Schedule master

The fundamental requirement of an efffective outage plan is well-defined work orders for each task that must be performed during the available time interval. Too many plants fail to fully plan each of the tasks that are to be performed. Instead, they rely on a master schedule that defines the sequence of events that must occur in order to complete all of the tasks included in the scope of work. 

Regular internal audits of GMP operations should be conducted according to an audit master schedule. Records of the findings and any follow-up actions should be maintained. Audits of key suppliers should also be conducted as part of a vendor qualification programme. 

A master schedule showing the sequence of implementing new technologies and process modifications... 

Test facility management Test site management Sponsor Study director Principal investigator Quality assurance program Standard operating procedures Master schedule... 

Study director means the individual responsible for the overall conduct of the study. Principle investigator means the individual who acts on behalf of the study director in case of multi site studies. Master schedule means a compilation of information to assist in the assessment of the workload and the tracking of studies at a test facility. 

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

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. 

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. 

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. 

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. 

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... 

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. ... 

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. 

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. 

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. 

To validate critical studies, such as long-term and reproduction toxicity studies, submitted to INDs or NDAs. These studies are selected at each center from master schedules collected in the course of previous GLP inspections or from reviews prepared by the pharmacologist responsible for evaluating applications for research and marketing permits. 

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. 

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. 

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. 

Maintenance of an independent quality assurance unit within the laboratory to be responsible for a master schedule, sample receipt, and periodic inspections of the conduct and reporting of each laboratory study. 

QA procedures - including auditing procedures and maintaining the master schedule... 

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

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... 

Master schedule format (Reproduced with permission from Mobay Chemical Co.). 

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... 

Records are kept of when a sample was collected, the method of collection, who collected the sample, what the elapsed time was between harvest and freezing, the conditions under which it was stored, how it was shipped to the laboratory, and when it was shipped. When a sample arrives at the laboratory, the condition of the sample is checked and recorded. Then the information on the sample bag (sample number, application rate, preharvest interval, etc.) is compared to the trial information sheets which are submitted along with the samples. Any omissions or discrepancies are corrected at that time. If there is an omission or discrepancy that cannot be easily corrected by a telephone call from the sample processing laboratory to the field scientist, the study director is notified. The study director must make the decision about the validity of the sample and put a note in the data file explaining how the problem was corrected or that the problem could not be corrected and the trial is to be abandoned. If the trial is dropped, Quality Assurance is notified, the trial is deleted from the active Master Schedule, and an explanation is put in the study file. 

I am not going to go into the more obvious quality assurance program requirements that are applicable to all laboratories. These general requirements include the provision for a Quality Assurance Unit, the availability of a qualified staff, the presence of facilities and equipment adequate to permit the type and number of studies being performed, a master schedule of ongoing and completed studies, storage areas for active and used samples, and archives for the retention of reports and raw data. 

Quality Assurance Unit—independence, master schedule, audits, and inspections... 

The facility should ensure the maintenance of a master schedule. 

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