失效模式与影响分析法评价药品GMP认证缺陷改正效果的探讨

目的探索质量风险管理在药品GMP认证中的应用，使用风险管理工具，指导药品GMP认证技术审评工作。方法用风险管理工具失效模式与影响分析（FMEA）法，评价企业缺陷项目改正的效果。结果和讨论使用FMEA评价整改报告，使药品GMP认证技术审查更系统化、更具科学性。     

浅谈药品生产企业新版GMP认证准备工作

GMP认证制度是国家法律性的强制要求,是药品生产企业的基本要求和生存的基础,药品生产企业顺利取得GMP认证证书至关重要。就制药企业开展GMP认证准备工作的几个环节,即从建立组织机构、厂房设施的改造、GMP文件编写、认证申报资料的编写、现场检查的准备等环节,阐述制药企业开展GMP认证准备工作中要关注的问题。     

臭氧灭菌技术--在食品加工业GMP、HACCP中的应用

美国实施GMP已有近40年的历史并在实践中做了几次修订.根据多年来在我国推行GMP和药品监督的实践和国际上实施GMP在建立统一组织机构执法方面经验,1998年我国改革并统一了药品监督的机构,新组建了<国家药品监督管理局>.同时国家药品监督管理局又于1999年新颁布了<药品生产质量管理规范(GMP1998年版)>并制定了附录.该局又印发了<药品GMP认证管理办法>和<药品GMP认证工作程序>.GMP是我国药品生产企业管理的基本法则.     

浅谈对GMP的认识

目前在国内制药企业掀起了GMP认证高潮的同时，许多食品和保健品生产厂家也在积极进行GMP认证，目的是为了提高企业产品的竞争优势。据悉，国内已经有通过GMP认证的食品企业。笔者根据在药品企业进行GMP认证工作的浅薄经验谈谈对GMP的认识。     

风险评估在药品质量管理中的应用

随着我国药品质量控制工作的不断深入,对市场上流通药品的潜在安全风险越来越受到人们的关注。为了减少药品不良反应事件的发生,我国2010年修订版GMP要求对药品质量管理采取风险管理。风险评估作为风险管理中的一部分,对其要求也是非常严格的。针对药品质量风险管理的阶段进行分析,探讨风险管理在药品质量管理中的应用。     

浅谈制药企业GMP认证对仓库管理的要求

GMP是《药品生产质量管理规范》的英文缩写,它是保障药品生产达到规定标准的行为准则。制药企业GMP仓库管理是指与药品生产所需要的原辅料、包装材料,以及生产制造出来的中间产品、产成品从入库到出库所涉及的一系列相关工作内容。文章主要探讨GMP标准对制药企业GMP认证仓库管理方面的要求。     

FMEA在卷包工序产品品质风险管理中的应用

为更好地控制生产过程中卷烟产品品质,根据卷包工序的生产特点和卷烟产品品质要求,将FMEA(Failure Mode and Effects Analysis)风险评估技术应用于卷包工序产品品质风险管理。通过对各风险因素进行风险排序,确定需要重点关注的风险因素,得出卷烟产品品质风险管理的FMEA风险评价方法,并构建了卷包工序产品品质风险管理FMEA模式。结果表明:在卷包工序实施FMEA产品品质风险管理,能够全流程识别产品品质风险点并进行控制,有效降低了产品品质风险,减少了生产成本,卷烟纸消耗由3220 m/箱降低为3217 m/箱,滤棒消耗由8395支/箱降低为8382支/箱,商标纸消耗由2512张/箱降低为2507张/箱,提升了企业生产管理水平。     

浅谈药品生产GMP管理过程中质量风险管理的实施与应用

文章阐述了现行法规对质量风险管理的要求,描述如何有效实施风险管理,并描述风险管理在药品生产及监管过程中的要求,为制药企业在GMP管理过程中如何实施质量风险管理提供方向。     

安徽省食品药品监管督理局关于做好未通过新修订药品GMP认证无菌药品生产企业限期停产工作的通知

各市食品药品监督管理局，广德、宿松县食品药品监管局： 在各级食品药品监督管理部门和全省药品生产企业共同努力下，我省新版GMP实施工作推进顺利，已有27家企业93条生产线取得国家新版GMP证书或通过现场检查，有关工作进度快于全国平均水平。然而，全省还有个别企业或少数生产线没有通过国家认证。根据国家总局规定，现有药品生产企业血液制品、疫苗、注射剂等无菌药品的生产，应在2013年12月31日前达到《药品生产质量管理规范（2010年修订）》要求，逾期未通过新修订药品GMP认证的企业（车间）不得继续生产药品。现就无菌药品生产限期停产有关事宜通知如下：     

后GMP时代，制药企业的8道坎

在制药行业内，有一个约定俗成的时代划分，那就是以2004年7月1日为界，前一阶段称之为“前GMP时代”，后一阶段则称之为“后GMP时代”。因为从这一天起，通过了GMP认证的制药企业才有资格继续生产和销售药品，而没有通过的，则不得不停产整顿了。毋庸置疑，GMP认证使得药品的安全性和有效性得到了保障，药品质量得以改进；企业基础管理也明显得到改善，厂房、设施和设备等硬件装备水平显著提高；企业整体形象和品牌得到了一定提升，有效地支持了产品的市场推广和销售。但是，每一家制药企业或每一个生产车间都有必要参加认证吗？进行了认证就等于企业拥有了市场吗？通过了认证是不是就可以高枕无忧了呢？已经通过了认证的企业在接下来的经营管理中是不是像想象中那样顺利，它们又会遇到怎么样的难题？笔者认为，在后GMP时代，制药企业将面临8道坎：     

酱油生产企业在GMP审查时应注意的几个问题

GMP是我国的食品企业强制性技术规范，实施GMP管理制度，将会提高企业质量管理的自觉性和质量水平，推动我国食品工业质量管理体系向更高层发展。就酱油生产企业在GMP审查时应注意的几个问题进行了讨论，为企业通过GMP审查提供了参考意见。     

运用FMEA方法提高钢丝绳工序控制能力

以潜在失效模式及后果分析(FMEA)方法为例,介绍ISO/TS 16949:2002/QS 9000:1998配套管理工具的运用。结合电梯用钢丝绳绳芯直径过程控制,建立电梯用钢丝绳绳芯直径潜在失效模式及后果分析表。逐项说明过程、过程功能、潜在失效模式、潜在失效后果、严重度、级别、潜在失效起因、频度、现行过程控制、发现难度、风险序数、建议措施、责任和目标完成日期、措施后风险序数等栏目的内容。该方法的应用提高了生产过程的可靠性和钢丝绳的质量。     

Application of failure mode and effect analysis and cause and effect analysis on processing of ready to eat vegetables – part II

Failure mode and effect analysis (FMEA) model has been applied for the risk assessment of ready to eat vegetables manufacturing. A tentative approach of FMEA application to the ready to eat vegetables industry was attempted in conjunction with cause and effect diagrams. critical control points have been identified and implemented in the cause and effect diagram (also known as Ishikawa, tree diagram and fishbone diagram). The main emphasis was put on the quantification of risk assessment by determining the risk priority number (RPN) per identified processing hazard. Receiving, storage and distribution, packaging and cooling were the processes identified as the ones with the highest RPN (225, 225, 180 and 144 respectively) and corrective actions were undertaken. Following the application of corrective actions, a second calculation of RPN values was carried out leading to considerably lower values (below the upper acceptable limit of 130). It is noteworthy that the application of Ishikawa (cause and effect or tree diagram) led to converging results thus corroborating the validity of conclusions derived from risk assessment and FMEA. Therefore, the incorporation of FMEA and cause and effect analysis within the ISO22000 system of a ready to eat vegetables processing industry is considered imperative.     

基因改良食品的安全评价

从安全评价战略与法规、评价内容与范围、评价方法、国际市场上流通的商品以及售后监测等方面对基因改良食品的安全问题作了评述。     

An advisory tool to improve management practices affecting calf and heifer welfare on dairy farms

We developed an advisory tool addressing 10 critical areas of calf and heifer management, including calving management, care to newborn calves and painful procedures, colostrum management, cow-calf separation, calf feeding, weaning, calf housing, heifer feeding, heifer housing, and general monitoring. Targets and indicators for each critical area were validated by a panel of experts and maximum scores were assigned based on experts’ opinions and reviews of scientific literature. The tool was tested on 28 Quebec dairy farms for feasibility and repeatability between 2 observers. Farmers were asked to test colostrum quality, measure blood IgG concentrations, and record health events. The on-farm evaluation included an interview on management practices and an evaluation of conditions in the barn. Scorings and recommendations were discussed with producers. The usefulness of our on-farm welfare tool was evaluated by the producers themselves during a final debriefing. We reached the main goals of a successful advisory tool of calf and heifer management to improve welfare on dairy farms. We respected the targeted time limit of a 3-h visit covering all aspects of our tool including data collection on management and environment, scoring, practical demonstration with producers, and debriefing. We had no problems collecting management- and environment-based data and had high repeatability of qualitative environment-based measures (kappa value > 0.6). Our tool helped to detect problems and to discuss these problems with the producers; producers scored below 50% for some targets in calving management, care to newborn calves and painful procedures, colostrum management, and calf feeding. The targets were realistic so producers were not discouraged. All producers were convinced of the usefulness of our tool for identifying areas of calf and heifer management in need of improvement. They were also convinced of the usefulness of our tool as an advisory tool for technical advisors and veterinarians. Six months after the on-farm visit, recommended practices were implemented in many of these areas. Voluntary improvements in animal welfare can be facilitated by using appropriate tools to educate producers and help them change their attitudes toward calf management and animal welfare.     

Application of ISO 22000 and Failure Mode and Effect Analysis (FMEA) for industrial processing of salmon: a case study

The Failure Mode and Effect Analysis (FMEA) model was applied for risk assessment of salmon manufacturing. A tentative approach of FMEA application to the salmon industry was attempted in conjunction with ISO 22000. Preliminary Hazard Analysis was used to analyze and predict the occurring failure modes in a food chain system (salmon processing plant), based on the functions, characteristics, and/or interactions of the ingredients or the processes, upon which the system depends. Critical Control points were identified and implemented in the cause and effect diagram (also known as Ishikawa, tree diagram and fishbone diagram). In this work, a comparison of ISO 22000 analysis with HACCP is carried out over salmon processing and packaging. However, the main emphasis was put on the quantification of risk assessment by determining the RPN per identified processing hazard. Fish receiving, casing/marking, blood removal, evisceration, filet-making cooling/freezing, and distribution were the processes identified as the ones with the highest RPN (252, 240, 210, 210, 210, 210, 200 respectively) and corrective actions were undertaken. After the application of corrective actions, a second calculation of RPN values was carried out resulting in substantially lower values (below the upper acceptable limit of 130). It is noteworthy that the application of Ishikawa (Cause and Effect or Tree diagram) led to converging results thus corroborating the validity of conclusions derived from risk assessment and FMEA. Therefore, the incorporation of FMEA analysis within the ISO 22000 system of a salmon processing industry is anticipated to prove advantageous to industrialists, state food inspectors, and consumers.     

Application of ISO22000, failure mode, and effect analysis (FMEA) cause and effect diagrams and pareto in conjunction with HACCP and risk assessment for processing of pastry products

The Failure Mode and Effect Analysis (FMEA) model has been applied for the risk assessment of pastry processing. A tentative approach of FMEA application to the pastry industry was attempted in conjunction with ISO22000. Preliminary Hazard Analysis was used to analyze and predict the occurring failure modes in a food chain system (pastry processing plant), based on the functions, characteristics, and/or interactions of the ingredients or the processes, upon which the system depends. Critical Control points have been identified and implemented in the cause and effect diagram (also known as Ishikawa, tree diagram, and fishbone diagram). In this work a comparison of ISO22000 analysis with HACCP is carried out over pastry processing and packaging. However, the main emphasis was put on the quantification of risk assessment by determining the Risk Priority Number (RPN) per identified processing hazard. Storage of raw materials and storage of final products at -18°C followed by freezing were the processes identified as the ones with the highest RPN (225, 225, and 144 respectively) and corrective actions were undertaken. Following the application of corrective actions, a second calculation of RPN values was carried out leading to considerably lower values (below the upper acceptable limit of 130). It is noteworthy that the application of Ishikawa (Cause and Effect or Tree diagram) led to converging results thus corroborating the validity of conclusions derived from risk assessment and FMEA. Therefore, the incorporation of FMEA analysis within the ISO22000 system of a pastry processing industry is considered imperative.     

Purification and Use of Glycomacropeptide for Nutritional Management of Phenylketonuria

ABSTRACT:  Individuals with phenylketonuria (PKU) cannot metabolize phenylalanine (Phe) and must adhere to a low-Phe diet in which most dietary protein is provided by a Phe-free amino acid formula. Glycomacropeptide (GMP) is the only naturally occurring protein that does not contain Phe, and is of interest as a source of protein for dietary management of PKU. However, commercially available GMP contains too much Phe from residual whey proteins and does not contain adequate levels of all the indispensable amino acids to provide a nutritionally complete protein. The aim of this study was to increase purity of GMP and develop a mass balance calculation for indispensable amino acid supplementation of GMP foods. Cation exchange chromatography, ultrafiltration/diafiltration, and lyophilization were used at the pilot plant scale to decrease Phe. Enough purified GMP (5 kg) was manufactured to provide 15 PKU subjects with a 4-d diet in which the majority of protein was from GMP foods. A mass balance was used to supplement GMP foods so that all indispensable amino acids met or exceeded the daily recommended intake. GMP foods were tested in a human clinical trial as a replacement for the traditional amino acid formula. Nutritionally complete GMP foods created with high purity GMP provide individuals with PKU with more options to manage PKU, which may lead to improved compliance and quality of life.     

Application of failure mode and effect analysis model to foodservice systems operated by chefs in practice and by chefs from a culinary school in Turkey

Failure mode and effect analysis (FMEA) methodology has been applied for the risk assessment of basic foodservice systems operated by the “chefs in practice” and by the “chefs from a culinary school” in Turkey. Firstly, the preliminary hazard analysis was done to predict the potential failure modes in the food flow of basic foodservice systems. Each step in the process, from receiving of raw ingredient to table, was analyzed. The risk priority numbers (RPN) were calculated for each failure mode. The corrective actions were suggested to lower the RPN values below the acceptable limit of 120. The data collected in this study compared to the data from a study carried out with “chefs in practice” about basic food safety issues. The significant difference was observed between “the chefs in practice” and “the chefs with formal culinary education”. Majority of chefs from a culinary school have scored better in many food safety issues, so thus the corrective actions in the FMEA table. The results clearly point out the urgent need for FMEA integration and for food handler education in current foodservice establishments in Turkey.