Corrections or modifications of data entry must not. The persons performing and doublechecking the cleaning and maintenance or, if the cleaning and maintenance is performed using automated equipment under 211. All personnel should be aware of the principles of good manufacturing practice that affect. A written record of major equipment cleaning, maintenance except routine maintenance such as lubrication and. Equipment log book 96 total pages 5 x 7, your choice of cover color and titles log09657eleq hardback your choice of cover color imitation leather cover with coating for durability in lab. This standard operating procedure is applicable for maintaining of equipment log book associated with product s manufactured at formulation plant. All purpose equipment maintenance log book for frequent. Good manufacturing practice gmp, standard operating procedures sops. If equipment is dedicated to manufacturing one intermediate or api, then individual equipment records of different activities like. This includes cookies that are technically necessary for the proper operation of the site, as well as cookies that are used for statistical purposes, for comfort settings or to display.
Logbook, journal 102 pages, 5 x 8 inches unique logbooksrecord books logbooks, unique on. Procedure for instrument log books nc state university. Principle individual responsibilities should be clearly understood by the individuals and recorded. Electronic equipment logbook opstrakker mobile app. Manufacturing practice for finished pharmaceuticals subpart j records and reports section 211.
Information that should be supplied in an equipment borrowers log are as follows. The persons performing and doublechecking the cleaning and maintenance should date and sign or initial the log, indicating that the work was performed. Cleaning method with details of who performed the cleaning. The maintenance of the equipment is given so much importance because it can ensure that the equipment can work properly for a longer. Chapter 4 final 0910 european commission european union. The application is compliant with fda requirements for cfr title 21 including 21 cfr part 11 that outlines electronic records and signatures. The batch number should be immediately recorded in a logbook or by. We specialize in small quantities and quick turnaround at better pricing. All products at log books unlimited are made with the utmost attention to. Responsibility all the concerned personnel shall be responsible to fo. Equipmentandutensils no sub inspectioncriteria yes no 10 areallbreweryutensilsandequipmentconstructedofadequatelycleanablematerialsandsuitablefortheirintended. The basic rules in any good manufacturing practice gmp regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. The rules governing medicinal products in the european union, eudralex volume 4 concise reference mindy j.
An electronic equipment logbook app ipad android pc that replaces paper based equipment use logs eul in fda regulated gmp manufacturing facilities. Electronic log book pharmaceutical logbook software amplelogic. Usfda gmp inspection approach for facilities and equipment. Good laboratory practices glp part2 glp about gas chromatography, dissolution, atomic adsorption spectroscopy, titration, ph meter and conductivity meter. Entries in the log should be in chronological order. Creation and use of gmp equipment logbooks free sop 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 mai. Gmp requires the maintenance of an equipment log showing historical status change events and genealogy. By using a logbook, the awareness of the maintenance personnel for equipment breakdowns is heightened. The use of na and blank spaces learnaboutgmp community. Comes complete with 110v pressurization pump with integral pressure control, pressure reducing valve and gauge, and translucent polyethylene solution. Opstrakker elogbook software is an electronic equipment use log designed specifically for fda gmp manufacturing facilities to help with equipment management.
Nautical terms a book containing the official record of trips. New employee training should include orientation topics. Provide detail all the starting materials, equipment and computerised systems if any. The document control coordinator is responsible for ensuring the most recent version of the procedure is placed on the lan. Equipment maintenance and operation log books unlimited. Northstar trailermounted hot water commercial pressure washer 4000 psi, 4. Businesscritical consideration of images within the complex facilities, utilities, and equipment feu in a manufacturing plant, a line in. The fda conducts these audits in accordance with the guidance provided by ich q7a. Lab safety center logbook guidelines for laboratory safety coordinators tab responsible party chemical safety log book bio safety log book tab 1 p. All entries on the workbooks and the specification and test reports must signed and dated. Good manufacturing practices gmp, but in addition, other gmp regulationsguide. At gmp, we invest in the most efficient presses and leading edge technology in the printing industry. A who guide to good manufacturing practice gmp requirements part 1.
Organization and peronnel gmp authorstream presentation. It is very important for a department to have an equipment borrowers log so that they can record all the equipment that are being borrowed by other employees from a different department. This standard operating procedure is applicable for maintaining of equipment log book associated with product s. A who guide to good manufacturing practice gmp requirements. All companies are required to keep a logbook for the chronological documentation of equipmentrelated events such as validation and. Each sop template includes the procedure, one of more reporting. Creation and use of gmp equipment logbooks free gmp sop. This manual describes how to install and use the gnu multiple precision arithmetic library, version 6. These sop templates can be edited by you to cover your specific operations and practices, and will save you weeks of preparation time. If you start offline with an negative balance you lose morale and troops even thought you have enouth. Keep track of equipment maintenance with these hardcover log books. Managing complex equipment status in a gmp environment. Regulatory requirements in pharmaceutical manufacturing industry joymalya bhattacharya, m.
The logbook is to be ruled up according to the template set out in point 4. Heidelberg perfecting technology provides technical innovations which combine to. Lab safety center logbook guidelines for laboratory safety. Log books and laboratory notebooks factory direct from bookfactory, standard and madetoorder to your specifications. Gmp sop templates, gmp and iso 9001 compliance made easier. I just wanted to get some feed back from other professional across the globe on how they currently handle extra blank spaces whether in protocols or other pharama documentation. The control computer for each instrument has a shortcut icon on the desktop for accessing the applicable log book. Sop on maintaining of equipment log book pharmaceutical. Logbook definition of logbook by the free dictionary.
Register logbook recording, in sequence, all production. Register logbook recording, in sequence, all production batches processed in the area. There is an online log book for each nmr spectrometer in the facility. A written record of major equipment cleaning, maintenance except routine maintenance such as lubrication and adjustments. To lay down a procedure for maintaining of equipment log book. This book is most often used to record equipment and facilities. Gmp electronic logbooks software free download gmp. Standard operating procedure title laboratory workbook. Logbooks required are determined by gmp requirements for the traceability of data, events, and communications. Processes and requirements for equipment validation were created, and legal right of.
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