Good weighing practice in pharmaceutical industry pharmacy. Implementing best weighing practices assures high product quality and lowers the risk of analysis. Correct testing saves costs with good weighing practice gwp performance verification of weighing equipment is now secure. Good weighing practice is a guideline that allows you to improve control of your whole measuring process. Recommend article pdf version print bookmark article. These regulations are the subject of this handbook, which is a reference and. A best practice is a method or technique that has been generally accepted as superior to any alternatives because it produces results that are superior to those achieved by other means or. Good distribution practice gdp requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable.
Good weighing practice webinar the first part of this webinar deals with the cornerstones for evaluating and selecting an. Good weighing practice the global weighing guideline part 1. Thus, the same scientific principles of managing weighing equipmentsummarized in gwp good weighing practice, mettler toledoapply for production and. Aug 31, 2010 good weighing practice puts the regulations applicable to your industry into practice and represents riskfree weighing, as it guarantees the safety and quality of your weighing system. Pdf 8 recommended form of reporting tape calibrations oct 2014 doc pdf 9 equations for metallic tapes oct 2014 doc pdf 10 understanding factors affecting weighing operations may 2019 docx pdf 11 assignment and adjustment of calibration intervals for laboratory standards may 2019 job aids. Gwp good weighing practice weighing instrument guideline. Good weighing practice in modern industry brady systems. Sop on good laboratory practices glp pharmaceutical. Best weighing practices in the pharmaceutical industry. Balances and weighing systems qualification process qualification process can be described as set of activities which aim at confirmation with rules of good manufacturing practice, that. Good weighing practice global weighing standard mettler toledo. Gwp stands for good weighing practice weighing instrument guideline. Good documentation practices gdps in pharmaceutical industry. Good documentation practices gdps in pharmaceutical industry author.
Good weighing practices for the food industry food quality. How is good weighing practice weighing instrument guideline abbreviated. Weighing plays a fundamental role in research, development, quality assurance, and production. This class will count toward 1 pdh for pe continuing education credit. Reliability of our weighing systems and compliance with gmp guidelines are crucial factors. This standard operating procedure is applicable to quality control department followed at pharmaceutical company. Good laboratory practices for pharmaceutical quality. Kevin hill heads the marketing efforts at quality scales unlimited in byron, ca, email protected. Every product sales representative at mettlertoledo uses software, which is based on the metrological principles stated in good weighing practice. How to create a result report both as a pdf and on a strip with a msts laboratory balance duration. Part 1 talks about good manufacturing practices and how they relate to accurate and.
Good manufacturing practice and good distribution practice. Nov 26, 2014 this video is part 1 of a longer presentation given by michael taylor of mettler toledo. Another best weighing practice in pharmaceutical industries is the balance routine examination. To lay down a procedure for operation of hot plate. Nov 09, 2011 good weighing practice the global weighing guideline. Content significance of balances in the qc laboratories types of balances definition minimum weight location for installation balances usp requirement performances test calibration repeatability linearity eccentricity sensitivity. Good practice in the pharmaceutical industry in pharmacies, accurate weights are critical in order to produce a highquality end product. Good weighing practice for lab and production balance biochem. Good weighing practices in qc lab linkedin slideshare. The 5 subsequent steps of the good weighing practice lifecycle match and complement the principles of lean. Good weighing practice is actually an integral part of the good manufacturing practice gmp for production purposes and good laboratory practice glp for laboratories. Good documentation practices gdps in pharmaceutical.
Gwp principles were defined in order to improve the weight measuring process in production as well as in the laboratory of the pharmaceutical and biotechnology companies. The understanding of weighing process requirements is essential to select an appropriate weighing device in the framework of the design qualifi cation 2. This video is part 1 of a longer presentation given by michael taylor of mettler toledo. This document is intended as a guide to the best practice to be adopted when carrying out weighings in the pharmaceutical industry. Good weighing practice webinar the first part of this webinar deals with the cornerstones forevaluating and selecting an appropriate weighing. Good weighing practice in modern industry part 1 youtube. It is based on a defined set of activities that begin with an evaluation of your risks, recommend appropriate actions and lead to safe routine operation. Good weighing practice puts the regulations applicable to your industry into practice and represents riskfree weighing, as it guarantees the safety and quality of your. Good weighing practices for the food industry food. Guidelines on good laboratory practices for pharmaceutical quality control laboratories in lebanon 2016 edition 1 341 introduction the good laboratory practice provide advice on good practices for national pharmaceutical control laboratories involved in the analysis of active pharmaceutical ingredients apis. Gwp good weighing practice life cycle management 5 steps that support the lean. Following these practices will help in attaining accurate weighing results.
Guidelines on good laboratory practices for pharmaceutical quality control laboratories in lebanon 2016 edition 1 541 batch number or lot number a distinctive combination of. Good weighing practices for the food industry page 4 of 5. Eudralex volume 4 good manufacturing practice gmp guidelines volume 4 of the rules governing medicinal products in the european union contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in commission directives 956eec. Accurate weighing results gwp good weighing practice.
Optimum weighing results with its riskbased approach, gwp has 5 key steps that helps you make the right decisions where it really matters, covering all important stages of the weighing. Good weighing practice webinar linkedin slideshare. To ensure the accuracy of weighing results, balances should be inspected, calibrated and. Do the glps apply to validation trials conducted to. Scribd is the worlds largest social reading and publishing site. Following the good weighing practice scientific standard helps you to select the right. Established in 2007 by mettler toledo, gwp is a standardized methodology for the secure selection, calibration and operation of weighing equipment. As a consequence we place more emphasis on control when the risk is high and save costs where the risk is low. New manufacture of biological active substances and medicinal products for human use into operation since 26 june 2018. Jun 18, 20 good weighing practice is actually an integral part of the good manufacturing practice gmp for production purposes and good laboratory practice glp for laboratories. Guaranteed quality minimized risk reduced costs secure audits. The principles of good laboratory practice of the organisation for economic cooperation and development.
By implementing good weighing practice tm as a methodology to provide a riskbased life cycle approach for evaluation, selection, and routine testing of balances and scales, measurement. The company can either place schedule test intervals on the balance and ensure that it is operating properly at all times, or they can be testing the balance. Kumar k 2017 good documentation practices gdps in pharmaceutical industry. Balances and weighing systems qualification process qualification process can be described as set of activities which aim at confirmation with rules of good manufacturing practice, that procedures, processes, devices, substances, and systems are used in a way which gives expected results. Weighing in the pharmaceutical industry national physical. Part 1 talks about good manufacturing practices and how they relate to accurate and efficient weighing. Content significance of balances in the qc laboratories. Instruments designed for measuring, weighing, weighing records and control should.
The pertinent regulations in the preclinical scenario are the good laboratory practice glp regulations. Bedside nurses are ultimately managing urinary catheters, which is perceived to be advantageous because it reduces the amount of time they must. Good weighing practice in pharmaceutical industry free download as pdf file. Nov 22, 2017 implementing best weighing practices assures high product quality and lowers the risk of analysis. Good weighing practices for the food industry page 4 of. In this weeks blog, we talk about the weighing practices. Applying mindful evidence based practice at the bedside. Routine tests are performed according to the intervals that are accepted by the. Good weighing practice webinar the first part of this webinar deals with the cornerstones forevaluating and selecting an appropriate weighing system. Good weighing practices for the pharmaceutical industry riskbased qualification and life cycle management of weighing systems. Routine tests are performed according to the intervals that are accepted by the company.
Gwp is defined as good weighing practice weighing instrument guideline frequently. To ensure the accuracy of weighing results, balances should be inspected, calibrated and tested at regular intervals. Good practice guideline obtaining an accurate body weight. Krishan kumar, laboratory for translational research in imaging pharmaceuticals. Thus, the same scientific principles of managing weighing equipmentsummarized in gwp good weighing practice, mettler toledoapply for production and quality control. The difference is that usp explicitly requires a weighing tolerance of 0. Good laboratory practices for pharmaceutical quality control.
Good weighing practice gwp is a global standard that ensures consistent accuracy, quality and compliance in any weighing process. Measurement uncertainty and minimum weight by mettler toledo int. Guaranteed quality minimized risk reduced costs secure. By implementing good weighing practice tm as a methodology to provide a riskbased life cycle approach for evaluation, selection, and routine testing of balances and scales, measurement errors in a lean laboratory can be reduced and reliable weighing processes can be realized ensuring a steady workflow with accuracy over time. These regulations are the subject of this handbook, which is a reference and support document, to help in the implementation of glp. Annex 1 who good practices for pharmaceutical quality. In this weeks blog, we talk about the weighing practices that every pharmaceutical company should implement.
All weighing equipment should be recorded on the medical devices inventory and the accuracy checked using traceable calibrate d weights. Good documentation practice gdp guideline 1 contents 1. Throughout the industry, there are common misconceptions regarding balance selection and use as well a. Dec 18, 2014 good distribution practice gdp requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by. Cosmetic good manufacturing practice guidelines the federal food, drug and cosmetic act prohibits the introduction or delivery for introduction into interstate commerce of cosmetics. Good weighing practice how is good weighing practice. This article introduces a scientific methodology for selecting and testing weighing instruments within an integrated qualification approachgood weighing practices.
Each hospital or healthcare premises should procure all weighing equipment centrally rather than on a ward by ward basis, ideally by the department responsible for maintaining the equipment. Sop on good laboratory practices glp pharmaceutical guidance. This good practice guide is intended as a useful reference for those involved in the practical. With good weighing practice gwp, mettler toledo has developed a global weighing guideline for the evaluation, operation and testing of weighing systems. Erik volek of mettler toledo will be presenting an educational class on good weighing practice in modern industry. All new weighing equipment purchased for the purposes of weighing patients should achieve a class iii standard or higher. Good weighing practice the global weighing guideline. Good weighing practice enables us to evaluate the risks associated with the weighing processes. Good weighing practice webinar the first part of this webinar deals with the cornerstones for evaluating and selecting an appropriate weighing system. Complying with revised weighing guidelines pharmaceutical.
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