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Errors in pharmaceutical analysis ppt 

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Particle size, particle orientation, and data collection  Error Analysis. “FDA encourages the use of new technologies and PAT techniques, such as NIR spectroscopy, for content uniformity analysis,” says Robertson. PowerPoint Presentation: The Kefauver-Harris Amendments to the FD&C Act were approved in1962 with Section 501(a)(2)(B) as an amendment. 4 Costs of Medication Errors For example, working overtime with inadequate resources, poor support, and low job security all contributed to an increased risk of medication errors by nurses. Cause Analysis – Systematic Approach Root cause investigation should be a structured approach designed to provide reliable results that can be acted upon. It is the power to detect the change. consideration of the margin of analytical error”. 5 Mar 2017 Analytical Chemistry & Role in pharmaceutical industry Different techniques of analysis Significant Figures Errors - Types & Minimization  20 Mar 2018 Chapter: Pharmaceutical Drug Analysis: Errors In Pharmaceutical Analysis . Unfortunately, errors and especially errors propagated when people are present can be quite catastrophic. Bureau of Economic Analysis, National Income and Product Accounts. they account for more than 80 percent of process deviations in pharmaceutical manufacturing. Atomic Absorption Spectroscopy. 1 Titrimetric techniques Origin of the titrimetric method of analysis goes back to somewhere in the middle of the 18th century. Scope of Medication Errors • Each year in the U. 8 million inpatient admis-sions and 3. Examples of errors in chemical analysis include: D. The value of power is equal to 1-. PwC believes that seven major trends are I belongs to pharmaceutical industry. The requirements to be met by pharmaceutical packaging and pack-aging materials as described in compendia (pharmacopoeias) and standards (e. Module 14. before the application for the marketing authorization is submitted. Pharmaceutical analysis contract services can play an important role in your the development process and GMP manufacturing. A correctly performed root cause analysis has depth and breadth--concepts that will be explained. 2nd Edition, Eds. Types of errors in Pharmaceutical analysis There are two types of errors in Pharmaceutical analysis which are as follows Errors Determinant Indeterminant  Measurements invariably involve errors and uncertainties. org/site_media/media/medialibrary/2014/08/Module_14_GCLP_CORRECTIVE_ACTION_PREVENTIVE_ACTION. J. Almost half of the fatal medication errors occurred in people over the age of 60. The pharmaceutical analysis is a branch of chemistry, which involves the series of process for the identification, determination, quantitation, and purification. nsf. Signal recording 6. pharmaceutical nomenclature (e. S. Pat West. on errors in pharmaceutical analysis and their statistical validation. Therefore, the  risk analysis in pharmaceutical products), suggests their use also in the area of ment must aim to minimize the risk of errors and permit effective cleaning and . fcfar. R. identity and strength with respect to the active pharmaceutical ingredient (API) and the presence and levels of impurities. Assessment of mass balance  4 May 2018 Even the best random samples will always be a little different from the true population of interest. The result of The Kefauver–Harris drug amendments, Provided an additional powerful regulatory tool to FDA to stop particular manufacturing process when the drug product is deemed to adulteration. Error Analysis and Significant Figures. 30 Dec 2016 sorces of impurities, Thesis for Pharmaceutical Chemistry . Most of the root causes of deviations are human errors due to improper communication or failure to follow the written procedure. A generic chemical reaction for titrimetric analysis is Pharmaceutical Dosage Forms: Tablets. Research has revealed that distractions contribute to medication errors. know the analysis of the inorganic pharmaceuticals their applications; and 1 Errors. WHO Technical Report Series, No. 340-342. 5 billion in lost productivity, wages, and additional medical expenses. 1. This tool evaluates system (or sub-system) failures one at a time but can combine multiple causes of failure by identifying causal chains. Friedman, Associate Director, Source of errors •Processes may be referred to as having sharp and blunt ends. Open in figure viewerPowerPoint. This phase may include specimen handling issues that occur even prior to the time the specimen is received in the laboratory. , serious preventable medication errors occur in 3. To protect consumer safety and to deliver high quality products the Pharmaceutical industry needs to analyse and control risk of human error, as any other risk. Dec 26, 2013 · An understanding of analytical errors is essential before you report your results with the required level of confidence. Swot Analysis Essay 2452 Words Jul 2, 2012 10 Pages Walgreens Company SWOT Analysis Melanie Garces MGT/521 July 16, 2012 Kirk Davis Abstract This paper will provide insight into the strengths, weaknesses, opportunities, and threats of the Walgreens Company, the nation’s leading drugstore chain. Writing a Literature Review General Guidelines to Writing a Literature Review Introduce the literature review by pointing out the major research topic that will be discussed Identify the broad problem area but don’t be too global (for example, discussing the history of education when the topic is on specific instructional strategy) Discuss the general importance of your topic for those in In the next step it is important to remember that, unless the balance is checked before each weighing operation is performed, errors can easily occur, resulting in faulty analytical data. analysis estimates the amount of certain element or compound in the substance i. Pharmaceutical Analysis Contract Services. Abstract Presented at the Patient Safety Congress. Medical practice generally does not change based upon the results of one study. This difference is referred to as sampling error. effects analysis refers to studying the consequences of those Overview: Root cause analysis is a structured team process that assists in identifying underlying factors or causes of an adverse event or near-miss. • It removes the safety issues surrounding blend sampling of toxic or potent drugs manufactured in isolated environments. Jan 11, 2017 · over view of pharmaceutical analysis 1. These tips tell what you can do to get safer care. 3. Recent applications of analytical techniques for quantitative pharmaceutical analysis: a review RUDY BONFILIO Departamento de Fármacos e Medicamentos, Faculdade de Ciências Farmacêuticas Univ Estadual Paulista (UNESP) Rodovia Araraquara-Jaú, km 1, CEP 14801902. results. 1 Dispensing errors account for ~21% of all medication errors. The ISA S95 standard defines a model for manufacturing operations, including the reporting and analysis functions that are critical to effective manufacturing. Oct 28, 2014 · Pharmaceutical products have to be of high quality with respect to a number of predefined attributes, e. e. Fortunately, there are multiple downstream opportunities for these errors to be intercepted by the pharmacist, pharmacy information system, or nurse, for example. In the case of the hazard analysis, failures, operating procedures, human factors, and transient conditions are included in Successful Microbiological Investigations 14~w /~t'M ~~~ RMM in the pharmaceutical, medical device and biotechnology detailed a variety of errors (errors sterile pharmaceutical productssterile pharmaceutical products yIt is recognized that there is no current regulatory requirement for microbial control in the manufacture of non-sterile pharmaceutical productspharmaceutical products Overview (continuation) yGuidance and Recommendations for Gap Analysis In terms the current method, it should be fully reviewed to ensure that it is identical to the registered test method, and that any claims made in the method are supported by the method validation. Errors in Pharmaceutical Analysis. Systems analysis of adverse drug events. Jürgen Mählitz GMP Inspector District Government of Swabia Fronhof 10 D-86152 Augsburg Germany APV Training Course GMP Requirements June,10th to11th 2004 Istanbul, Turkey Get a professional root cause analysis template to analyze the problems and to plan a reasonable solution. The first aspect is either in percent (%) or in parts per thousand (ppt). With the understanding that humans are imperfect and will make errors, attention was directed to systems that would support health professionals in care delivery and could help identify errors before they affected patients. Free medical PowerPoint templates are available at no cost but lack the polish of premium offerings. A comparative study of prescribing errors in three NHS organisations. Received 19 January 2011 Accepted 10 Jul 27, 2006 · Release last week of the Institute of Medicine (IOM) report, Preventing Medication Errors, has led to considerable excitement and media coverage, even outside the US. tghn. Santhi and K. pp. Significance of quantitative analysis in quality control, Different techniques of analysis, Preliminaries and definitions, Significant figures, Rules for retaining significant digits, Types of errors, Mean deviation, Standard deviation, Statistical treatment of small data sets, Selection of sample, Precision and accuracy. Kids are especially at high risk for medication errors because they typically need different drug doses than adults. The balance user should check the Balance Environment, Calibration, and Balance Uncertainties. 3 Acid-base titrations. Q:Deviations in clinical trials happen, and as such, FDA requires deviations to be investigated and documented. The doctors and the other support staff not just have a requirement of coming up with better techniques of treatment but also at the same time they also have the requirement of telling others the best ways, which are more effective. 25e26 May 2010. 5Fault Tree Analysis (FTA) is a top-down analysis which starts with top undesirable conditions which should be conceivable early in the design phase. Jun 13, 2018 · Giving the wrong drug and using the wrong route of administration each accounted for 16% of the errors. The objective of this study is to explore the understanding of Process Failure Mode and Effective Analysis in Pharmaceutical Manufacturing. Birmingham. Certification 10. But it is very difficult to obtain an almost pure substance. Providing advice and clarifications about drugs to other health professionals and patients is highlighted several times in the report. Human errors are traced by the occurrence of the deviations in the process. If you do have good estimates for the measurement errors then a A failure modes and effects analysis (FMeA) examines potential failure modes within a system for classification by severity or determination of the effect of failures on the system. In practice, there is no absolutely correct measurement, this is due to methods used and instruments imperfection. Karthikeyan* 1Department of mathematics, SAS, VIT University, Vellore-14, T. The series is published monthly, 12 issues per year, for $4,995. g. Pharmaceutical Analysis 2. 100(a)(1) • How does your firm categorize and group data and perform the analysis? – Expect FDA to verify your firm is using appropriate analysis techniques – Analysis of data should also include a comparison of the same problem type across different data sources Pre-analytical, Analytical, and Post-analytical Phases of Testing The pre-analytic testing phase occurs first in the laboratory process. Since 1989, a number of major pharmaceutical companies (Merck, Novartis, Pfizer, etc. com. 8 Hyphenated techniques 1. 10 steps of chemical analysis 1. Each of the medical PPT themes featured here has hundreds of professional presentation options that are specifically designed for medical presentations. Example: forecasting sales at Kroger Kroger sells (among other stuff) bottled spring water ? Jul 1,195 Jun 1,210 May 1,275 Apr 1,305 Mar 1,353 Feb 1,325 Jan Bottles Month What will the sales be for July? please see Good manufacturing practices for pharmaceutical products: main principles. 7% and 24% of prescriptions are dispensed erroneously, and that 1. Pharmaceutical analysis Pharmaceutical Analysis may be defined as the application of analytical procedures used to determine the purity, safety and quality of drugs and chemicals This course has access to the full range of Titration method Spectroscopic technique Chromatographic method Spectrophotometry etc. 1 May 2017 introduction, classification of errors, accuracy , precision, minimizing systemic errors. “Unwarranted variation is endemic in health care. • Residual stress analysis methods • High resolution XRD methods Rocking curve analysis Reciprocal lattice mapping • X-ray reflectivity methods • X-ray fluorescence methods • X-ray analysis summary • Comparison with other techniques • Quick guide to the FS-MRL x-ray analysis facilities • Recommended literature. April 2002. Emphasis is placed on the application and practical, hands-on aspects of how to facilitate root cause analysis. requirements for the prospective analysis and redesign of systems identified as having the potential to contribute to the occurrence of a sentinel event (FMEA) • JCAHO expects healthcare facilities to set FMEA priorities based on their own risk management experiences or external sources Medication errors are a leading cause of mortality in the United States. Sample preparation 4. Download Guide for Authors in PDF Aims and scope Journal of Pharmaceutical Analysis (JPA) is a peer-reviewed open access journal for original research articles, review articles and short communications related to all aspects of pharmaceutical analysis. Design flaws, methodological errors, problems with study conduct, or analysis and reporting mistakes can render a clinical trial suspect. Older people may be at greatest risk for medication errors because they often take multiple prescription medications. Although most of the recommendations in the document have been previously suggested, ISMP views the report as an excellent reinforcement of error-reduction concepts that have been stressed by the medication safety community Examples of critical and major observations from GMP inspections of Manufacturing, QC and Contract Research Organisations Prequalification Programme: Priority Essential Medicines Essential Medicines Policies, WHO, Geneva. 4% of medication errors and 59% of them were due to Hundreds of thousands of patients aged over 65 years in England were prescribed an NSAID without a gastroprotective medicine over a three-month period in 2017, according to new data published by NHS Business Services Authority intended to improve patient safety. This section will address accuracy  Both errors in the act of writing (prescription errors) and prescribing faults due to erroneous . General Principles In titrimetric analysis volumetrically measures the amount of reagent, often called a titrant, required to complete a chemical reaction with the analyte. Analysis Group, Inc. Must establish the reliability of the data (i. The Pharmaceutical industry's long successful strategy of placing big bets on a few molecules, promoting them heavily and turning them into blockbusters worked well for many years, but its R&D productivity has now plummeted and the environment’s changing. These PowerPoint presentations are shared by people all over the world to help you. Statistical Methods prescribing errors in hospital inpatients. F. Phil (Management) Senior Chemist, Albert David Limited. This Guide outlines the current thinking of methodology, based on the methods prescribed in the ISO Technical Advisory Group on Metrology (TAG4’s) lengthy document ISO guide 98 on "Guide to the Expression of Uncertainty in May 16, 2003 · Root cause analysis with corrective action addresses the question "Why is the product nonconforming in the first place and how do we avoid having more of it in the future?" This may take considerable investigation and an investment of time. Medication errors and organisational culture in the Pharmacy 97 Professor Nick Barber 10. Mistakes in calculating the errors also come under this category. Pharmaceutical Care (CD-P-PH) (steering body) co-ordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, commissioned a survey on key concepts in pharmaceutical care and the performance indicators used to evaluate the quality of pharmaceutical care and pharmaceutical Most errors result from problems created by today's complex health care system. Methods A controlled before and after study with baseline and follow-up measurements was conducted in an intensive care unit (ICU) and a post-surgical HPLC for the analysis of thermally labile, nonvolatile, highly polar compounds. Analysis 5. What You Can Do To Stay Safe. London. com July 2017 The author gratefully acknowledges support from the Pharmaceutical Research and Manufacturers of America. There may be images in this book that feature models; these models do not necessarily endorse, represent, or participate in theactivities management and analysis aspects of clinical research • Minimize errors in datasets • Ensure statistical software packages will recognize data correctly • Facilitate efficient data analysis for projects & Drug Letter (ISSN 0362-6466), is an in-depth analysis of regulations and issues affecting the pharmaceutical and biologics industries. Analysis of standard samples: The errors of method can be checked by carrying out the analysis of standard sample prepared in such a way that its composition is exactly the same as that of material to be analyzed. The following proposal presents strategies for in-process dosage unit analysis and blend sample This diagram is a representation of where MES would reside in a typical pharmaceutical facility in accordance with the ISA S95 standard (2). org/info/pharma-training for more information on the next available course. 25,26 Errors are more likely to occur when tasks are carried out after hours by busy, distracted staff, often in relation to Example Identifying a gene that is associated with smoking may help: Target prevention programs toward at-risk adolescents Assist in understanding the biological basis of addiction to nicotine Lead to the development of pharmaceutical treatments for smokers who wish to quit Delimitations – scope of study Description of subjects Description of Jul 20, 2006 · Surprisingly, smaller pharmaceutical firms often take a more systematic approach to handling CAPA complaints than larger companies. pharmaceutical products. 8-10 In a study by Esqué Ruiz et al. Most research has focused on dispensing errors, and investigators estimate that between 1. Increase awareness of medication errors and methods of prevention throughout the health care system. Quantitative Analysis in HPLC A quantitative analysis involves many steps that are briefly summarised as follows: vThe failure rate for Errors 1734 and 1736 for all application types received in CY2018 is 21. state the correct use of various equipments in Pharmaceutics laboratory relevant to . These data are available starting in 1999. Errors using inadequate data are much less than those using no data at all --- C. The purpose of FMEA is to analyze design characteristics relative to the planned manufacturing process to ensure that the resultant product meets customer’s needs and expectations. The best way you can help to prevent errors is to be an active member of your health care team. shall not be liable for errors contained herein or for incidental consequential damages in Analysis of Pharmaceutical Nov 29, 2016 · The proper RCA (root cause analysis) tool should be chosen for the problem at hand. Signal processing 7. 4. ) Batch number A distinctive combination of numbers and/or letters which uniquely identifies a batch on the labels, its batch records and corresponding certificates of analysis, etc. It is not yet used in the routine analysis of food, however. Sampling (sampling errors!) 2. Ermer and P. Overlaid To decrease relaxation error, waiting approximately 8× T1 results in approximately 99. Vamshi, Krishna T and Kumar, Lalit and Reddy, Sreenivasa M and Muddukrishna, BS and Pai, Girish K (2014) Process deviations in pharmaceutical industry: various types, handling procedure and systems. pharmaceutical industry over the past two decades. Today… Mortality from major disease is down dramatically – due in part to pharmaceutical interventions Source on US consumer expenditures: U. Investigators estimate that between 11% and 38% of ADEs in the to chemical analysis and microbiological analysis and its effects on compliance. Filing systems analysis, process improvement, and care improvement. Personal errors - occur where measurements require judgment, result from prejudice, color acuity problems. ISSN 0974-3618 Deviation and Out of Specification Handling Dr. 97% relaxation. Analytical chemistry studies and uses instruments and methods used to separate, identify, and quantify matter. Pharm (Pharmaceutics), Mba (Hrm), M. The formulation of a pharmaceutical product should be studied in detail and qualified at the development stage, i. Overview. Relative error (Er) – expressed as % or in ppt. Of course, new errors may also arise during these intermediate steps. 71ipcchennai. Nahata College of . 2 Volumetric analysis. Can be minimized or eliminated with proper training and experience. PDA/FDA Executive Management Workshop. 9. Originally CE was applied primarily in the analysis of biological macromolecules, but fMRI Analysis Overview Higher Level GLM First Level GLM Analysis First Level GLM Analysis Subject 3 First Level GLM Analysis Subject 4 First Level GLM Analysis Subject 1 Subject 2 X C X C X C X C Preprocessing MC, STC, B0 Smoothing Normalization Preprocessing MC, STC, B0 Smoothing Normalization Preprocessing MC, STC, B0 Smoothing Normalization human factors analysis and classification system (HFACS) has recently been developed to meet those needs. com). Sharp end –the person actually doing the task Blunt end – the influences on the process farther away from the action itself. N, India. The data on US firms’ foreign pharmaceutical R&D spending come from the National Science Foundation. However, in most cases, analysis of error-inducing conditions shows an  1. One of the basic gross errors that occurs frequently is the improper use of an instrument. Sample naming 3. Allison O. Pharmaceutical Calculations is an independent publication and has not been authorized, sponsored, or otherwise appro ved by the owners of the trademarks or service marks referenced in this product. . Not getting to the true root cause. International Journal of Generic Drugs. CY2018’s average of 78. 4 Basic Lessons in Laboratory Quality Control Foreword Achieving quality in the medical laboratory requires the use of many tools. Failure modes are any errors or defects in a process, design or equipment — potential or actual. In addition to an analysis of how and why errors occur, this workshop features Errors may occur also due to incorrect adjustment of instruments and computational mistakes. Abstract :The inventory management system plays a vital role in a pharmaceutical industry. LPH-432-0517 ABOUT THE AUTHOR Martin Lush has over 30 years’ experience in the pharmaceutical and healthcare industry. Manufacturing and Process Engineers envision a process is free of errors. ) have chosen to locate new laboratories in one or more major life science hotspots (Massachusetts, the San Francisco Bay Area, and San Diego County). ASHUTOSH KAR Errors C. Bulk product NMR SPECTROSCOPY: NMR SPECTROSCOPY NMR is a spectroscopy technique which is based on the absorption of Electromagnetic radiations in a radio frequency region 4 to 900 MHz by nuclei of atoms in the presence of magnetic field. A hazard analysis uses a top -down methodolo gy that first identifies risks and then isolates all possible (or probable) causes. Most of what is known relates to additional health care costs associated with preventable ADEs, which represent the injuries caused by errors. Human factor research in nonmedical settings suggests that demanding greater vigilance from providers of medical care may not result in meaningful safety improvement. Definitions of Abuse, Misuse, Off-label Use and Medication Error . Use Bow Tie Tool for Easy Hazard Identification Presented at 14 th Asia Pacific Confederation of Chemical Engineering Congress Singapore, 21-24 February 2012 Syed Zaiful Hamzah • Weighing errors during blend sample analysis are eliminated. At the same time its usage has grown enormously, expanding from a relatively small set of specific application areas (such as design of experiments and computation of life insurance premiums) to almost every walk of life. 14 Apr 2011 Department of Pharmaceutical Analysis, B. 1 A number of types of medication errors, such as prescribing errors or medication administration Pharmaceutical Licensing Deals Pharmaceutical licensing deals rarely, if ever, involve a simple one time payment, but encompass multiple payments and royalities, and require long-term cooperation. Do you have PowerPoint slides to share? If so, share your PPT presentation slides online with PowerShow. 3 Propagation of Errors Significant figure rules are sufficient when you don't have god estimates for the measurement errors. This is very important because several decisions of compliance or non-compliance are based on analytical results in pharmaceutical industries. Analytical chemistry studies and uses instruments and methods used to separate, identify, and Analytical chemistry plays an increasingly important role in the pharmaceutical industry where, aside from QA, it is . The limits and reliability must be determined by statistically valid methods. Fault Tree Analysis JAnuAry/FebruAry 2012 PHARMACEUTICAL ENGINEERING Online Exclusive 3 ment determine the scope of compliance documentation, e. This workshop explains how small improvements in manufacturing systems and employee training can deliver big results. At least for smaller compounds, such quality control often involves chromatographic methods. Bioassays are quantitative biological assays used to estimate the potency of agents by observing their effects on living animals (in vivo) or tissue/cell culture systems (in vitro). 2,3 • The Institute of Medicine, in its report To Err Is Human, estimated 7,000 deaths in the U. Specialist pharmaceutical analysis contract services to support development programs (R&D), regulatory submissions, GMP manufacturing and post-marketing requirements. Baltimore, MD (September 12-13, 2012) Richard L. unesp. Making IV therapy safer: competence training, safety culture and 107 technology Dr Martin Pickstone & Mr Chris Quinn 11. Process Failure Mode and Effects Analysis (PFMEA) looks at each process step to identify risks and possible errors from many different sources. May 02, 2018 · Despite considerable effort, medication errors continue to occur and result in patient harm. Do not assume that the balance has been left in the proper Source and effect of Impurities in Pharmaceuticals We know that the substance that are used in pharmaceutical field must be pure so that they can be used safely. ➢ We can   no analysis is free of error or “uncertainty” Instrument errors - failure to calibrate , degradation of parts in the . 'product issue'); . 6 Electrophoretic methods 1. long@analysisgroup. Distinguish between process problem or measurement error using JMP® to Analytical methods are crucial in supporting pharmaceutical development and . Analytical errors is essential before submit your report and results with Related Conference of Errors in Pharmaceutical Analysis. Rapid increase in pharmaceutical How dispensing errors can be reduced is described in the Panel (right). In error the true value and observed value in chemical analysis can be related with each other by the equation. 0% vs. Related components are the impurities in pharmaceuticals which are unwanted . The textbook on ‘Pharmaceutical Drug Analysis’ would enormously serve the undergradu-ates, postgraduates, researchers, analytical chemists working in the Quality Assurance Laborato-ries, new drug development, production and control, teaching, or regulatory authorities. May 03, 2016 · Rather, they say, most errors represent systemic problems, including poorly coordinated care, fragmented insurance networks, the absence or underuse of safety nets, and other protocols, in addition to unwarranted variation in physician practice patterns that lack accountability. Summarizing reports of medication mistakes submitted to the Institute for Safe Medication Practices for analysis, this news article describes types of problems, prevention strategies, and technologies that can reduce risks. Since the early 1980s, the People’s Medical Society has developed guidelines to help consumers avoid medication errors in hospitals and at community and mail-order pharmacies (Personal communication, Charles Inlander, March 25, 2005). – A free PowerPoint PPT presentation (displayed as a Flash slide show) on PowerShow. Abstract Presented at Royal Pharmaceutical Society Conference. Gupta Lane, Kolkata-700 050, India The medical world faces some of the most obstinate challenges in terms of new viruses and diseases that throng the world. 5. OOS results are most often generated due to laboratory or manufacturing-related errors, the setting of inappropriate specifications, or poor method development. easy to follow), unambiguous and free from any errors. com - id: ab0c7-YjAzZ Apr 15, 2006 · The textbook Pharmaceutical Analysis: A Textbook for Pharmacy Students and Pharmaceutical Chemists (2nd edition) helps students meet this challenge by striking a fine balance between theory and application. , establish limits within which the true value lies with a known probability). 4%) vFDA has identified the need to provide additional clarifications on TRCto help or pharmaceutical manufacturers. Franklin BD, Reynolds M. Examine and evaluate the causes of medication errors. Current Expectations for Pharmaceutical Quality Systems . in Pharmaceutical Manufacturing Pharmaceutical Manufacturing Independent & isolated functions, divisions and geographical units Complex processes, many non-value added activities Focus on end product, not on process -> high rework rates Processes to be validated Need to focus on reducing waste and variability ©2011 Waters Corporation 3 Sep 29, 2012 · The data on foreign firms’ US pharmaceutical R&D spending and assets come from the Bureau of Economic Analysis, assets by industry and country. As far as my knowledge the Computer System Validation is very useful to validate a accuracy, reliability, consistent intended performance, and ability of any technology component (Software or Hardware). Value is created as the potential new drug becomes more likely to reach the market and revenue becomes a less distant hope. Our company has an established deviation investigation process. 6% vOverall conformance for Errors 1734 and 1736 improved compared to the previous analysis (previous years’ average of 68. Finding the true root cause is critically important. those of the International Organization for Standard- Method Validation in Pharmaceutical Analysis. Because these are de novo green-field labs, we have an unusual Examples of systematic errors caused by the wrong use of instruments are: errors in measurements of temperature due to poor thermal contact between the thermometer and the substance whose temperature is to be found, errors in measurements of solar radiation because trees or buildings shade the radiometer. 2. Photocopying or reproducing in any form, includ- Related Journals for Statistical Methods Statistical Methods in Medical Research, Journal of Modern Applied Statistical Methods, Statistical Methods and Applications, Biocatalysis and Agricultural Biotechnology, Neurocomputing, Biological Conservation, Journal of Pharmaceutical and Biomedical Analysis, Clinical Biochemistry. 5% to 4% of these errors could cause harm. Before process validation can be started, manufacturing equipment and control instruments, as well as the formulation, must be qualified. rudybonfilio@yahoo. ➢ it is impossible to perform a chemical analysis that is totally free of errors or uncertainties. Download templates for Word, Excel, PPT and PDF. The static error of a measuring instrument is the numerical difference between the true value of a quantity and its value as obtained by measurement. Systematic Errors – These errors are due to shortcomings of the instrument, such as defective or worn parts, ageing, or effects of the environment on the Reading: Analysis of Errors Revised 2/9/13 1 ANALYSIS OF ERRORS Precision and Accuracy Two terms are commonly associated with any discussion of error: "precision" and "accuracy". Methods of recognizing errors. The results are represented pictorially in the form of a tree of fault modes. Capillary electrophoresis (CE) is a relatively new but rap-idly growing separation technique. Kindly complete the registration process as soon as possible(www. necessary for the cause analysis;. During drug preparation, nurses can be distracted when they're interrupted. The method should be clear (i. Problems Facing the Pharmaceutical Industry and Approaches to Ensure Long Term Viability Abstract This paper examines the Pharmaceutical (Pharma) industry and the changes that have occurred particularly over the last 10 years as a result of the overall economic downturn, the rising cost of healthcare and the costs The United States Pharmacopeiadefines medication errors as any preventable event that may cause or lead to an inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. each year are due to preventable medication errors. The curriculum focuses on the efficient and practical use of statistics in the pharmaceutical industry. Pharmaceutical Technology. A very brief version was presented in the above content. due to similarities in drug brand names or pharmaceutical names [ 13]. Jul 21, 2016 · This 100% online course explores basic statistics and pharmaceutical applications in the industry. To better understand which errors may lead to serious adverse outcomes, the risk needs to be assessed and appropriately addressed. 7 Flow injection and sequential injection analysis 1. Congratulations to the participants whose abstract has been accepted for e-poster presentation on the 71st Indian Pharmaceutical Congress 2019, Chennai. br “Human Error: Causes and Prevention” visit www. • It accounts for potential segregation after blending. Objective:To lay down a procedure for handling of Out of trend for stability sample; Scope:This procedure shall be applicable for handling of out of trend of stability sample at quality control of pharmaceutical company name with location. Labeling errors and wrong-drug errors occur frequently. Systematic (determinate) errors 14 Detection of Systematic Errors 1. br www. W hen proton (hydrogen) is studied then it is called as proton magnetic resonance. The textbook begins with a chapter on the quality control of analytical methods and the correct reporting of data. Ligi Mathews, Christina Chandler, Satish Dipali, Prasad Adusumilli, Stanley Lech, Nancy Mathis et al. XPowerPoint PPT search engine is especially designed for Doctors and Teachers to help find accurate PowerPoint presentations for their research. 10 The number of opportunities for errors per patient in the medical ward was 44 (range 22–59) and in the surgical ward 29 (range 15–46). The Fault Tree Analysis tool is an approach that assumes failure of the functionality of a product or process. Gross Errors. Pharmaceutical analysis [1-3] plays a very outstanding role in the examination of pharmaceutical formulations and bulk drugs regarding the quality control and assurance. Oct 01, 2014 · Frequency of medication errors in an emergency department of a large teaching hospital in southern Iran Afsaneh Vazin,1 Zahra Zamani,1 Nahid Hatam2 1Department of Clinical Pharmacy, Faculty of Pharmacy, 2School of Management and Medical Information Sciences, Shiraz University of Medical Sciences, Shiraz, Iran Abstract: This study was conducted with the purpose of determining the frequency of Jul 02, 2012 · Walgreens Co. Pharmacists’ roles in preventing errors in the medication process are much wider than just dispensing. - 4 - 2. There were no statistically significant differences between the wards. Data for 2002 is the latest available. However, before talking about errors you should have clarity on the terms accuracy and precision. In Pharmaceutical Industry risk level of the analysis. CAPA Data Analysis – 21 CFR 820. Specifically, the HFACS framework has been used within the military, commercial, and general aviation sectors to systematically examine underlying human causal factors and to improve aviation accident investigations. It was the year 1835 when Gay–Lussac invented the volumetric method which A 'read' is counted each time someone views a publication summary (such as the title, abstract, and list of authors), clicks on a figure, or views or downloads the full-text. 5 Kinetic method of analysis 1. 5 million Americans each year and cost $3. Quantification uses peak areas or heights to determine the concentration of a compound in the sample. The primary objective of this course is to recognize the value of conducting proper root cause analysis and documenting failure investigations. Untidy working areas also increase the risks of medical errors especially when working in busy environment (Aspden, 2006). Methods used in pharmaceutical analysis must be sufficiently accurate, specific, sensitive and precise to conform to the regulatory requirements as set out in the relevant guidelines of "The International Conference of Technical Requirements for the Registration of Pharmaceutical for Human Use " (ICH), which are applied by Introduction to medication errors and medication safety Molly Courtenay and Matt Griffiths A medication safety incident is defined by the National Patient Safety Agency (NPSA) as: ‘any unintended or unexpected incident which could have or did lead to harm for one or more patients’ (NPSA, 2007:9). 8 Mar 2018 Application of 19F quantitative NMR to pharmaceutical analysis. Title: Good Documentation Practices (GDPs) in Pharmaceutical Industry Author: Krishan Kumar Subject: Krishan Kumar, Laboratory for Translational Research in Imaging Pharmaceuticals, Wright Center of Innovation in Biomedical imaging, Department of Radiology, The Ohio State University, Columbus, OH 43212, USA Aug 19, 2017 · Medication errors can happen to anyone in any place, including your own home and at the doctor's office, hospital, pharmacy and senior living facility. measurement and scientific analysis into the world of exploration, comprehension and decision-making. Mar 12, 2008 · Medication errors in critical care are frequent, serious, and predictable. , validation documentation. . Volumetric (Titrimetric) Analysis. Analysis of prescription : Give two prescriptions and ask student to report error precision, errors and their types, significant figures, standard deviation,. We will concern ourselves with: 1. Jul 18, 2016 · At present, there is limited evidence available regarding medication administration errors that occur in the community setting. Misplacing or omitting decimals can result in serious calculation errors. Frequency of medication errors varied between the different stages in the medication process. But errors also happen when doctors* and patients have problems communicating. Plausibility check 9. This category of errors includes all the human mistakes while reading, recording and the readings. Presented by Ian Thrussell Head of Inspections thrusselli@who. b. Araraquara-SP BRAZIL. May 01, 2017 · The determinate personal errors may be eliminated by care, practice and self discipline 32. If the method is in a BUSINESS & PROCESS TRANSFORMATION Business Transformation, whether driven by M&A activity, new corporate strategy or the need to affect the bottom line, requires the alignment of People, Process and Technology with business strategy and vision. Ft+1 is the forecast for next period n is the forecasting horizon (how far back we look), A is the actual sales figure from each period. 13 Jul 2018 Human Error and its Impact on the Pharmaceutical Industry specialists, an in depth root-cause analysis of each investigation can take place. Research Journal of Pharmacy and Technology, 7 (3). A simple root cause analysis tool called “5 Whys” is a quick, easy way to identify the underlying conditions leading to a deviation. While feature-rich, they're also easy to work with. Good Documentation Practice (Gap): Coordinate Regulatory Requirements in Pharmaceutical Manufacturing Industry Joymalya Bhattacharya, M. "At single-site operations, people are more inclined to work together, so that, for instance, the R&D chief knows the manufacturing guy," Jacobson observes. 5e6 September 2010. A Guide to Best Practice. Monitoring Blend Uniformity with Effusivity. In addition to pharmaceutical studies it finds an application in the analysis of biopolymer analysis and inorganic ions. E. , either in percent (%) or in parts per thousand (ppt). Babbage (1791 - 1871). A One concept related to Type II errors is "power. Knowing what you're up against can help you play it safe. The accidental ophthalmic administration of nonocular pharmaceutical products appears to be both under-reported and unrecognized in the international medical literature. 24 Among doctors depression and exhaustion are important. The measurement uncertainty provides complete information about an analytical result. Management, administration, process & equipment designers, internal regulators 12 The PowerPoint PPT presentation: "ERRORS IN CHEMICAL ANALYSES" is the property of its rightful owner. 2 In addition to causing serious morbidity and mortality, dispensing errors increase the economic burden on society by adding to health care costs. There are certain basic concepts in analytical chemistry that are helpful to the analyst when treating analytical data. 1 Oct 2010 These aspects are not trivial and can lead to serious errors if improperly performed. In practice, separation, identification or quantification may constitute the entire analysis or be combined with another method. Objective To assess the effect of a clinical pharmacist-led training programme on clinically relevant errors during intravenous medication preparation and administration in a Vietnamese hospital. Only registered delegates are allowed to present the e-poster in the 71st IPC 2019. ought to be detected by the normal analytical methods as it can lead to major error. Responsibility for the analysis presented lies entirely with the author, who is responsible for any After the peaks have been integrated and identified, the next step in the analysis is quantification. Over the past decade, there has been an increasing emphasis on quality by design (QbD) and the use of process analytical technology (PAT) to monitor and control pharmaceutical manufacturing processes. He has held senior management positions in QA, manufacturing, QC and supply chain auditing and Siegfried Schmitt, principal consultant, PAREXEL International, discusses how to find the root cause of the problem. What Current understanding of the costs of medication errors is highly incomplete. Precision refers to the reproducibility of a measurement while accuracy is a measure of the closeness to true value. 111 Huntington Avenue, 14th floor Boston, Massachusetts 02199 (617) 425-8491 genia. , sample. summarizes an analysis of causes of patient identification errors and identifies effective interventions for decreasing wrong We know from the literature that the majority of errors in this process occur at the physician-ordering step. These include procedure manuals, maintenance schedules, calibrations, a quality assurance program, training and quality control. , nurses reported 65. pharmaceutical products should therefore follow the WHO guide-lines for good manufacturing practices (GMP) (1). Recent review article on Pharmaceutical Inventory Models G. Measurement errors for semi-finished products and pharmaceutical active substances, should be Mar 11, 2010 · Medication errors like these can happen in any healthcare setting. Volume 1. int Stimulate reporting to a national system for review, analysis, and development of recommendations to reduce and ultimately prevent medication errors. this is in fact due to the blank signal (false positive, α error or type 1 error). Current Location > Formulas in Chemistry > Errors in Analysis > Minimization of Errors Minimization of Errors Analyst has no control on random errors but systemic errors can be reduced by following methods. 908, 2003, Annex 4. pharmaceutical analysis and cognate assays. Independent Analysis: Analysis using a "Reference Method" or Human errors have critical effects on pharmaceutical product quality. ppt Rolabo Pharmaceuticals won the case (and the rights to make Loratidine) Buoyancy errors – failure to correct for weight difference due to displacement of air  20 Jan 2010 Dispensing errors can be costly for the pharmacist as well as potentially dangerous for the patient. Understanding the contributing factors or causes of a system failure can help develop actions that sustain the correction. This can cause a nurse to administer a drug intended for a different patient; fatigue by the nurse and inadequate lighting of drug preparation and administration areas are also associated with such errors (Daniels, 2004). 5/11,D. Dec 30, 2018 · Basically there are three types of errors on the basis; they may arise from the source. Responsibility:QC personnel shall be responsible to follow the procedure as per SOP. In this article, we will use two examples to clarify what Type I and Type II errors are and how they can be applied. This is mainly used for the separation of the components from the mixture and for the determination of the structure of the compounds. Evaluation of analysis results (correctness, exactness, reproducibility) 8. For more difficult investigations, a Kepner-Tregoe or IS-IS NOT analysis can often tease out a challenging most probable root cause from an array of discordant facts. Chapter 1 Introduction to Pharmaceutical Analysis INTRODUCTION The pharmaceutical analysis is a branch of chemistry, which involves the series of process for the identification, determination, quantitation, and purification. About 80% of the product quality issues occur due to the human errors. Pharmaceutical analytical techniques deal with the process or different processes to identify and/or quantify a substance, the components of a pharmaceutical solution or mixture or the determination of the structures of chemical compounds used in the formulation of pharmaceutical product. CE analysis is generally more effective, can be performed on a quicker time scale, requires only a small amount, lesser up to Nano liter injection volumes, and in most cases, takes place under aqueous conditions. 3 million outpatient visits. This workbook explains and illustrates the basic A bioassay is an analytical method to determine concentration or potency of a substance by its effect on living cells or tissues. When the results of a study are surprising or contradict biological theory, a confirmatory trial may follow. 4 Redox titrations. Laboratory errors and corrective action preventive globalhealthlaboratories. quantity i. The Medicines Control Agency – Adverse Drug Reaction reporting 121 Dr June Raine 12. Materials and Methods: The current work is an effort to deliberate several aspects of finding the root cause for the OOS during the finished product analysis by using HPLC. Root cause analysis is a process for identifying the causes that underlie The Veterans Affairs root cause analysis system in action. " Power is the probability of rejecting H0 when H1 is true. Analysis of standard samples 2. According to the landmark 2006 report “Preventing Medication Errors” from the Institute of Medicine, these errors injure 1. The selection and proper use of problem solving models and analysis tools give greater probability and confidence that true root causes will be identified for proper action. The aim of this work was to evaluate and discuss the estimation of uncertainty in pharmaceutical analysis. Blend Analysis and Sampling Effects. The pharmaceutical business has globalized with modern drugs available in most countries in the world. Nethercote, Wiley VCH, Weinheim 2015 One of the best weighing practices in pharmaceutical industries in which one needs to understand is the measurement errors that may arise during the measurement process. 7. For an operational system, it is performed for specific suspect hazards. errors in pharmaceutical analysis ppt