Quality assurance of computer systems what is needed to comply with ISO 9000, GMP,GLP, and GCP?

This paper will interpret the application of the different quality standards like Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and ISO 9000-3 guidelines to computer systems. The ISO 9000-3 contains requirements for developing software, whereas the GxPs have more detailed requirements for use. ISO 9000-3 can be used profitably as a tool for the GxPs. The standards often have vague demands which need to be interpreted. The wordings of the standards are compared to current interpreted requirements. Tables for comparison of the wording of the standards are also included.     

Does Accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) Ensure Greater Compliance With Animal Welfare Laws?

Accreditation of nonhuman animal research facilities by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) is widely considered the “gold standard” of commitment to the well being of nonhuman animals used in research. AAALAC-accredited facilities receive preferential treatment from funding agencies and are viewed favorably by the general public. Thus, it bears investigating how well these facilities comply with U.S. animal research regulations. In this study, the incidences of noncompliance with the Animal Welfare Act (AWA) at AAALAC-accredited facilities were evaluated and compared to those at nonaccredited institutions during a period of 2 years. The analysis revealed that AAALAC-accredited facilities were frequently cited for AWA noncompliance items (NCIs). Controlling for the number of animals at each facility, AAALAC-accredited sites had significantly more AWA NCIs on average compared with nonaccredited sites. AAALAC-accredited sites also had more NCIs related to improper veterinary care, personnel qualifications, and animal husbandry. These results demonstrate that AAALAC accreditation does not improve compliance with regulations governing the treatment of animals in laboratories.     

Assessing animal care and use programs internationally

As international collaborations become commonplace, new issues arise concerning the potentially variable quality of laboratory animals. The Associate Director and the Director of AAALAC International discuss efforts to harmonize facility procedures and practices of animal care and use globally.     

Bacteriophage therapy--cooked goose or phoenix rising?

Recent animal and human trials of bacteriophage therapy have demonstrated its potential to alleviate bacterial diseases, both in internal and in external applications. The regulatory requirements are becoming clearer as more examples are presented. A core of GLP (Good Laboratory Practice) studies will be needed to validate safety and clinical trials to validate efficacy. GMP (Good Manufacturing Practice) production requirements and quality issues will mean that comparable costs to the production of conventional antibiotics should be anticipated. The definition of the 'active substance' will be central to the success of bacteriophage therapy to ensure that the variety and evolutionary potential of bacteriophages are exploited.     

A truly global career

An interview with Kathryn Bayne, MS, PhD, DVM, DACLAM, CAAB, Global Director, Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International, Frederick, MD.     

Integrated data acquisition system for medical device testing and physiology research in compliance with good laboratory practices

In seeking approval from the US Food and Drug Administration (FDA) for clinical trial evaluation of an experimental medical device, a sponsor is required to submit experimental findings and support documentation to demonstrate device safety and efficacy that are in compliance with Good Laboratory Practices (GLP). The objective of this project was to develop an integrated data acquisition (DAQ) system and documentation strategy for monitoring and recording physiological data when testing medical devices in accordance with GLP guidelines mandated by the FDA. Data aquisition systems were developed as stand-alone instrumentation racks containing transducer amplifiers and signal processors, analog-to-digital converters for data storage, visual display and graphical user-interfaces, power conditioners, and test measurement devices. Engineering standard operating procedures (SOP) were developed to provide a written step-by-step process for calibrating, validating, and certifying each individual instrumentation unit and the integrated DAQ system. Engineering staff received GLP and SOP training and then completed the calibration, validation, and certification process for the individual instrumentation components and integrated DAQ system. Eight integrated DAQ systems have been successfully developed that were inspected by regulatory affairs consultants and determined to meet GLP guidelines. Two of these DAQ systems were used to support 40 of the pre-clinical animal studies evaluating the AbiCor artificial heart (ABIOMED, Danvers, MA). Based in part on these pre-clinical animal data, the AbioCor clinical trials began in July 2001. The process of developing integrated DAQ systems, SOP, and the validation and certification methods used to ensure GLP compliance are presented in this article.     

GLP原则在体外毒理学评价实验室的应用

在动物福利运动的推动下,以减少、优化和替代动物试验为核心内容的体外试验系统已成为安全评价不可或缺的组成部分,在药品、化学品、化妆品毒理学评价中起到重要作用。体外试验系统不同于体内动物实验,体外毒理学实验室GLP原则的建立和运行应充分考虑体外试验系统的特殊性。目前我国专业的体外安全评价实验室的建设刚刚起步,还没有可供借鉴的成熟经验。本文从实验室组织、试验系统维护、人员职责、质量管理和运行几个方面,介绍了GLP原则在化妆品体外毒理学检验和评价实验室的应用。     

“创新药物研发高层论坛”专家观点

对2015年1月30日召开的“创新药物研发高层论坛”的专家报告内容进行归纳总结,旨在为从事药品注册、创新药及仿制药研发、 药物临床试验质量管理规范（GCP）及药品非临床研究质量管理规范（GLP）工作的人士提供信息参考。     

Fundamental training for individuals involved in the care and use of laboratory animals: a review and update of the 1991 NRC Core Training Module

Public trust demands that individuals who do research, testing, or teaching with animals use humane, ethical, and scientifically sound methods. Furthermore, the Animal Welfare Act and the Public Health Service Policy require research institutions to provide basic training and to ensure that anyone who cares for and/or works with laboratory animals has the appropriate training or experience relevant to their job responsibilities. Institutions accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International must also provide training programs and ensure the qualifications of personnel. The primary goal of this training is to provide individuals with basic knowledge and to reinforce attitudes and behaviors that help to ensure humane animal care and use. This article provides an overview of the core training module outline and content from the 1991 report of the Institute for Laboratory Animal Research, Education and Training in the Care and Use of Laboratory Animals: A Guide for Developing Institutional Programs, as well as pertinent updates for introducing personnel to information regarding the care and use of laboratory animals. Both mandatory and suggested training topics are reviewed, including relevant regulations and standards, ethical considerations, humane methods of animal experimentation and maintenance, and other pertinent topics. Although the fundamental training course content and delivery will vary depending on the nature and complexity of an institution's animal care and use program, this basic training provides the foundation for more in-depth training programs and supports humane and ethical animal care and use.     

Laboratory software validation — from corporate policy to bench top systems

This tutorial presents a practical approach to implementing computer validation across a whole laboratory organization. It discusses the types of policies and practices which need to exist in order to meet both business and regulatory needs in the multi-system, multi-department laboratory workplace. It advocates the use of international standards (IEEE, ISO) and global regulations (GLP, GCP, GMP, CANDA) for validation activities and documentation. Experience has shown the approach to be useful in many companies and in many countries.     

Validation of quantitative liquid chromatography—mass spectrometry software for good laboratory practice compliance

The application of the UK Department of Health Good Laboratory Practice (GLP) guidelines to computer systems is discussed including the scope of an inspection of a computer system for compliance. A validation case history of software for quantitative liquid chromatography—mass spectrometry is reviewed including generation of the validation test plan and brief details of the validation tests performed. Tests for system security, sample continuity, accuracy of integration, accuracy of calibration, and integrity of data exported from the system are described..     

The role of SSDL in quality assurance in radiotherapy

This paper describes the role of the Polish Secondary Standard Dosimetry Laboratory (SSDL) in quality assurance in radiotherapy by means of providing calibration of ionisation chambers, TLD postal dosimetry audits and end-to-end audits for radiation therapy. A historical review of the methods and results are presented. The influence of the SSDL in Warsaw on radiation protection of patients in Poland is discussed. The International Atomic Energy Agency together with World Health Organisation (IAEA/WHO), through its network of SSDLs around the world, propagates newly developed methods for calibration and auditing. Suitable high quality equipment was provided by the IAEA, as well as special materials and technical support to the SSDL in Warsaw. The activity of the SSDL and the services provided for Polish radiotherapy centres have resulted in a reduction of discrepancies between planned doses and doses delivered to patients. The newly tested IAEA methods of end-to-end on-site dosimetry audits allow for monitoring and improving the quality of IMRT in Poland. The traceability of standards used for the calibration of therapy level dosimeters from Polish radiotherapy centres is assured by the IAEA dosimetry laboratory. The consistency of methods performed in the Polish SSDL with the ISO:17025 norm is supervised by the Polish Centre for Accreditation – a member of International Laboratory Accreditation Cooperation (ILAC), for calibration and testing. Due to the rapid technological development of radiotherapy, special attention has to be paid to newly developed methods for dosimetry auditing and institutions which provide services for assuring radiation safety of patients.     

Use of positive reinforcement training in the management of species for reproduction

Positive reinforcement training holds great potential for enhancing the management of species for reproduction. This paper reviews a wide range of animal training activities and resultant benefits which could have application to captive reproduction programs. Recognized benefits fall into several categories. Basic animal care can be improved through voluntary cooperation by the animals with veterinary procedures and routine husbandry activities. The quality and quantity of physiological data collected for research can be improved through voluntary cooperation by the animal subjects with sample collection. Positive social interaction and reproductive behavior can be increased and aggressive behavior reduced through employment of a specialized training regime called cooperative feeding. Good success has been reported with special training programs to facilitate introduction of new members into primate social groups, while mixed results have been obtained in efforts to use training to enhance maternal skills. Finally, a discussion of both direct and indirect enhancement of psychological well-being through the use of positive reinforcement training is presented. While positive reinforcement training techniques will not be useful in every situation, information developed to date strongly suggests that these techniques should be given serious consideration when developing comprehensive programs for the management of species for reproduction. © 1994 Wiley-Liss, Inc.     

A broader view of validation; the balance of compliance and science

Validation is discussed in terms of the business environment and its implementation as a balance between the requirements of science and compliance. “Top down” and “Bottom up” methods are discussed in the light of current regulatory practices of ISO, NAMAS, GLP, and GMP etc. A framework is proposed to allow a common sense approach to validation programmes.     

规范实验动物设施管理,提高科研服务质量

实验动物设施是医院科学研究的技术平台。如何利用有限的资源,全面提高实验动物中心科研服务水平是管理者亟待解决的问题。本文通过总结第四军医大学口腔医院实验动物中心的规范化建设及管理,探索提高实验动物中心运行效率和科研服务质量的方法。     

The case for genetic monitoring of mice and rats used in biomedical research

Currently, there is the potential to generate over 200,000 mutant mouse strains between existing mouse strains (over 24,000) and genetically modified mouse embryonic stem cells (over 209,000) that have been entered into the International Mouse Strain Resource Center (IMSR) from laboratories and repositories all over the world. The number of rat strains is also increasing exponentially. These mouse and rat mutants are a tremendous genetic resource; however, the awareness of their genetic integrity such as genetic background and genotyping of these models is not always carefully monitored. In this review, we make a case for the International Council for Laboratory Animal Science (ICLAS), which is interested in promoting and helping academic institutions develop a genetic monitoring program to bring a level of genetic quality assurance into the scientific interchange and use of mouse and rat genetically mutant models.     

Effects of housing density on nasal pathology of breeding mice housed in individually ventilated cages

The 2011 edition of the Guide for the Care and Use of Laboratory Animals includes new recommendations for the amount of floor space that should be provided to breeding mice. When pairs or trios of continuously breeding mice are housed in shoebox cages, they may have less than this recommended amount of floor space. High housing densities may adversely affect animal health, for example, by compromising air quality inside the cage. Hence, some institutions are carefully reevaluating the microenvironments of breeding cages. The use of individually ventilated cages (IVCs) to house research mice allows for greater control over the quality of the cage microenvironment. The authors evaluated the microenvironments of shoebox cages in an IVC rack system housing breeding and non-breeding Swiss Webster mice. Ammonia concentrations were significantly higher in cages housing breeding trios with two litters. Histopathologic lesions attributable to inhaled irritants such as ammonia were found in mice housed in breeding pairs and trios. The authors conclude that the microenvironments of cages in an IVC rack system housing breeding pairs and trios may be detrimental to animal health.     

Application of good laboratory practice (GLP) to culture collections of microbial and cell cultures

Although the principles and the necessity for good laboratory practice (GLP) guidelines to confirm the credibility, integrity, and quality of non-clinical laboratory studies have been known for more than a decade, culture collection activities are not subject to them. Because of recent advances in biotechnology, culture collections face increased demands not only for quality cultures but also current information. When applied in culture collections, GLP guidelines prove to be an excellent management tool as well as a cost-effective system of providing authentic and reliable microbial and cell cultures and associated data.     

News from the Biological Stain Commission No. 7

Abstract

In this issue of News from the Biological Stain Commission (BSC), under the heading of Regulatory affairs, the Biological Stain Commission's International Affairs Committee presents information from a meeting held in Berlin by the International Standards Organization ISO/TC 212/WG 1, “Quality and Competence in the Medical Laboratory,” on 11–12 December 2008. After this, we turn again to problems with impure dyes and find that solvent dyes are impure even for non-biological use.     

Implementation of a Quality Plan (ISO 9002) In a Regional Tissue Bank

Quality control and standardized preservation methods are essential in the field of transplantation. The International Organization for Standardization (ISO) has established a common set of manufacturing, trade and communications standards that are applicable worldwide and that provide the basis of a quality plan for Tissuebreak Banks.The Sectorial Tissue Banking (STB) of the Regional Blood Transfusion Center (RBTC) of Córdoba (Spain) is a non-profit-making tissue bank, established in 1992 to provide tissues for surgical procedures to the hospitals in a regional area. In 1998, the STB as a part of the RBTC embarked upon the path of becoming ISO-certified: after two years of the implementation of the project, STB attained ISO 9002 certification, thus becoming one of the first tissue banks in Europe to achieve this qualification. In this paper we describe the process of becoming ISO-certified, to demonstrate the positive impact that it has had on our entire organization.The assistance of an outside consultant who provided the necessary information for implementing an ISO quality management system was required. The initial improvement was: a well-defined quality manual to address all elements of the ISO 9002 standard, an improved document control system, detailed standard operating procedures (SOPs) and improved employees training processes. A quality committee team and developed quality indicators were created. The internal quality auditing program was established by the selection of employees from a cross-section of the organization, who were trained in internal auditing processes. A formal corrective action system was developed and implemented to facilitate process improvement. The consultant conducted a pre-certification audit, and one month later the certification audit was performed.In conclusion, the implementation of an ISO quality program in the STB has helped our center to establish a control process in the manufacturing of products and services to meet the expectations of our customers, by providing components and services that comply with the national regulatory standards and requirements.