The good laboratory practice guidelines glp have been in existence for nonclinical safety studies since 1976. The front and back book covers insides have conversion tables to be opened or flipped to quickly as a reference. To good laboratories, these best practices become routine procedures. After more than twenty years of use good laboratory practice, or glp, has attained a secure place in the world of testing chemicals and other test items with regard to their safety for humans and the environment. It is also important to maintain a good laboratory notebook in order to protect your intellectual property e. If you make a writing error, dont scribble it out but draw a line through it make the correction and intial and date near the correction. A laboratory notebook is an important tool that goes well beyond research management, and keeping good records has implications for issues ranging from intellectual property management to the prevention of fraud. This part describes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the food and drug administrationcompliance with this part is. Glp aims to ensure the consistency, reliability, uniformity, and quality of chemical nonclinical safety tests. Whether you are a research scientist, an engineer, or a firsttime science fair student, you should use a lab notebook to document your science investigations, experiments, and product designs. A better way to think of a lab book, is as a journal. This course will be of benefit to anyone who needs a foundational understanding of fda good laboratory practices. Having confidence in scientific procedures and data is the sine qua non for determining the safety of chemicals and chemical products. Finally, we will show some examples of what a good lab notebook looks like.
To support patent activities, it is necessary for your lab book to provide clear, concise, chronological entries with specific dates. After more than twenty years of use good laboratory practice, or glp, has attained a secure place in the world of testing chemicals and other test items with regard to. Keeping a complete and accurate record of experimental methods and data is a vital part of science and engineering. After more than twenty years of use good laboratory practice, or glp, has attained a secure place in the world of testing chemicals and other test items with regard to their safety for humans and th. Glp is a formal regulation that was created by the fda. Glp good laboratory practices good laboratory practice or glp specifically refers to a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical including pharmaceuticals non clinical safety.
Dec 09, 20 good laboratory practice or glp is a set of principles intended to assure the quality and integrity of nonclinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies. While formats vary for tables of contents, the important information remains the same. A lab book is not just a place to write down meausrements here and there. Do not copy the words from this example into your notebook some of the experimental. It is a quality system which intends to ensure through careful and accurate documentation, covering all aspects of study and of its environment, the quality, integrity and reliability of safety data. The work may be ancient history but as an example of recordkeeping this mateiral may be far more effective than general guidelines in delivering the message. Writing your lab book is easy to put off as it never seems quite as important as. Instructions for using your laboratory notebook mit. Keep a great science or engineering project laboratory notebook. Here are examples of a title page and specific notebook entries. Your laboratory notebook is a permanent record of what you did and. A practical guide offers a systematic and straightforward handbook for obtaining high quality preclinical good laboratory practice glp studies.
In some teaching laboratories, especially at the high school level, it is taught that a good lab book has a defined structure. In the experimental nonclinical research arena, good laboratory practice or glp is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical including pharmaceuticals nonclinical safety tests. The term refers to a quality system of management controls for laboratories where research is taking place. An appropriately maintained laboratory notebook can often mean the difference between gaining or not gaining recognition for a discovery. This is usually considered bad laboratory practice. You see here an example of a table of contents from a lab notebook. Food and drugs administration fda list of fda inspections of facilities that perform nonclinical laboratory studies. A free powerpoint ppt presentation displayed as a flash slide show on id. The following is a general description of how to keep a proper laboratory notebook.
Nonclinical study contracting and monitoring sciencedirect. Ppt good laboratory practices powerpoint presentation. Documentation is best lab practices beyond the simple chemis. The authors tone is filled with humor and is not pretentious. Good laboratory practice when performing molecular amplification assays introduction this guidance note describes key elements of how to organise facilities for polymerase chain reaction pcr testing including workflow, reagents, consumables and staff within a molecular diagnostic laboratory2. While we make particular reference to laboratory notebooks, similar principles may be adopted by engineers, software developers, industrial designers and backyard inventors.
Record everything you do in the lab, even if you are following a published procedure. An introduction to good laboratory practices glp life. The notebook is a legal document that can protect your rights to your work. Loose data should be kept in a separate folder or notebook, with location noted in the book. In constructing various laboratories throughout the years, hendrick construction charlotte, nc has found that certain challenges arise in many projects. Good laboratory practices for molecular genetic testing for. The demand for this series was so substantial that it became one of the most frequent hits. More generally, recording what you did, what you found, who. We are not aware of any research notebooks that have this structure. Keeping a lab notebook is essential good practice for any scientist. A lab notebook is an important part of any research or engineering project. Nonclinical good laboratory practice also refers to experimental research. It is a quality system which intends to ensure through careful and accurate documentation, covering all aspects of study and of its environment, the quality, integrity and.
If you can answer yes to these two questions, you are keeping a good notebook. This part describes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the food and drug administrationcompliance with this part is intended to assure the quality and integrity of the safety data. Laboratory notebooks are extremely important in support of documenting work that may be patented. Good laboratory notebook practices columbia research. Consequently, learning how to keep a useful, meaningful lab book is an essential. For example, in a published article we dont report centrifuge type, rpm, rotor type, or which machine was. I got my act together and forced myself into a good lab book routine. Good clinical laboratory practices gclp should be used by all laboratories where tests are done on biological specimens for diagnosis, patient care, disease control and research. Use the manufacturers product insert for the kit currently in use. Guidelines for keeping a laboratory record if you have built a perfect demonstration do not remove all traces of the scaffolding by which you have raised it.
For decisions of safety, there must be rigorous and thorough application of fundamental scientific practices, irrespective of the purpose of the study and where it is conductedacademic, industry, or a contract laboratory. This report also is intended to be a resource for users of laboratory services to aid in their use of molecular genetic tests and test results in health assessment and care. This book is full of realworld examples, processes, procedures, useful templates, checklists and sample reports to provide readers with a better. Note that professor azuma has two clear opinions on some of the conventions of his software environment. Daids guidelines for good clinical laboratory practice standards. Good laboratory practice training manual for the trainer. Keeping a good laboratory record book dr roland smith.
Label and date everything and include your initials 2. Instructions for using your laboratory notebook please read before coming to lab 3. Daids guidelines for good clinical laboratory practice standards effective date. It is taken from the book, writing the laboratory notebook by howard kanare. Aug 25, 2010 good clinical laboratory practices gclp should be used by all laboratories where tests are done on biological specimens for diagnosis, patient care, disease control and research. The keeping of detailed records of your work is essential both as a student and as a professional scientist. This is a series of notes on some of the computer issues relating to these experiments. Daids guidelines for good clinical laboratory practice. For example, if you beat another lab to a patentable discovery by just one day, your notebook will be the legal proof you need.
Good laboratory notebook practice is just one way to comply with the. As part of first year laboratory course you are required to keep a lab book. The proven marks of modern laboratory design are sharing of resources, flexible use of space, and the ability to adapt to changing needs. Jan 22, 2014 the good laboratory practice guidelines glp have been in existence for nonclinical safety studies since 1976. Although the duties of the head of the laboratory are many, some may be delegated and others undertaken by other parts of the food control administration.
Good laboratory notebook practice is just one way to comply with the much larger concept of good laboratory practice. Next we show a sequence of three successive pages for the lab book. Why is it important to keep a good laboratory notebook. For example, if you started by obtaining a quantity of tissue from an instructor, then write down that you obtained tissue, describe it, note how much, what condition, etc. Did your sample look different from normal or was the machine you were. Guidelines for keeping a laboratory notebook rice university.
This editorial is not meant to discuss anything new but to emphasize the well accepted guidelines for gclp. Science and engineering project laboratory notebooks. Examples of notebook pages and entries rice university. Glp good laboratory practices good laboratory practice or glp specifically refers to a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical including pharmaceuticals non clinical. However, generally, individuals who use laboratory notebooks are from research and development, quality engineering, manufacturing engineering, and testing laboratories departments. This book is over 900 pages and has a ton of photos both for techniques and presentations. The laboratory head may have to give evidence in court or write documents used in court, in which. Good laboratory practice the why and the how springerlink. Good laboratory practice or glp is a set of principles intended to assure the quality and integrity of nonclinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies. Good laboratory practice glp regulations and guidelines. The date the entry was made, the subject of that entry, and where in the lab notebook that entry can be found. Keeping a lab notebook national institutes of health.
An srm must be fit for its intended use, for example. Record how you choose to label your samples at the beginning of your lab book so that anyone looking in your lab book will be able to easily find the information they are looking for about a specific sample and vice versa. This includes scientists, quality professionals, regulatory affairs personnel, preclinical and clinical trials professions, and anyone who is looking for a basic refresher. Scope this standard operating procedure sop applies to the staff and students of the pharmacy department to follow the good laboratory practice glp. Good laboratory practices 1 keep the manufacturers product insert for the laboratory test in use and be sure it is available to the testing personnel. Here is a quick rundown on lab book layout, examples of format and other lab book. The importance of planning and coordination in laboratory design. Jan 01, 2005 however, generally, individuals who use laboratory notebooks are from research and development, quality engineering, manufacturing engineering, and testing laboratories departments. In an analytical chemical laboratory for a quantitative analysis, a series of reference materials with known elemental contents encompassing the analysis range of interest. Guidelines for keeping a laboratory record rice university. Never do calculations or record observations on lab stationery paper.
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