Equipment logbooks

Documentation requirements are predicated on the types of batches to be manufactured at the pilot facility. For the development of novel formulations, laboratory notebooks are the primary source of documentation. Room and equipment logbooks should be maintained. Personnel training records and SOPs must also be maintained. Once the facility is used for the larger-scale batches described earlier, what was recommended now becomes required. Manufacturing runs need to be documented accurately, preferably in batch records. Logbooks should maintain an accurate record of the product history in rooms and equipment. At this level of manufacturing, it is also important that personnel training records be kept. These... 

Printouts for in-process checks Weight tickets Cleaning status tags Transport tickets for mobile equipment Campaigned equipment logbook Laboratory slips and worksheets... 

Equipment logbooks, status tags, and room clearance Validation files Drawings/Layouts... 

Issuing and maintenance of an equipment logbook to document relevant... 

Maintenance procedures should be distinguished as routine or nonroutine. In the event of a nonroutine operation, the record should indicate the nature of the failure, how and when it was discovered and any remedial action taken in response to the failure. All records must contain the date of maintenance and the initials of the person performing the procedure. A record of all routine and nonroutine maintenance should be maintained for each piece of equipment or system, e.g. LC-MS/MS with autoinjector, in the laboratory. An instrument maintenance logbook should be maintained for each mass spectrometer system and be readily available. In addition to any requirements in the laboratory s SOPs, the following information shonld be inclnded in the equipment logbook the equipment identification, model number, serial number, the date the equipment was put into service, current location, reference(s) to any relevant SOP(s) and contact information for the equipment manufacturer and/or service organization. 

It should be decided if levels of protection need to be adjusted or if other appropriate action should be taken. All readings taken should be recorded in a logbook and become part of the site permanent record and project file. Reading results of 0 or nondetect should be recorded. After all, when it comes to screening equipment from the safety and health point of view, 0 is a very important number. 

Storage chambers should be validated with respect to their ability to maintain the desired conditions, and, if so equipped, the ability to sound an alarm if a mechanical or electrical failure causes the temperature to deviate from preestabilished limits. They should also be equipped with recording devices, which will provide a continuous and permanent history of their operation. Logbooks should be maintained and frequent readings or mercury-in-glass, National Institute of Science and Technology traceable thermometers recorded. 

Maintain the logbook for the equipment used in this experiment, recording your name(s), the date, and the experiment number and name. 

Materials, processes, and control parameters for drug production are stated in written documents. Production personnel follow procedures and record materials used, amounts weighed, and date of operation. Equipment, reaction vessels, and the production area are cleaned and their status recorded in logbooks. Throughout the production stages, equipment conditions (e.g., pH, pressure, stirring speed, and temperature) are also recorded. Adjustments to in-process control parameters, if permitted, are entered onto batch records. 

Equipment inspection, maintenance, and repair records can be recorded in a logbook especially designed for that purpose. For equipment that is moved from laboratory to laboratory, the logbook should accompany the equipment when it is moved. Documentation of calibrating or standardizing operations, on the other hand, may be more efficiently recorded with the associated records of the data acquisition activities. 

Development of a logbook system. Logbooks are another QA vehicle that complements the PV effort. They are used to document any activity that involves the equipment they cover (e.g., cleaning or maintenance). 

Logbooks are typically used to document ancillary cleaning activities and equipment usage. These logbook entries must consistently correspond to the activities delineated in any given batch record. 

An electronic or bound paper logbook should be prepared for each instrument in which operators and service technicians record aU equipment-related activities in chronological order. Information in the logbook can include the following ... 

All maintenance activities should be recorded in a maintenance logbook. To make this more convenient, modem equipment includes electronic maintenance logbooks where the user enters the type of maintenance, and the equipment records this activity together with the date and time. 

Pharmaceutical products for clinical trials and market supply are manufactured in a multipurpose building. The building is equipped with a flexible HVAC system that allows individual clean room parameter settings for separate rooms. These parameters are set by the employees and documented in a traditional paper logbook Question... 

The manufacturer s specifications, past experience, and history of the equipment will be used to establish the preventive maintenance schedule. Procedures will be developed for issuing work orders, performing the maintenance work, documenting the work in the proper logbooks and hies, frequency of performing preventive maintenance, reviewing the impact of maintenance on validation state, etc. 

Logbooks should be kept with major and critical equipment and should record, as appropriate, any validations, calibrations, maintenance, deanmg, or repair operations, induding dates and the identity of the people who carried these operations out... 

OSHA has established a six-step procedure for locking out a piece of equipment. All of this information involved in the steps should be recorded in a lockout logbook. 

All equipment binders/logbooks are checked for good condition and maintained up to date. 

For integrated systems that are comprised of different pieces and types of equipment, the configuration of the system at any given time should be documented in the equipment maintenance logbook for the main system component. This procedure allows individual pieces of equipment to be exchanged as needed but preserves the ability for a reviewer to determine how the system was configured on any given date. This procedure also allows the laboratory to keep a complete maintenance... 

Logbooks (see Sect. 33.7) a logbook describes chronologically the history of equipment or premises, such as operatimi during use, maintenance, update, renewal and repair. 

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