Additionally, McKesson provides extensive network infrastructure for the health care industry ; also, it was an early adopter of technologies like bar-code scanning for distribution, pharmacy roboticsand RFID tags. The firm's name reverted to "McKesson" in
Method Validation is a concept which was introduced in the early 90 es. Before that, it was just stated in e. Validation of Analytical Procedures: And maybe it was inspired by this initiative within the pharmaceutical industry, that in the mid 90 es some European accreditation bodies started requesting analytical laboratories to perform something called validation of their methods although the concept didn t exist in the standard for accreditation EN The World of Method Validation was created and has been expanding ever since.
For most people in our modern society, this is an unknown Underground World as authorities, patients, consumers, patients etc. They leave it to the laboratories to secure, that results sent out for making any kind of decisions are reliable.
However, in the laboratories everybody are very much aware of the fact, that an analytical method is not just a cook-book taken down from the shelf to follow when performing the often complex work of applying a number of activities on a sample to finally come up with a number, which we can trust being usefull information about the content of a sample.
We know that the method must be scrutinized in many details to secure that it is fit for the purpose for which it is applied. The presentations given orally or by poster, for which the abstracts can be found in this booklet during this workshop illustrates very well how many forms and levels of details in the work of method validation the skilled people in various types of laboratories have to consider and tackle in dealing with validation studies.
During the 2-day workshop we shall hear and see about everything from validation of method for analysis of phtalates in toys to the challenges of replacing traditional microbiological methods for bacteria determination by modern bioanalytical techniques PCR.
From handling of multiparameter methods in the clinical laboratories to new possibilities of designing validation studies and use of chemometrics for data-evaluation. From dealing with validation of automated analytical systems to attempts on applying the principles of method validation to semi-quantitative and qualitative methods.
Indeed a fascinating world, the ever-growing World of Method Validation. Enjoy the tour together with a lot of good colleagues from all around the world Welcome Lorens P. Ellison, b Elin L. Morillas Bravo, d Stephen L.
Ellison, c Joakim Engman, e Elin L. Chmielna 2, Lublin, Poland. Wilk 2, Maurice C. Aalders 2, Christophe P. Methodology  later,combined to one guideline, Q2 R1.
Primarily for use in the pharmaceutical industry. As the requirements for doing something on the validity of methods applied among accredited analytical laboratories grew through the 90 s without the exact requirement being expressed in the standard yetEurachem decided to elaborate the well-known guideline The Fitness for Purpose of Analytical Methods A Laboratory Guide to Method Validation and Related Topics, which was issued in it s first version in .
Since then a multitude of guidelines and recommendations on how to plan, perform and evaluate a validation study has been elaborated. Some of them generic in their approach, some of them more sector specific e. Some of them following generally accepted approaches and concepts, some of them elaborating their own e.
Over the years the challenges to method validation have also increased in line with increased requirements to the methods, new technology, new areas of application etc. The Eurachem Guide came out in it s 2 nd version in and is aiming at having a generic approach to the methodology of method validation, and it s relevance has already been proven by the many downloads from the Eurachem website plus the fact, that it has already been translated into to other languages Farsi, Ukranian and Spanish and more are under way for securing understanding and implementation in the daily work in the laboratories around the world.
But the working group behind the guide MVWG is already working on an expansion, trying to follow up on the many challenges and need for guidance internationally the analytical laboratories are facing.
In Eurachem released a second edition of its Guide on method validation, devised to aid laboratories in demonstrating the fitness for purpose of test methods. In order to demonstrate fitness for purpose we first need to set requirements for the test results based on the client s requirements.
The client may need to 1 compare two different treatments of a product under development, 2 assess whether the process control shows that the production is in control 3 assess whether a production batch meets specifications, 4 decide whether a legal limit has been exceeded, e.
Based on the client s requirements we need to develop a sampling plan, choose a test and set the requirements. Last year Eurachem released a Guide providing guidance to analysts, regulators and other end-users of analytical information on setting the target measurement uncertainty.
In cases 3 and 4 above the key analytical requirement is the uncertainty but in case 1 and 2 the key requirement is only the precision. In case 1 the key requirement is the repeatability providing that all tests can be performed the same day. In case 2 the key requirement is the intermediate precision which in this case is the within-laboratory reproducibility.
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The interrelation between these requirements is shown here in a ladder where measurement uncertainty includes all steps. The presentation will address how to set the analytical requirements in the typical cases 1 to 4 described above.iso kalite yönetim sistemi iso iso belgesi nedir iso belgesi ıso iso belgelendirme iso nedir ıso belgesi ohsas iso hac.
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