Bpn product description inprocess finished goods or final packed product code no. Documentation helps to build up a detailed picture of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a basis for planning what it is. Owen the objective of good laboratory practice glp is to obtain accurate. Volume 4 of the rules governing medicinal products in the european union contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products. Good laboratory practice with a uvvisible spectroscopy. Good laboratory practices, good clinical practices, and good manufacturing practices. Guide to fda approval process and importance of equipment. These include factories, science research labs, and workshops among many others. Practical approaches to ensure that analytical methods and instruments meet gmp standards and requirements. Preventive maintenance strategies for the pharmaceutical. All companies are required to keep a logbook for the chronological documentation of equipmentrelated events such as validation and qualification work, calibration, equipment cleaning, preventive maintenance and repairs and unexpected eventsdeviations for manufacturing equipment, apparatus, quality control and ipc analytical equipment and utilities. Good practice gxp regulations require an instrument maintenance and use log. Table i lists the glp and gmp requirements for an instrument maintenance and use log.
Sop on maintaining of equipment log book pharmaceutical. Usfda gmp inspection approach for facilities and equipment. All companies are required to keep a logbook for the chronological documentation of equipmentrelated events such as validation and. Electronic log book elogs for the pharmaceutical industry. Manual of food safety management system, fss act 2006 ranjan saha. The basic rules in any good manufacturing practice gmp regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. The authority to delete files and override computer systems. Titrator annexure and note down the instrument id in protocols of analysis. Many types of log management programs can be created and managed in valgenesis elog, including equipment logs and clean room logs, etc. How to implement good documentation practices pharmout pty ltd, abn. Creation and use of gmp equipment logbooks free gmp sop. Prior to removing an instrument from service, a final calibration shall be performed, if possible i. Complete instrument history the instrument system log book is an integral part of the iqoq program as it ensures a.
Equipment records page 1 of 6 sections in this document. An equipment maintenance log helps in keeping a record for this procedure. The application is compliant with fda requirements for cfr title 21 including 21 cfr part 11 that outlines electronic records and signatures. The facilities system elements examine the general. Logbooks required are determined by gmp requirements for the traceability of data, events, and communications. Amplelogic electronic log book is a webbased software or platform that records general production requirements and tracks down area and. If you need another practice chart or log, click below to print another copy. A laboratory log book is a tamper proof record of laboratory activities related to use of testing equipments, environmental conditions in laboratory and. This record, in turn, holds significance for various organizations where different types of apparatus, appliances or articles are. Maintaining an equipment logbook is a mandatory requirements as per fda. Within maintenance, preventive maintenance pm is a substantial portion of the. The calibration logbook should also be used when a technician takes the instrument out of service for repairs or training purposes.
If this is the case, print a new log sheet and replace the completed one with the new one. Register logbook recording, in sequence, all production. All the concerned personnel shall be responsible to follow the procedure for maintaining of equipment log book. Who defines good manufacturing practices gmp as that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their. Documentation and records, good manufacturing practices, quality assurance. If the fda inspections identify deviations from the regulations, they will issue inspectional observations using. This standard operating procedure is applicable for maintaining of equipment log book associated with product s manufactured at formulation plant. An electronic equipment logbook app ipad android pc that replaces paper based equipment use logs eul in fda regulated gmp manufacturing facilities. Ensure that instrument is clean and free from dust.
When a new dry gas tank is received, the technician should record the. To lay down a procedure for maintaining of equipment log book. Electronic log book pharmaceutical logbook software amplelogic. Procedure for instrument log books nc state university.
For problems with instruments, please list the symptoms. The instrument or equipment records are compiled and required information maintained in a readily accessible manner. This standard operating procedure is applicable for maintaining of equipment log book associated with product s. The batch number should be immediately recorded in a logbook or by. The instrument specification record shall be attached to the instrument change record form. Opstrakker elogbook software is an electronic equipment use log designed specifically for fda gmp manufacturing facilities to help with equipment management. Installation qualification and operation qualification iqoq.
Users can capture logs through mobile devices by simply scanning the qr code available at the equipment, instruments andor clean rooms, with or without. Equipment qualification for laboratory balances and. Good manufacturing practices gmp are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of. Gmp guitars strives to produce the highest quality custom instruments on the market today.
An instrument log book should be employed to document these procedures over time. Periodic general maintenance of the hplc is one type of service procedure which should be. Complementing the authors first book, analytical method validation and instrument. Good manufacturing practice regulations require an active training program and the documented evaluation of the training of analysts.
Electronic equipment logbook opstrakker mobile app. This record, in turn, holds significance for various organizations where different types of apparatus, appliances or articles are used. Analyze the full log sheet to see whether maintenance is needed in the near future. Amplelogic electronic log book or elogbook software is a webbased solution. It is a diverse community of more than 9,000 professionals united by one important. Have spectroscopy laboratories and software suppliers. Good laboratory practice with a uvvisible spectroscopy system application note uvvisible spectroscopy anthony j. Instrument system log book ensures a complete record of activities is maintained.
Importance of maintaining laboratory log books lab. All companies are required to keep a logbook for the chronological documentation of equipmentrelated events such as validation and qualification work, calibration, equipment cleaning, preventive. Calibration logbook record calibration results alcopro. Practical approaches to method validation and essential. Gamp, good manufacturing practice gmp, standard operating procedures.