Label control program

The label control program and procedure includes labeling requirements. The program is structured to ensure the following  

A system for determining the day-to-day status of critical systems, areas, and activities will be developed. Activities such as batch production, cleaning, preventive maintenance, calibration, load sterilization, etc. will be controlled and documented by procedure in logbooks and reviewed and filed as critical processing documentation. 

Status tags will be utilized to indicate the status, such as under cleaning, clean, in-process, quarantine, released, etc. Procedures will be developed for the placement and removal of status tags. 

A checklist will be developed to establish proper room clearance prior to initiating a production batch. Checklist development, handling, control, and review will be incorporated into procedures for ongoing control. 

A program to ensure control of critical system documentation will be established. The files will be controlled by QA. Validation and centralized for easy retrieval. Equipment validation data such as operating and service manuals, purchase orders, manufacturer specifications, as-built drawings and schematics, spare parts lists, and any other information pertaining to the system will be included in the file. Separate validation files for Facility, Systems, and Process validation of each product, including all related data, will be maintained. Procedures will be developed to create files for new equipment, update information for existing equipment, control, removal, and return of information, etc. 

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Sample management and sample plans Stability program Packaging and labeling Labeling controls and approvals Package development... 

WebLab Viewer gives a very-high-quality display suitable for publication and presentation. Molecules can be displayed as lines, sticks, ball and stick, CPK, and polyhedrons. In addition, different atoms within the same structure may be displayed in different ways. Text can be added to the display as well as labeling parts of the structure in a variety of ways. The user has control over colors, radii, and display quality. The program can also replicate a unit cell to display a crystal structure. Several types of molecular surfaces can be displayed. 

A well planned public health program is needed for the safe exploitation of agricultural chemicals. This should embody research on toxicity, cooperation of public and private agencies for exchange of information and promulgation of control measures, labeling of economic poisons, adequate inspection, and education in occupational and consumer health. 

FDA device regulation is focused on the device and the device manufacturer. CLIA, on the other hand, focuses on laboratory quality, including the quality of the laboratory test results provided by the devices used, whether developed in-house or as a test kit in commercial distribution to multiple laboratories. The programs differ substantially in approaches and in data requirements. FDA requires unique submissions for each test under its purview, evaluates both performance and labeling, and requires demonstration of analytical validity and clinical validity as appropriate. CLIA inspects laboratories using a system approach based on key probes of the operating system. CLIA requires a demonstration of analytical performance and quality control but does not require a showing of either clinical validity or clinical utility. 

As of the date of this chapter (circa March, 2002), labeling changes regarding pediatric use have resulted from only two programs—the study of buspirone in pediatric GAD and a pharmacokinetic study of fluvoxamine in pediatric OCD (fluvoxamine already had a controlled clinical trial in pediatric patients). Two placebo-controlled trials with buspirone in pediatric GAD did not reveal a treatment effect, and this negative outcome is reflected in Buspar labeling. A pharmacokinetic study of fluvoxamine dosed at 100 mg bid in pediatric... 

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