Quality Assurance Journal最新文献

A Risk Assessment Approach: Qualification of a HVAC System in Aseptic Processing Area Using Building Management System 一种风险评估方法:利用建筑管理系统对无菌加工区域的暖通空调系统进行鉴定

Quality Assurance Journal Pub Date : 2011-07-01 DOI: 10.1002/QAJ.485

Anil Kumar Shukla, Ashutosh Katole, N. Jain, C. Karthikeyan, F. Mehta, P. Trivedi

{"title":"A Risk Assessment Approach: Qualification of a HVAC System in Aseptic Processing Area Using Building Management System","authors":"Anil Kumar Shukla, Ashutosh Katole, N. Jain, C. Karthikeyan, F. Mehta, P. Trivedi","doi":"10.1002/QAJ.485","DOIUrl":"https://doi.org/10.1002/QAJ.485","url":null,"abstract":"In the pharmaceutical industry qualification of HVAC systems is done by using a risk based approach. Failure mode effect analysis (FMEA) concepts were used for risk assessment of a HVAC system to determine the scope and extent of qualification and validation in this present work. The HVAC is the “direct impact” system in the aseptic practice which directly affects the product quality and regulatory compliance. The level of risk associated with the HVAC system was assessed based on the impact and severity of the probable risk in aseptic practice in sterile manufacturing. On completion of the risk assessment, control and measures developed and recommended actions for unacceptable risk were identified for improved cGMP compliance and qualification of the system upgrades. After completion of the risk assessment the recommended actions were extended and verified against the qualification stages of the HVAC system. Finally, the HVAC system was subjected to a performance qualification (PQ) study. All of the tests were performed and a report was generated. On evaluation of the data collected during PQ, it was found that the HVAC system met all the specified design criteria and complied with the entire cGMP requirement. Hence the system stands validated for PQ. Copyright © 2011 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"8 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2011-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114336172","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: 6

Competitiveness of Bioanalytical Laboratories— Technical and Regulatory Perspectives 生物分析实验室的竞争力-技术和法规的观点

Quality Assurance Journal Pub Date : 2011-07-01 DOI: 10.1002/QAJ.478

Michael Zhou

引用次数: 2

Principles and Practices of Analytical Method Validation: Validation of Analytical Methods is Time‐consuming but Essential 分析方法验证的原则和实践:分析方法的验证是费时但必要的

Quality Assurance Journal Pub Date : 2011-07-01 DOI: 10.1002/QAJ.477

Chung Chow Chan

引用次数: 3

Lean Techniques: The QC Lab can Reduce Product Lead Times 精益技术:QC实验室可以缩短产品交货期

Quality Assurance Journal Pub Date : 2011-07-01 DOI: 10.1002/QAJ.479

T. Dewit

引用次数: 5

ISO 22000/HACCP Associated with the Presence of Microorganisms in the Processing of Tilapia (Oreochromis niloticus) Fillets 与罗非鱼(Oreochromis niloticus)鱼片加工中微生物存在相关的ISO 22000/HACCP

Quality Assurance Journal Pub Date : 2011-07-01 DOI: 10.1002/QAJ.489

N. Carbonera, Bianca Martins Cappelletti, M. E. Santo

{"title":"ISO 22000/HACCP Associated with the Presence of Microorganisms in the Processing of Tilapia (Oreochromis niloticus) Fillets","authors":"N. Carbonera, Bianca Martins Cappelletti, M. E. Santo","doi":"10.1002/QAJ.489","DOIUrl":"https://doi.org/10.1002/QAJ.489","url":null,"abstract":"Summary \u0000 \u0000Pseudomonas is one among the many bacteria that contribute to the deterioration of fish. Other microorganisms such as Salmonella sp., coagulase positive Staphylococcus and thermotolerant coliforms can also be found. The presence of this microbiota is always related to raw materials, poor handling, or badly designed plants. In this study the presence of these indicators was evaluated. The monitoring was conducted during the reception of the fish, chilling and storage of the product at −18 °C. As part of the monitoring, preventive measures for each Critical Control Point associated with the program of Hazard Analysis and Critical Control Point were established. The results showed that there was significant difference (p < 0.05) between the samples. The resistance of these microorganisms involved in getting the frozen fillets confirmed the need for more effective control and should be subject to a regulatory program like ISO 22000. This program specifies the requirements needed for a system that can monitor and master hazards and ensure that food is safe for human consumption. Copyright © 2011 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"46 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2011-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122911923","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: 4

FDA Warning Letter: Avoidance and Advice FDA警告信:避免和建议

Quality Assurance Journal Pub Date : 2011-07-01 DOI: 10.1002/QAJ.488

T. Winchell

引用次数: 1

Advanced Process Control 先进的过程控制

Quality Assurance Journal Pub Date : 2010-07-01 DOI: 10.1002/QAJ.472

M. Moshgbar, S. Hammond

引用次数: 2

Qualifying Analytical Instruments: General Chapter Clarifies Terminology, Classifies Instruments 合格分析仪器:通论澄清术语，分类仪器

Quality Assurance Journal Pub Date : 2010-07-01 DOI: 10.1002/qaj.475

L. Valigra