共查询到20条相似文献,搜索用时 15 毫秒
1.
《Pharmaceutica acta Helvetiae》1997,72(6):349-356
The advantages of customized Laboratory Information Management's Systems (LIMS) are their focus on the special aspects of their users' needs. Differences in the research and development or production chain in the individual organizations lead to an increase of interest in customized systems. Usually, also for customized systems, the core software is commercially available. The individual application modules as the customized part of the LIMS are the most critical elements within the validation process. The topic of this paper is to give an example of the validation of a customized analytical LIMS. Validation of complex computerized systems guarantees the intended use and is therefore an unavoidable requirement of authorities. The audit of the supplier of the individual programmed modules, the user requirement specifications and the acceptance testing and results, respectively, on the software are of special interest within a customized LIMS. The hardware suitability and the principal processing routines are also a very important part of the whole validation process, but they will not be discussed in detail in this paper. 相似文献
2.
《Pharmaceutica acta Helvetiae》1997,72(6):343-348
In recent years the introduction of computer systems for data handling in the pharmaceutical industry has increased. A standard LIMS (laboratory information management system) is software commercially available from different suppliers not only to facilitate data handling in laboratories but also to cover GMP-requirements. Computer systems introduced in GMP-areas of pharmaceutical companies have to be validated. For a standard LIMS, the general validation of the program is performed by the supplier. Nevertheless, the user is always required to cover all phases of a validation. The objective of this paper is to discuss suitable test procedures for the most critical functions of a standard LIMS needed during the verification step of the validation process. 相似文献
3.
McDowall R 《Bioanalysis》2011,3(13):1487-1499
Computerized system validation is often viewed as a burden and a waste of time to meet regulatory requirements. This article presents a different approach by looking at validation in a bioanalytical laboratory from the business benefits that computer validation can bring. Ask yourself the question, have you ever bought a computerized system that did not meet your initial expectations? This article will look at understanding the process to be automated, the paper to be eliminated and the records to be signed to meet the requirements of the GLP or GCP and Part 11 regulations. This paper will only consider commercial nonconfigurable and configurable software such as plate readers and LC-MS/MS data systems rather than LIMS or custom applications. Two streamlined life cycle models are presented. The first one consists of a single document for validation of nonconfigurable software. The second is for configurable software and is a five-stage model that avoids the need to write functional and design specifications. Both models are aimed at managing the risk each type of software poses whist reducing the amount of documented evidence required for validation. 相似文献
4.
McDowall RD Pearce JC Murkitt GS 《Journal of pharmaceutical and biomedical analysis》1988,6(4):339-359
The purpose of this analytical survey is to give a summary of some of the main design features that can be incorporated into a Laboratory Information Management System (LIMS), in the context of the total automation of the laboratory. Additionally it will give potential purchasers of such systems some essential background knowledge and a summary of our experiences. The survey is presented in two parts: the first covers the features and the possible concepts that could be used in a LIMS system. This is followed in the second part by an outline of the stages of acquisition, validation and benefits of such a system. Together the two articles provide the information required to aid the design and installation of a LIMS. This first section deals with the possible features that a laboratory could include when contemplating the installation of such a system: the basic tools that are required for a LIMS, the database and the computer equipment are discussed. This is followed by the interfacing of analytical instruments and central versus distributed processor philosophy. The various screen formats available and the use of bar codes as a means of identifying samples and for rapid data entry into the computer system are discussed. 相似文献
5.
6.
The use of biomarkers during clinical drug-development programs may expedite pipeline decision making by adding critical information about the pharmacological mechanism and efficacy of a potential therapeutic agent. Currently, advice for laboratorians conducting method development and analytical validation of biomarker methods is provided by published White Paper recommendations from industry thought leaders. The adaptation of commercial test kits to generate biomarker data to support regulated studies offers unique challenges and limitations. In this perspective, we address these issues, including factors to consider when identifying a kit manufacturer and adapting commercial test kits for use in regulated studies. We offer a logical and systematic approach for defining the extent of analytical validation needed for application of commercial kits based upon the intended use of the biomarker data. 相似文献
7.
Pharmacogenomics (PG) holds promise for transforming medical therapeutics but the details of how the promise will become reality are still vague. In this article, we focus on the role that laboratory medicine, as a discipline, might play in transitioning the application of pharmacogenomics into the healthcare system and begin to frame a perspective on how PG may be viewed in this context. Development of clinical diagnostic tests usually evolves as a continuum of information starting with the discovery of a potential biological marker through to its routine use in clinical practice. This process has traditionally been rooted in the practice of laboratory medicine and, importantly, includes the development of testing strategies to optimize the predictive value of single or a combination of biological markers. In this context, we also discuss a perspective on some future strategies that may prove useful in advancing the application of PG, including the need for an evidenced-based approach and the potential role of proteomics as a means to drive more comprehensive strategies. 相似文献
8.
《Pharmaceutical science & technology today》1998,1(7):300-308
Significant resources are required for the development and validation of complex processes used in the manufacture of monoclonal antibodies for clinical trials and commercial production. For those companies contemplating process validation, regulatory guidelines provide a good starting point, particularly with regard to product safety. However, these guidelines leave open the methodology required to determine suitable process limits that are essential to the validation of the robustness of the process. Using a generalized antibody manufacturing process as a guide, the authors present an approach that provides a reliable basis for process validation. Some typical pitfalls, and how these may be avoided, will be discussed for each major stage of validation. 相似文献
9.
《Fundamental and applied toxicology : official journal of the Society of Toxicology》1990,14(3):439-443
This paper presents a brief history of the evolution of toxicological information in the United States since 1966 when concern over the hazards of the ubiquitous chemicals in the environment was translated into recommendations for action by The Panel on the Handling of Toxicological Information of the President's Science Advisory Committee. It describes some of the data bases that were developed as a result of these recommendations and introduces a series of papers that discuss toxicology information resources, their content, and their accessibility. The series is a project of the Information Handling Committee of the Society of Toxicology. Papers II–V of this series will be published in subsequent issues of Fundamental and Applied Toxicology. 相似文献
10.
药检实验室信息管理系统建设思路 总被引:1,自引:1,他引:0
目的加强实验室信息化建设与管理,建立完善的质量保证体系。方法阐述了药检行业应用实验室信息管理系统的现实意义,针对提高检验业务工作规范化程度、符合质量管理体系要求、决策支持、系统整合、检验数据自动采集等本行业特点提出了系统建设的具体目标;并从开发商选择、系统选型原则、项目实施建议等方面总结了系统实施中应注意的问题。结果与结论通过LIMS系统的实施,规范了实验室的业务流程和管理体制,必将使我院的检验能力得到进一步的全面提升。 相似文献
11.
McDowall RD Pearce JC Murkitt GS 《Journal of pharmaceutical and biomedical analysis》1988,6(4):361-381
In this, the second of two articles on Laboratory Information Management Systems (LIMS), the stages of the acquisition of a system are discussed. First, the laboratory automation strategy is developed leading to the writing of the requirements specification sent to prospective suppliers. The next step, in conjunction with the chosen supplier, is to write the functional and systems specifications from which the LIMS will be tailored. Once installed the LIMS must be validated and in the event of hardware or software changes, should undergo partial or full re-validation. The education and training of users, and operational considerations are presented before concluding with possible developments of LIMS in the future. 相似文献
12.
目的探索风险管理工具在原料药工艺验证中的应用,使用失效模式和影响分析(failure mode and effects analysis,FMEA)评估关键工艺参数,降低验证风险。方法将FMEA应用于原料药的工艺验证,根据风险优先数(risk priority number,RPN)值的大小,确定关键工艺参数和风险控制措施。结果通过实施和跟踪工艺操作控制措施,再次计算RPN值,较验证前减小,降低发生工艺偏差的风险。结论质量风险管理应用于原料药工艺验证,可有效地提高针对性,降低生产质量的系统风险,将有利于日常商业化生产的平稳运行,提高生产效率。 相似文献
13.
14.
Analytical method validation is the systematic process of establishing that an analytical method is acceptable for its intended purpose. In general the developer or user of the method generates evidence on specificity, linearity range, accuracy, precision, detection limit, quantitation limit, ruggedness and robustness of the method for regulatory submissions or in-house application. The iterative process of method development and validation has a direct impact on the quality of the above data. Such validated analytical methods for qualitative or quantitative testing of drug molecules assume greater importance when they are employed to generate quality and safety compliance data during development and post-approval of drug products. The present paper aims to discuss salient points of the analytical method development and validation cycle. It also attempts to compare and summarize guidelines issued by different agencies for validation of analytical methods used for analysis of drug substances in the pure form and in pharmaceutical formulations. 相似文献
15.
《Statistics In Biopharmaceutical Research》2013,5(3):214-229
With the rapid advancement of scientific understanding in the medical field, everyday use of personalized medicine appears within our grasp. Unfortunately, there are still challenges to overcome. In many therapeutic areas, there remains a lack of deep understanding of disease processes and treatments. Additionally, drug development proceeds over a 5–10 year timeframe, during which time knowledge of treatments and potential predictive biomarkers continues to evolve. For successful development of a drug that is tailored to a biomarker-defined patient population and approved by regulators for such use, employment of appropriate statistical design and analysis methods is paramount. Consequently, statisticians can play a leading role in transforming the practice of medicine to a more personalized approach. We describe four perspectives in clinical development, together with examples of each, and discuss how to approach the problem of demonstrating that a treatment works better in a biomarker-defined subgroup of patients than in its complementary subgroup. The four perspectives provide a framework for design of clinical trials and subsequent analyses as they relate to clinical development. Subgroup identification is described as a controlled, disciplined search for finding the right patient for treatment and is distinguished from traditional, exploratory subgroup analysis. 相似文献
16.
The method validation strategy described consists of four components which are the prevalidation, validation proper, study proper and statistical analyses. These components constitute the platform upon which to evaluate the reliability and reproducibility of a bioanalytical method. Consideration has been given to emulate the study proper conditions to understand the method's limitations and performance expectations. The validation strategy will be presented in two papers. This first paper will describe the overall validation strategy, and the second paper will discuss the statistical analyses and data interpretation. 相似文献
17.
Katrin I. Tiffner Isadore Kanfer Thomas Augustin Reingard Raml Sam G. Raney Frank Sinner 《International journal of pharmaceutics》2018,535(1-2):217-227
The rate of release of an active pharmaceutical ingredient (API) from a topical semisolid dosage form can be influenced by its physical and structural properties. An In Vitro Release Test (IVRT) is an established method to characterize this rate of API release and compare the underlying sameness in product quality characteristics. The purpose of this work was to validate an IVRT method to compare acyclovir cream, 5% products. However, despite widespread use of the IVRT since 1997, there has been no established approach to validate an IVRT method. Our approach included: 1) qualification of the diffusion cell apparatus, 2) qualification of the laboratory, 3) validation of the HPLC analytical method, and 4) validation of numerous critical parameters of the IVRT method, itself, and resulted in a comprehensive and successful IVRT method validation. Subsequent to the IVRT validation work described here, the U.S. Food and Drug Administration (FDA) drafted a guidance on the development and validation of an IVRT method for acyclovir cream, 5%. Although there are notable differences between our approach and the approach in that guidance, this report illustrates how many of the same essential qualification parameters and validation concepts were considered and systematically addressed in our approach to IVRT validation. 相似文献
18.
19.
20.
目的:探讨药物安全评价研究机构对实验室信息管理系统(LIMS)实施风险评估的方法,并基于评估结果制定措施降低风险,确保研究质量。方法:采用“故障模式、影响和危害性分析”(FMECA)方法,对LIMS实施整体的风险评估。首先确定风险评估的目的、范围、依据和评估工具,并建立风险评估组织,根据风险评估流程对LIMS实施的整体合规性风险评估过程进行梳理。结果与结论:通过对系统实施的整体合规性评估明确了风险来源,发现了会影响研究质量的风险,并制定了降低风险措施以保证系统的整体合规要求,进一步提升了药物安全评价研究的数据质量。FMECA方法可应用在用于药物安全性评价研究流程中的LIMS,对提升数据质量有很好的帮助。 相似文献