Guidelines for keeping a laboratory notebook rice university. Jan 01, 2005 however, generally, individuals who use laboratory notebooks are from research and development, quality engineering, manufacturing engineering, and testing laboratories departments. A better way to think of a lab book, is as a journal. 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. This book is full of realworld examples, processes, procedures, useful templates, checklists and sample reports to provide readers with a better. A free powerpoint ppt presentation displayed as a flash slide show on id. 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. 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. Good laboratory notebook practices columbia research. Food and drugs administration fda list of fda inspections of facilities that perform nonclinical laboratory studies.
Having confidence in scientific procedures and data is the sine qua non for determining the safety of chemicals and chemical products. 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. 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. It is taken from the book, writing the laboratory notebook by howard kanare. A lab book is not just a place to write down meausrements here and there. Record everything you do in the lab, even if you are following a published procedure. 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. Never do calculations or record observations on lab stationery paper.
Guidelines for keeping a laboratory record rice university. Good laboratory practice the why and the how springerlink. A lab notebook is an important part of any research or engineering project. Note that professor azuma has two clear opinions on some of the conventions of his software environment. To good laboratories, these best practices become routine procedures. Instructions for using your laboratory notebook mit. Glp is a formal regulation that was created by the fda. Scope this standard operating procedure sop applies to the staff and students of the pharmacy department to follow the good laboratory practice glp. Loose data should be kept in a separate folder or notebook, with location noted in the book. An introduction to good laboratory practices glp life.
The keeping of detailed records of your work is essential both as a student and as a professional scientist. For example, if you beat another lab to a patentable discovery by just one day, your notebook will be the legal proof you need. Laboratory notebooks are extremely important in support of documenting work that may be patented. Did your sample look different from normal or was the machine you were. The term refers to a quality system of management controls for laboratories where research is taking place. 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. It is also important to maintain a good laboratory notebook in order to protect your intellectual property e. In an analytical chemical laboratory for a quantitative analysis, a series of reference materials with known elemental contents encompassing the analysis range of interest. This includes scientists, quality professionals, regulatory affairs personnel, preclinical and clinical trials professions, and anyone who is looking for a basic refresher. Ppt good laboratory practices powerpoint presentation. 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.
This book is over 900 pages and has a ton of photos both for techniques and presentations. Good laboratory notebook practice is just one way to comply with the much larger concept of good laboratory practice. The front and back book covers insides have conversion tables to be opened or flipped to quickly as a reference. 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. Keeping a complete and accurate record of experimental methods and data is a vital part of science and engineering. Nonclinical study contracting and monitoring sciencedirect. The laboratory head may have to give evidence in court or write documents used in court, in which. Keeping a lab notebook national institutes of health. Consequently, learning how to keep a useful, meaningful lab book is an essential. As part of first year laboratory course you are required to keep a lab book. 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. An appropriately maintained laboratory notebook can often mean the difference between gaining or not gaining recognition for a discovery. Finally, we will show some examples of what a good lab notebook looks like. 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.
Keeping a lab notebook is essential good practice for any scientist. A practical guide offers a systematic and straightforward handbook for obtaining high quality preclinical good laboratory practice glp studies. Documentation is best lab practices beyond the simple chemis. 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.
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. Use the manufacturers product insert for the kit currently in use. Your laboratory notebook is a permanent record of what you did and. Jan 22, 2014 the good laboratory practice guidelines glp have been in existence for nonclinical safety studies since 1976. The notebook is a legal document that can protect your rights to your work. The good laboratory practice guidelines glp have been in existence for nonclinical safety studies since 1976. Science and engineering project laboratory notebooks. Nonclinical good laboratory practice also refers to experimental research. The authors tone is filled with humor and is not pretentious. Writing your lab book is easy to put off as it never seems quite as important as. You see here an example of a table of contents from a lab notebook. 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. However, generally, individuals who use laboratory notebooks are from research and development, quality engineering, manufacturing engineering, and testing laboratories departments.
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. We are not aware of any research notebooks that have this structure. 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. The importance of planning and coordination in laboratory design. The proven marks of modern laboratory design are sharing of resources, flexible use of space, and the ability to adapt to changing needs. To support patent activities, it is necessary for your lab book to provide clear, concise, chronological entries with specific dates. This is a series of notes on some of the computer issues relating to these experiments. This course will be of benefit to anyone who needs a foundational understanding of fda good laboratory practices. In constructing various laboratories throughout the years, hendrick construction charlotte, nc has found that certain challenges arise in many projects. The demand for this series was so substantial that it became one of the most frequent hits.
Good laboratory practice glp regulations and guidelines. 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. Daids guidelines for good clinical laboratory practice standards effective date. 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. Why is it important to keep a good laboratory notebook. In some teaching laboratories, especially at the high school level, it is taught that a good lab book has a defined structure.
Examples of notebook pages and entries rice university. The following is a general description of how to keep a proper laboratory notebook. 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. Daids guidelines for good clinical laboratory practice standards. Good laboratory practice training manual for the trainer. If you can answer yes to these two questions, you are keeping a good notebook. Next we show a sequence of three successive pages for the lab book. Good laboratory notebook practice is just one way to comply with the. This is usually considered bad laboratory practice.
Here are examples of a title page and specific notebook entries. More generally, recording what you did, what you found, who. While formats vary for tables of contents, the important information remains the same. Do not copy the words from this example into your notebook some of the experimental. For example, in a published article we dont report centrifuge type, rpm, rotor type, or which machine was. 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. The date the entry was made, the subject of that entry, and where in the lab notebook that entry can be found. 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. 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. Keeping a good laboratory record book dr roland smith.
Here is a quick rundown on lab book layout, examples of format and other lab book. 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 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. Keep a great science or engineering project laboratory notebook. 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. This editorial is not meant to discuss anything new but to emphasize the well accepted guidelines for gclp.
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