What is an equipment logbook?
An equipment maintenance log is a document that organizations use to record asset maintenance activities. It enables them to monitor their system checkup processes and track maintenance tasks performed by technicians, the exact time the tasks were performed, and each specific task’s purpose.
What is pharma logbook?
All companies are required to keep a logbook for the chronological documentation of equipment-related events such as validation and qualification work, calibration, equipment cleaning, preventive maintenance and repairs and unexpected events/deviations for manufacturing equipment, apparatus, quality control and IPC …
What is documentation in pharmaceutical industry?
Documentations are to define the manufacturers system of information & control, to minimize the risk of misinterpretation & errors inherent in oral or casually written communication, to provide unambiguous procedures to be followed to provide confirmation of performance, to allow calculations to be checked & to allow …
What is cGMP documentation?
Specifications & SOPs SOPs maintain cGMP documentation, which are written guidelines that explain each step of the production process. The purpose is to ensure that employees complete every step of an operation in a consistent manner, in a controlled environment, and with quality standards guiding their intended use.
What are equipment records?
Equipment Records means those maintenance and other records relating to the Equipment in the possession of the Lessee. Equipment Records means all records, logs, and other documents related to the Lessee’s operation and maintenance of the Equipment.
What for equipment records are created?
The Equipment Record shows you all equipment information and gives you options to manage your equipment. The form is shown in the following figure, and consists of the following: Status Section: The status sections shows the Equipment State of the current Equipment Record.
What is SOP and GMP?
Standard Operating Procedures (SOPs) are issued to specifically instruct employees in areas of responsibility, Work Instructions, appropriate specifications and required records. SOPs outline procedures, which must be followed to claim compliance with GMP principles or other Statutory rules and regulations.
What is the GMP requirements for documentation?
GMP requires that documents have the following control features:
- Unique number.
- Version number.
- Date of introduction.
- Date of review (or expiry)
- Signatures of at least the qualify unit and the author or subject matter expert.
- A reference to previous document history.
Why do you required to record the equipment details?
Documenting every repair or maintenance work done on your equipment will help you process warranty claims much easier. Keep a record of the type of maintenance work done to your equipment as well as the exact time and date repairs were done as this information will help determine your rights for the warranty claims.
What is equipment record?
Why do pharma companies need to keep logbooks?
All the pharma manufacturing companies are required to keep logbooks in place for documentation of usage logs of equipments, calibration, preventive maintenance, environmental conditions, cleaning, repairs, quality control logs, stability logs and other major equipment logs and needs to comply with Good Manufacturing Practices (GMP) regulations.
What is equipment usage logbook?
What is Equipment usage logbook : The purpose of this Document is for Recording the usage, cleaning and maintenance activity of Equipment in a chronological order, with done by, checked and reviewed by signature. Separate Equipment usage log shall be issued for each process Equipment and Issued Equipment usage log book shall be used for execution.
What is the procedure for maintaining machine use log?
To lay down the procedure for maintaining machine use log. This SOP shall be applicable for maintaining machine use log of all production equipments in tablet and capsule manufacturing and packing areas. 5.1 Write activities carried out for particular equipment in the logbook assigned for that equipment in format on daily basis.
What is the procedure for log book in quality control?
After receiving of samples in QC concerned person shall enter all the details in respective log book. Keep all blank (unused) and filled log books into lock and key. Maintain the track record of issued and closing of log book in Quality Control.