Big Chemical Encyclopedia

Chemical substances, components, reactions, process design ...

Articles Figures Tables About

Records maintenance, responsibility

Ensure that prospective employees are qualified to inspect, repair, and maintain the carrier s vehicles by queiying applicants, checking with previous employers and references, and obtaining necessary documents regarding inspection, repair, and maintenance responsibilities and (for mechanics and technicians) the quality of previous work, including whether maintenance services were systematic and well documented. Create a detailed written record of each inquiry. [Pg.284]

The prerequisite for proper planning and performance of building maintenance is the comprehensive set of drawings, specifications and servicing manuals compiled by architects, engineers, contractors and suppliers, respectively. Those responsible for maintenance must ensure that all records are kept up to date computers are increasingly used for this purpose. [Pg.57]

All drivers are responsible for refueling their vehicles at the end of each shift. All other routine maintenance should be performed by maintenance-department personnel, who are also responsible for maintaining service records. If a driver believes a vehicle is in need of mechanical repair, the driver should fill out the pink repair requisition form and give it to the shift supervisor. The driver should also notify the shift supervisor verbally whether, in the driver s opinion, the vehicle must be repaired immediately or may be driven until the end of the shift. [Pg.148]

There should be specific responsibility assigned for the maintenance of historical records. Issues of importance, which should be addressed by the management system, include specifying who will keep the records, where and how they will be maintained, and how they can be retrieved and used at both the facility and company-wide levels. In addition, there should be adequate consideration for backing up critical records and protecting the records against loss. [Pg.117]

Organization and personnel describe that in the dispensing of all prescriptions, the pharmacist has the responsibility and authority to inspect and approve or reject all components, drug product containers, closures, in-process materials, and labeling. It also has the authority to prepare and review all compounding records to assure that no errors have occurred in the compounding process. The pharmacist is also responsible for fhe proper maintenance, cleanliness, and use of all equipmenf used in prescription compmmding practice. [Pg.396]

When appropriate means that a laboratory only need specify remedial action in response to equipment failure or malfunction when remedial action is appropriate to the piece of equipment. A laboratory may elect to discard rather than repair faulty equipment however, records for the discarded equipment, including records of previous maintenance and calibration, must be retained for the length of time described in 58.195(b) and (f). [Pg.76]

Records of routine maintenance operations may reference the SOPs for a description of the operations. For nonroutine repairs in response to equipment failure or malfimction, repair records must contain the following detailed information nature of the defect, how the defect was discovered, when the defect was discovered, and remedial action taken in response to the defect. Remedial action should include a review of possible effects on data generated before the defect was discovered. Because repairs are likely to involve repeur-men from outside the laboratory, care must be taken to ensure that such persons provide fuU documentation of the nature of the problem and remedial action taken in response to the problem. [Pg.77]

Workshops on operational responsibilities, record keeping, good housekeeping practice, and routine maintenance of the cooling tower and related equipment to minimize microbial growth. [Pg.321]

A fundamental objective of a computer system applied to automate a pharmaceutical GMP operation is to ensure the quality attributes of the drug product are upheld throughout the manufacturing process. It is therefore important that quality-critical parameters are determined and approved early in the validation life cycle. The exercise should be undertaken to a written procedure with base information from the master product/production record file examined and quality-critical parameter values and limits documented and approved for the process and its operation. In addition, the process and instrument diagrams (P IDs) should be reviewed to confirm the measurement and control components that have a direct impact on the quality-critical parameters and data. This exercise should be carried out by an assessment team made up of user representatives with detailed knowledge of both the computer system application and process, and with responsibility for product quality, system operational use, maintenance, and project implementation. This exercise may be conducted as part of an initial hazard and operability study (HAZOP) and needs to confirm the quality-related critical parameters for use in (or referenced by) the computer control system URS. [Pg.578]

Note Procedural controls for computer applications may include development, use, and support of systems, data handling, storage and retrieval, maintenance, repair, calibration of equipment, management and personnel responsibilities, record retention, training. [Pg.256]

In relationship to new product development, R D has a key role in the formation of the batch record. Without proper documentation maintenance at an early state of development, transferring the process from development to operations will be problematic at best. Development personnel should be cognizant of all the information needed by production operators responsible for scale-up and/or technology transfer. Consider the following ... [Pg.306]


See other pages where Records maintenance, responsibility is mentioned: [Pg.153]    [Pg.417]    [Pg.417]    [Pg.153]    [Pg.153]    [Pg.545]    [Pg.443]    [Pg.730]    [Pg.828]    [Pg.562]    [Pg.1040]    [Pg.1043]    [Pg.62]    [Pg.958]    [Pg.88]    [Pg.137]    [Pg.48]    [Pg.490]    [Pg.63]    [Pg.182]    [Pg.66]    [Pg.76]    [Pg.66]    [Pg.120]    [Pg.314]    [Pg.197]    [Pg.365]    [Pg.45]    [Pg.633]    [Pg.47]    [Pg.41]    [Pg.45]    [Pg.255]    [Pg.88]    [Pg.134]   
See also in sourсe #XX -- [ Pg.97 ]




SEARCH



Records maintenance

© 2024 chempedia.info