Master schedule sheet

Maintain a copy of a master schedule sheet of all (nonclinical laboratory) studies conducted at the testing facility. 

Maintain a copy of a master schedule sheet of all nonclinical laboratory studies conducted at the testing facility indexed by test article and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director. 

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. 

In preparing for a routine inspection, it is necessary to select toxicology studies for audit that are as representative as possible of the laboratory s current operations. This is done either by the assigning center s GLP unit prior to the inspection or by the field investigator at the laboratory site. When made by the field investigator, the selection is drawn from the firm s GLP master schedule sheet. 

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. 

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... 

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. 

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 ... 

Maintenance of the master schedule sheet (listing of all GLP projects in the facility). 

QAU Master Schedule Sheet Study Inspections QA Auditing Procedure Draft and Final Report Audits Archives... 

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