Notebooks protocol

The slope of the land upon which the field trials will be established and the direction of the prevailing wind must be taken into consideration when locating the treated and untreated plots in a field trial. The protocol may specify a certain separation distance for the plots however, the PI must ensure that the plots are located with adequate separation to prevent contamination of the untreated plot during the course of the trial. The untreated plot must be located up-slope and up-wind from the treated plot to reduce contamination from wind or rain. When the land is level or the wind is not from a reasonably constant direction, then distance may be the only feasible way to ensure that plot integrity is maintained. Careful attention to plot placement in the field and documentation of this location in the field notebook will help minimize questions or concerns about the trial site during preparation of the final report. 

The mathematics involved with calculating the amount of active ingredient, formulated product, adjuvants, and water to put in a spray tank to achieve the application rate specified in the protocol should be addressed prior to arrival at the field for the first application. This is also true for the calibration method. The author has found that if eight agronomists are involved in a spray application, one will encounter eight distinct calibration methods. If a calibration SOP is not written for the spray equipment to be used, the precise steps in the calibration process should be documented in the field notebook. 

The GLP standards identify three types of deviations there are deviations from GLP standards, from the protocol, and from SOPs. Any deviation must be reported to the Study Director and documented in the raw data notebook. There are differences in the reporting process for the types of deviations. 

Protocol deviations in the processing phase of the study must be reported to the Study Director without delay. The Study Director will determine any potential impact upon the study that would result from the protocol deviation and will advise the PPI how to proceed with the study. Regardless of the form of communication by which the Study Director is notified of the protocol deviation, a formal description of the protocol deviation must be written by the PPI and submitted to the Smdy Director for an assessment of impact on the study. The assessment of impact by the Study Director should address any scientific and GLP compliance issues. A signed copy of the deviation report is included with the raw data notebook. 

If the PPI determines that there may be an impact on the study, the Study Director must be consulted promptly to determine the proper course of action. Any impact on the scientific aspect of the study resulting from an SOP deviation may generate a protocol deviation. Any impact on the GLP compliance of the study resulting from an SOP or GLP deviation will at the very least need to be addressed in the GLP compliance statement from the processing facility which is included in the raw data notebook. 

Today, much more than just data are produced electronically. Many documents needed for studies that fall under the Good Laboratory Practice (GLP) standards regulations are being managed electronically. These records include not only data, such as chromatographic data from automated electronic capture systems and raw data collected in electronic field notebooks, but also other documents, such as methods, protocols, reports and standard operating procedures (SOPs). Frequently, these records are generated, distributed, reviewed, and archived electronically. 

Tests to establish the identity, strength, and purity of the test and control articles need not comply strictly with GLP requirements (e.g., protocol, QAU inspection requirements), but good documentation of anal5dical test results (usually in a laboratory notebook) and retention of raw data for such tests is a good practice. As the development process proceeds and the same material is used in both nonclinical and clinical studies, CGMP principles wiU apply to the production and characterization processes. 

Documentation is critical for assessment. Standard protocols provide directions for what must be documented and how the documentation is to be done, including how to record information in notebooks. For labs that rely on manuals of standard practices, it is imperative that tasks done to comply with the manuals be monitored and recorded. Control charts (Box 5-1) can be used to monitor performance on blanks, calibration checks, and spiked samples to see if results are stable over time or to compare the work of different employees. Control charts can also monitor sensitivity or selectivity, especially if a laboratory encounters a wide variety of matrixes. 

A summary of all data and findings for the experiments listed in the validation protocol. This should include a complete listing of specific instrumentation, actual reagent lots, standards, equipment and supplies used in the performance of the validation. All results should be provided with references to the original notebook entries. Example chromatograms, spectra, or other instrument outputs should be provided. 

Log books, laboratory notebooks (when used), batch production and control records, qualification and validation protocols and reports, investigations of deviations and failures, and other GMP documentation must be carefully identified, controlled, and archived in a manner that will facilitate its prompt retrieval. 

As suggested by but not limited to, the list of SOP topics in 58.81(b) should be considered illustrative, not comprehensive. Many of the topics (e.g., laboratory tests) might involve 100 or more individual SOP titles. The range of topics for which SOPs are required will be governed by the variety of studies routinely conducted in the laboratory. For each procedure required by each type of study, the laboratory should prepare an SOP describing how that procedure should be performed. If a study activity is not yet standard or is intended to be a one-time event, it is acceptable to incorporate a detailed description of the how-to for that activity in the study protocol or in a laboratory notebook. If such activities become routine, however, an SOP should be prepared. 

Students who use this lab manual are laboratory technicians employed by a fictional consulting firm called the I.O.N.S. Corporation. The I.O.N.S. Corporation is directed by a chief executive officer by the name of Claire Hemistry, or C. Hemistry. The I.O.N.S. Corporation has a safety officer by the name of Ben Whell who issues a safety report for each project for which special safety considerations may be an issue. The instructor is the laboratory supervisor. Ms. Hemistry enters into contractual agreements with fictional clients that are faced with the problem or situation at hand. Industrial and academic consultants write memos giving the I.O.N.S. technicians the necessary background information. One of the consultants, the client, or Dr. Hemistry provides a standard operating procedure (SOP), or other procedure, that must be executed in order to solve the problem. The students then perform the lab work to solve the problem, keep a laboratory notebook according to company protocols, and write a report memo to the client on I.O.N.S. stationery reporting their results and recommendations, if appropriate. 

As product development can take several years to complete, it is important to have an effective document management system in place to record the work. The primary reference source for recording experimental work will usually be a laboratory notebook. The work should be checked, dated and counter-signed to satisfy GLP and intellectual property requirements. Experimental protocols are sometimes useful for defining programmes of work,... 

According to the recommended protocol, large objects such as rocks, metal, glass, wood, coal fragments, and other miscellaneous debris were noted in the field notebook and were removed from the core samples prior to homogenization. Only one sample out of 140 was free of miscellaneous debris, and coal tar was most likely present in all samples. Material heterogeneity complicates sampling and analysis. Furthermore, extreme contaminant concentration levels can occur at the micro and macro physical scales, for example, with coal tar. 

The validation documentation typically consists of a protocol, analytical data, and a final report. One approach to simplifying validation documentation is to focus on a thorough protocol with preapproved acceptance criteria, which are necessary to determine whether the validation results demonstrate that the method is fit for purpose. In early development, this protocol may be captured in a lab notebook which could be in either a paper or an electronic environment. There is an ever increasing trend in the use of electronic laboratory notebooks which makes it simple to execute previously developed protocols. Later in development, the protocol should be a unique document, which may have data tables to enter the test results, requiring only a short executive summary to summarize the results and a reference or attachment of raw data. A development lab will often use these well-developed and optimized master method validation protocols" " as templates for subsequent validations. A copy of the method procedure and, where available, a method development report may be appended to the validation protocol. In general, the validation protocol should contain the following ... 

Each computer-stored record has links to the Input which produced It. The date and test number are the primary links, but, to the extent possible, experiment number and/or notebook and page number are also recorded. The test number plus the protocol code serve to reference the file of protocols. An elaborate audit trail is kept for changes which need to be made In records. All accessory files are created within the department. 

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