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The Master Schedule

The master schedule, according to its definition, has in the first instance to give information about the workload at the test facility. For it to become a true instrument to gauge the actual workload, the master schedule has to contain information on all studies performed or planned at this test facility, and not on the GLP studies only. It would certainly be advisable to mark or distinguish GLP conforming studies from others, since these will be those most rele- [Pg.100]

But let us look at the issue of the master schedule also from the other side Its existence will allow the Compliance Monitoring Authority to judge whether the test facility management did comply with its obligations, having provided adequate facilities and technical resources as well as a sufficient number of personnel for the performance of the studies that have been conducted. [Pg.101]

GLP studies planned through submit of their draft study plans and [Pg.102]

At the same time, it will enable Quality Assurance to better plan their respective activities in relation to the conduct of GLP studies. In laboratories, where only rarely true GLP studies are performed, the existence of a full and up-to-date master schedule at the Quality Assurance office will allow for the planning of inspections at such times, when non-GLP studies of a similar type are conducted, thus allowing the Quality Assurance inspector to better judge the GLP compliance of the everyday work at this test facility. [Pg.102]


Preparation In preparing for an audit, all data and documentation for the study are assembled for the inspectors to view (Figure 8.3). The study director, or other designated technical contact, should review the files and prepare to answer any questions. The master schedule and all files assembled by the quality assurance unit should be reviewed. An agenda, a work space, and a test facility floor plan should be prepared for the inspectors. The staff should be fully briefed and prepared for the visit. [Pg.76]

The FDA believes that maintenance of a detailed master schedule sheet is essential to the proper functioning of the QAU. In actual practice few QA groups use the master schedule in the performance of QA functions. Few do more than maintain a master schedule for the benefit of FDA inspectors, who use it to gauge the volume of GLP-regulated work being conducted by a laboratory and to aid in the random selection of studies for review during an inspection. [Pg.61]

There is no requirement for the QAU to prepare the master schedule. The master schedule may be prepared by some organizational imit other than the QAU as long as the QAU maintains a copy in its files. [Pg.61]

The FDA has indicated that a study should first appear on the master schedule on the date the protocol is signed by the study director. A study may come off the master schedule when the final report of the study is signed by the study director. [Pg.61]

In the preamble I 8 and 13) to the 1987 GLP revisions [4] the master schedule was referred to as raw data. In a subsequent clarification, Dr. Paul Lepore indicated that the term raw data had appeared in quotes in the preamble to indicate that the term was not being used as defined in 58.3... [Pg.61]

Additional language in the preamble 15) to the GLP revisions of 1987 [4] as well as enforcement pohcies of individual FDA investigators have broadly interpreted the requirement to include the current status of each study on the master schedule. According to this view, the master schedule should include such study events as test article-mixture preparation, test system dosing, and in-hfe observation. Because such detailed information is usually available in other study documentation (e.g., protocol, study schedules), most laboratories hmit a description of current status to broad categories such as in-hfe phase, study terminated, report preparation, and report issuance. ... [Pg.62]

It is permissible to identify the sponsor on the master schedule by code rather than by name. This allows a contract laboratory to protect chent confidentiahty if the master schedule is examined by one of many clients. The contract laboratory must, however, make the names of sponsors available to FDA upon request. [Pg.62]

Many laboratories maintain the master schedule on computer, and find it a helpful tool for the allocation of resources and the scheduling of work. A computerized master schedule can also provide the index of archive materials required by 58.190(e) of the regulations. [Pg.62]

A study or studies that must comply with the GLPs have not been listed on the master schedule. Numerous less serious GLP deviations that persist over two or more inspection periods. This suggests that the laboratory is out of control. [Pg.218]

Some may question how the inspected laboratories rated in terms of comphance to each of the 141 operational provisions of the GLPs. The information accumulated from the Center for Drug Evaluation and Research indicates that 66% of the inspected laboratories were cited for one or more deviations from these provisions. The most significant departures from the GLPs were (1) final reports did not conform to the raw data (2) improper correction of the raw data (3) protocol revisions were implemented without amending the protocols (4) the absence of required SOPs and the failure to amend SOPs when necessary and (5) the master schedule sheets and the protocols did not contain the information required by the regulations. [Pg.221]

The principles of GLP require an independent quality assurance (QA) program to ensure that the study is being conducted in compliance with GLP. The QA personnel cannot overlap with those of the study because of the potential conflict of interest, but they may be part-time staff if the size of the study does not warrant a full-time QA section. The responsibilities of the QA unit are to maintain copies of plans, standard operating procedures, and in particular the master schedule of the study, and to verily, in writing, that these conform to GLP. The QA unit is responsible for inspections and audits, which must be documented and the results made available to the study director and the principal investigator. The QA unit also signs off on the final report. Any problems discovered or corrective action that is recommended by the unit must be documented and followed up. [Pg.281]

QA procedures - including auditing procedures and maintaining the master schedule... [Pg.53]

How does the QAU handle the Master Schedule (A schedule required by the government specifying each study by chemical, type, and dates of conduct.)... [Pg.78]

Many of you have expressed an interest in a format for your master schedule. Figure 1 depicts the format Mobay Chemical Corp. uses. It is self explanatory and covers the items required in the GLP regulations (test substance test system nature of study study initiation date current status sponsor identity, if explicable and name of study director). For a contract laboratory, the sponsor s identity must appear on the master schedule sheet for each study listed. There are several terms that require definition. In... [Pg.84]

When a protocol is issued, the study is put on the Master Schedule. The Master Schedule is a computer-generated document that can be formatted and sorted to accommodate the needs of various participants in the study as well as the Quality Assurance Section. It contains the protocol number, the trial numbers, the study title, the proposed start and finish dates of field and analytical segments of the study, the proposed reporting date, the names of field participants, the name of the study director, and other information that may be useful to the users of the master schedule. As a study... [Pg.101]

Is the master schedule adequate with contents (viz., test substance initiation date name of the sponsor study director name) ... [Pg.453]

The master schedule should include the following general activities. Further breakdown is not warranted at this time. [Pg.97]

Maintaining a copy of the master schedule sheet of all non-clinical laboratory studies, indexed by test article and containing the test system, nature of study, date study was initiated, current status of each study, identity of sponsor, and name of study director. [Pg.3066]

Other documentation targeted for storage in archives include the master schedule sheet, copies of protocols, and records of quality assurance inspections, summaries of training and experience, job descriptions, records and reports of the maintenance and calibration and inspection of equipment. In any case, ensure that the protocol or SOPs address the proper archiving of appropriate materials. [Pg.1274]

Are the master schedule sheet, copies of protocols, and records of QA inspections, as required by 58.35 maintained by the QAU as an easily accessible system of records for the period of time specified in (1) and (2) of this section ... [Pg.190]

Maintenance of the master schedule sheet (listing of all GLP projects in the facility). [Pg.227]

A study or studies that must comply with the GLPs have not been listed on the master schedule. [Pg.254]


See other pages where The Master Schedule is mentioned: [Pg.174]    [Pg.565]    [Pg.75]    [Pg.62]    [Pg.112]    [Pg.209]    [Pg.210]    [Pg.101]    [Pg.102]    [Pg.156]    [Pg.121]    [Pg.50]    [Pg.99]    [Pg.245]    [Pg.246]    [Pg.247]    [Pg.100]    [Pg.100]    [Pg.101]   


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Master schedule

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