality: The Role of Natural Contaminations in LER Investigations: Poster presented at PDA Microbiology Conference 2025. 从工作台到现实：自然污染在LER调查中的作用：海报呈现在PDA微生物会议2025。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26128

Alessandro Pauletto, Christian Faderl, Luca Di Bello, Gregory Devulder, Kevin L Williams

引用次数: 0