INTRODUCTION:
Good Laboratory Practice is a quality standard where there is an implementation of designed laboratory studies and this is reported to ensure the result is uniform, consistent, reliable and also reproducible with quality and integration of chemical nonclinical tests of safety. There are proper procedures and protocols in GLP which are to be implemented by the laboratory
GLP includes following:
1. Good laboratory management (including quality management)
2. Improved efficiency (cost reduction)
3. Errors are minimized
4. Quality control (tracking of errors and their cause)
5. Motivation given to all personnel
6. Improvement of Safety
7. Improvement of communication including internally and externally.
GLP is a quality system concerned
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c) Avoids duplicative testing
d) Is beneficial to animal welfare
e) Reduces costs for industry and governments.
GLP is a regulated system. It is not only good analytical practice. It is not enough to have Good analytical practice though it is important. Taking an example of a laboratory it should consist of a particular organizational structure and protocols to carry out and document laboratory work. Traceability and integrity of data are also important along with the quality of the data. The type and amount of documentation forms the major difference between GLP and Non-GLP.
GLP inspector looks after documentation and to easily find out the following:
• Person who has done a study,
• The overall procedure on how the experiment was carried out,-
• Which procedures have been used in the experiment, and
• Any problem faced and if so
• How it has been solved.
There are few requirements of a GLP system which are as follows:
• Responsibilities should be assigned for the management of sponsor, study and quality assurance unit.
• Standard operating procedures should be defined to all the routine
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• Verification and Authentication of toxicology test are done which are recorded and can be used for reconstructions.
• There is a separate department of Quality Assurance to check whether the work done has been followed in accordance with the regulations, protocols and internal procedures.
Differences has been observed as below:
• GLP has unique roles and responsibilities, including study director and principal investigator.
• .Planning and Execution of studies have been done according to approved plans.
• A list or master data schedule is maintained of all studies and protocols running in the testing facility to help coordinate the running of the studies. A regular update must be taken especially on monthly basis which is very important in GLP regulations.
• Raw data is the method used for the records generated in the course of a study.
• Formal archive is present with an archivist who is responsible for maintaining the study records stored within it.
GLP principles include
1. Principles related to organization and at personnel
• Responsibilities of the
The lab started off by measuring critical materials for the lab: the mass of an an empty 100 mL beaker, mass of beaker and copper chloride together(52.30 g), and the mass of three iron nails(2.73 g). The goal of this experiment is to determine the number of moles of copper and iron that would be produced in the reaction of iron and copper(II) chloride, the ratio of moles of iron to moles of copper, and the percent yield of copper produced. 2.00 grams of copper(II) chloride was added in the beaker to mix with 15 mL of distilled water. Then, three dry nails are placed in the copper(II) chloride solution for approximately 25 minutes. The three nails have to be scraped clean by sandpaper to make the surface of the nail shiny; if the nails are not clean, then some unknown substances might accidentally mix into the reaction and cause variations of the result.
Hi Prof. Antoisnne, It is imperative that the HIM professional establish data standards to ensure data quality and consistency. Establishing data standards would help to ensure patient safety, consistent delivery of health care services, plan coordination of care, and standardize healthcare reporting. Essentially, data standards are needed to assess the quality and consistency of collected data. Organizations need HIM professionals to familiarize themselves with these standards to create an organizational standardized data dictionary, format electronic health records, and standardize the exchange of health information across the continuum for general data management and to ensure the integrity and reliability of gathered data.
Introduction: Enzymes are needed for survival in any living system and they control cellular reactions. Enzymes speed up chemical reactions by lowering the energy needed for molecules to begin reacting with each other. They do this by forming an enzyme-substrate complex that reduces energy that is required for a specific reaction to occur. Enzymes determine their functions by their shape and structure. Enzymes are made of amino acids, it 's made of anywhere from a hundred to a million amino acids, each they are bonded to other chemical bonds.
Contents Terms of Reference 2 Procedure 2 Findings 3 Current Structure 3 New Structure 4 Employee Relationships 4 Instructing Staff 5 Contingency Variables 5 Conclusion 6 Recommendations 6 References 7 Appendix A 8 Terms of Reference I am a HNC business student. I am writing this report as part of my course. This assessment covers outcome 4 of the Managing People and Organizations' class.
I will list some of the key components that I feel is important within the sections. 1. Benchmarking Team
In order to improve employee morale and satisfaction,
( this is an analysis that is done by a Toxicologist).
Purpose: To inform the audience about animal testing I. Introduction A. Attention getting device: Approximately 26 million animals are used every year in US laboratories for cosmetic and biomedical research. B. Thesis: I would like to inform you about how animal testing is conducted. C. Credibility: I have read and studied the articles about animal testing. D. Preview: I am going to share with you purposes of animal testing, how animals are used in laboratory tests, and the effectiveness of animal testing.
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Organization structure – The whole activies are divided in the department and the responsibility and hirenchy of each department is well defined. However Senior management needs to be more focused on Strategic Initiative rather than Daily Operations .For this it is Important to develop a second Rung of Leadership. Human Resource Plan – The Human resourse plant is defined for all the employee and the system for the recruiting , training & development, benefits and reward is well established.
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• Meet design specificstion • Impact on the customer • Benefits to the
The use of communication and unity are the key characteristics for a well- run organization. This reenterates the statement made by O’Toole and _____ involvement from managers enforces subordinates to move forward in a more suitable manner. Consequently organizational structure is necessary for a well implemented
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