By Donald C. Singer
Booklet by means of Singer, Donald C.
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Additional info for A Laboratory Quality Handbook of Best Practices & Relevant Regulations
This should be part of the regular internal audit program. Control and issuance of specifications, testing methods, and certificates of analysis must all be defined in SOPs. Only official, controlled copies of methods and specifications can be used. A suitable level of management must approve both documents, which clearly define the effective date. There must be adequate controls in place to ensure that only the new effective document is available and in use on the effective date. Equipment Logbooks Equipment logbooks should contain the complete history or at least the occurrence of the event of maintenance, calibration, and repairs.
Is it good practice? Emphatically, yes! It could save multiple problems and miscommunications at a later date. Until an incident occurs with the date format that has a significant impact (for example, delaying product shipment), then superficially there appears to be no problems with the dates. Photocopiers are an opportunity for a decimal point to be added or moved on the new copy and, without checking, could go undetected with potentially catastrophic consequences. 188. This section requires the checking of the master production record (directions for the manufacturing of a drug product) with the photocopy (the batch record) to ensure that it is an accurate reproduction of the original (master production record).
Backups are an integral part of the disaster recovery plan. Backups are stored in another location to thwart the loss of all data at one site. The off site storage conditions should be monitored to comply with storage for the raw data media being stored. Hardware The computerized or LIMS system hardware must be designed to insure raw data integrity, availability, and confidentiality. Documentation of the system configuration description should be developed and maintained. Hardware consists of computers, networks, storage devices, and peripheral devices including input and output devices.