Regulatory requirements in pharmaceutical manufacturing industry joymalya bhattacharya, m. A written record of major equipment cleaning, maintenance except routine maintenance such as lubrication and. The persons performing and doublechecking the cleaning and maintenance or, if the cleaning and maintenance is performed using automated equipment under 211. To lay down a procedure for maintaining of equipment log book.
A who guide to good manufacturing practice gmp requirements. The application is compliant with fda requirements for cfr title 21 including 21 cfr part 11 that outlines electronic records and signatures. Good manufacturing practice gmp, standard operating procedures sops. Hello, regarding the need to have gmp critical devices calibrated more frequently than gmp noncritical devices that cannot directly impact product quality, the quality manual good manufacturing practices. Corrections or modifications of data entry must not. The use of na and blank spaces learnaboutgmp community. 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. All purpose equipment maintenance log book for frequent. These documents provide the evidence that the raw materials, facility environment. These sop templates can be edited by you to cover your specific operations and practices, and will save you weeks of preparation time. This standard operating procedure is applicable for maintaining of equipment log book associated with product s. All entries on the workbooks and the specification and test reports must signed and dated. Procedure for instrument log books nc state university. Chapter 4 final 0910 european commission european union.
Northstar trailermounted hot water commercial pressure washer 4000 psi, 4. The rules governing medicinal products in the european union, eudralex volume 4 concise reference mindy j. We specialize in small quantities and quick turnaround at better pricing. This book is most often used to record equipment and facilities. Logbook, journal 102 pages, 5 x 8 inches unique logbooksrecord books logbooks, unique on. If equipment is dedicated to manufacturing one intermediate or api, then individual equipment records of different activities like. Comes complete with 110v pressurization pump with integral pressure control, pressure reducing valve and gauge, and translucent polyethylene solution.
Electronic equipment logbook opstrakker mobile app. Businesscritical consideration of images within the complex facilities, utilities, and equipment feu in a manufacturing plant, a line in. Electronic log book pharmaceutical logbook software amplelogic. The document control coordinator is responsible for ensuring the most recent version of the procedure is placed on the lan. Register logbook recording, in sequence, all production batches processed in the area. All products at log books unlimited are made with the utmost attention to. Save money and time by ordering your laboratory notebooks, log books, blank books, journals and madetoorder books factory direct from bookfactory.
This standard operating procedure is applicable for maintaining of equipment log book associated with product s manufactured at formulation plant. Creation and use of gmp equipment logbooks free gmp sop. By using a logbook, the awareness of the maintenance personnel for equipment breakdowns is heightened. Good laboratory practices glp part2 glp about gas chromatography, dissolution, atomic adsorption spectroscopy, titration, ph meter and conductivity meter. The basic rules in any good manufacturing practice gmp regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. Lab safety center logbook guidelines for laboratory safety coordinators tab responsible party chemical safety log book bio safety log book tab 1 p.
Gmp requires the maintenance of an equipment log showing historical status change events and genealogy. Cleaning method with details of who performed the cleaning. New employee training should include orientation topics. 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. Processes and requirements for equipment validation were created, and legal right of. Logbook definition of logbook by the free dictionary. Equipmentandutensils no sub inspectioncriteria yes no 10 areallbreweryutensilsandequipmentconstructedofadequatelycleanablematerialsandsuitablefortheirintended. 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. Equipment maintenance and operation log books unlimited. The maintenance of the equipment is given so much importance because it can ensure that the equipment can work properly for a longer. There is an online log book for each nmr spectrometer in the facility. Keep track of equipment maintenance with these hardcover log books.
All personnel should be aware of the principles of good manufacturing practice that affect. The control computer for each instrument has a shortcut icon on the desktop for accessing the applicable log book. 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. A who guide to good manufacturing practice gmp requirements part 1. If you start offline with an negative balance you lose morale and troops even thought you have enouth. Installation hardware requirements to run the application successfully, you need a pentium 200 mmx with windows 95, 32 mb memory and a sound. Equipment maintenance log is a sheet in which a user can easily input the details regarding the equipment of the store such as name, serial number, price, the date on which each item was brought and a lot more. Lab safety center logbook guidelines for laboratory safety. Manufacturing practice for finished pharmaceuticals subpart j records and reports section 211. The batch number should be immediately recorded in a logbook or by. Nautical terms a book containing the official record of trips. Good manufacturing practices gmp, but in addition, other gmp regulationsguide.
Usfda gmp inspection approach for facilities and equipment. Amplelogic electronic log book or elogbook software is a webbased solution helps to record and track the calibration logs, equipment usage, cleaning logs. Heidelberg perfecting technology provides technical innovations which combine to. Principle individual responsibilities should be clearly understood by the individuals and recorded. Responsibility all the concerned personnel shall be responsible to fo. Log books and laboratory notebooks factory direct from bookfactory, standard and madetoorder to your specifications. All companies are required to keep a logbook for the chronological documentation of equipmentrelated events such as validation and. Gmp electronic logbooks software free download gmp. The persons performing and doublechecking the cleaning and maintenance should date and sign or initial the log, indicating that the work was performed. Each sop template includes the procedure, one of more reporting. At gmp, we invest in the most efficient presses and leading edge technology in the printing industry. Gmp sop templates, gmp and iso 9001 compliance made easier. Sop on maintaining of equipment log book pharmaceutical.
They are storing offline earned gmp to your online account and drain your offline balance. Organization and peronnel gmp authorstream presentation. Register logbook recording, in sequence, all production. Phil management senior chemist, albert david limited. Opstrakker elogbook software is an electronic equipment use log designed specifically for fda gmp manufacturing facilities to help with equipment management. Provide detail all the starting materials, equipment and computerised systems if any. 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. Information that should be supplied in an equipment borrowers log are as follows.
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