Equipment maintenance and calibration sop

To lay down the procedure for operation, calibration, cleaning and maintenance of bod incubator. Cleanup and regular maintenance is important for keeping equipment in good working order. Equipment planner shall contain information like equipment name, equipment id, location, calibration date next calibration due date and signatures. Sop on calibration management in pharmaceutical industry. Objective to lay down the procedure for operation, calibration, cleaning and maintenance of laf. Meeting the criteria in this procedure demonstrates control of the maintenance and calibration parameters needed to. Standard operating procedure of preventive maintenance and checklist of all equipment and systems as per their frequencies in pharmaceutical industries. Procedure for equipment calibration and maintenance. Maintenance procedure an overview sciencedirect topics. Staff shall keep specific maintenance logs for all equipment used.

Preventive maintenance pm procedure gmp sop standard. The purpose of this sop standard operating procedure is to describe the procedure for the calibration schedule and calibration practices of instrument equipment. To lay down the procedure for preventive maintenance. A better way is to use a riskbased approach that classifies each piece of. To outline the methods and frequency of evaluating and maintaining equipment used in animal facilities. The equipment or instrumentation is purchased using the following criteria. Assure all equipment in the kitchen area is well maintained. Maintenance history should be used to support maintenance activities, upgrade maintenance programmes, optimize equipment performance and improve equipment reliability. Appropriate arrangements should be made for orderly collection and analysis of records and production of reports on maintenance activities.

The purpose of this standard operating procedure sop is to describe the procedures involved in commissioning, conducting and managing a sites. Wellmaintained lab equipment ensures that data is consistent and reliable, which in turn impacts the productivity and integrity of the work produced. Ensures equipment is properly maintained according to established criteria. Providence rd, suite 1050, media, pa 19063, usa summary writing standard operating procedures sops for laboratory equipment is viewed as a.

A protocol, on the other hand, is a studyspecific document that describes how a process is carried out within a single study. Each operator is responsible for proper handling and maintenance of equipment under use in order to maintain the continued accuracy of the equipment. Package consists of the procedure, a calibration and preventive maintenance report, a new equipment form, a master. Sop on operation, calibration, cleaning and maintenance of. Such equipment must have records of calibration andor preventative maintenance. In this sop, term equipment shall be commonly used for all machines, instruments and equipments installed in all departments. This sop shall be applicable for preventive maintenance of all types of equipment and systems. This sop is applicable for operation, calibration, cleaning and maintenance of bod incubator in microbiology laboratory at pharmaceutical formulation plant. The preventive maintenance program was and still is a focal point of gmp inspection.

Fill calibration containers with the buffered standards so each standard will cover the ph probe and temperature sensor. Measurement and test equipment are those devices used to test, measure, evaluate, inspect, or otherwise examine materials, supplies, equipment, and systems, or to determine compliance with specifications. Scope this sop is applicable for operation, calibration, cleaning and maintenance of laf in microbiology laboratory of pharmaceutical company name. Sop templates and sop on sops irina colligon1, and michelle rosa2 1downingtown, pa, usa 2bethlehem, pa, usa summary document templates are valuable tools and standard operating procedure sop templates are no exception.

As per cgmp requirements, schedules of preventive maintenance for each equipment in the facility should be prepared, monitored and documented. Calibration programs required by regulatory authorities. Manual 060 maintenance and calibration of gmp critical item. Maintenance standing operating procedures 43 appendix d desk reference manuals 45. This is updated to record any new equipment added and also items withdrawn from service or subject to limitation due to condition. Equipment that is considered not in need of calibration will also be recorded on this list. The analyst shall follow the procedure of the respective instrumentequipment sop for the calibration.

To ensure that equipment used in animal facilities for the generation. Having a program in place ensures that the process is under control and that biological, chemical and physical hazards are. Region 1 calibration of field instruments revision number. Equipment calibration and maintenance sopecm02 ensuring that if research equipment calibration and maintenance is the responsibility of another partygroup i. Equipment and utensils part d cgmp sop templates and. Equipment maintenance and calibration province of manitoba.

The primary goal of an equipment management program is to ultimately decrease the amount of unscheduled equipment maintenance by increasing the efficiency in managing the scheduled equipment maintenance. This form such can be used to record regularlyscheduled routine maintenance. Maintenance of laboratory equipment it is intended to. Sop for calibration of instruments in production and. In case of any breakdown or additional calibration due to replacement of any part or maintenance, qc executive or designee shall issue the calibration format of instrumentequipment. Ph40 calibration and preventive maintenance sop template. It includes sample document formats, calibration labels layouts and details the importance of the post calibration report. Procedure for calibration of instruments equipments. This sample calibration procedure defines the calibration program requirements for all measurement and test equipment mte. Calibration shall be done using certified calibration standards traceable to nationalnist standards either inhouse or from a certified outside agency. An overview michelle rosa parexel consulting, a division of parexel international 1400 n. If a study has special requirements for maintenance or calibration of equipment, these should be described in the protocol. Equipments in routine use shall be maintained through intermittent calibration, preventive maintenance program and revalidation procedure. With the exception of items modified and clarified in this sop, follow.

Glp sops for equipment calibration and maintenance. Remove probe from its storage container, rinse with deionized water, and remove excess water. Ich q7 guidelines schedules and procedures should be established for the preventive maintenance of equipment. Calibration methods and frequency noted in sops relevant to the equipment or instrumentation. Kitchen sop equipment handling, sop equipment cleaning hotel kitchen, sop kitchen equipment sanitising. Laboratory equipment care and maintenance conduct science. Equipment which requires calibration shall not be used if satisfactory calibration cannot be achieved or the calibration date has passed. Sop for preventive maintenance of production equipment. Agencies have realised that the preventive maintenance program is a crucial component of any modern quality system because it ensures efficient gmp operations. A safety guard or mechanism shall be in place over the can crusher opening to prevent staff injury.

Calibration and preventative maintenance procedures. The true value of the sop on sops is often underestimated. This sop is applicable to the calibration of instrument equipment maintained by the quality control department in the pharmaceutical product manufacturing plant. Operation and calibration of ph meter pharma beginners. Standard operating procedure equipment calibration and. An sop is a document that outlines a standard project or studyindependent process. Sop for preventive maintenance of equipments and systems. Customize these sop templates and supporting documents to comply with cgmp requirements for equipment and utensils login. The equipment in need of calibration will be annotated b. The state of louisiana is committed to a continuing, aggressive program for maintenance of boiler and machinery equipment, and all other equipment.

Environmental conditions required for the equipment. Its common to treat every piece of equipment within a pharma plant equally when it comes to maintenance. Calibration sop of respective instrumentequipment shall mention the calibration schedule and acceptance criteria. The care and maintenance of laboratory equipment is an integral part of quality assurance in the lab. A comparison of two instruments or measuring devices one of which is a standard of known accuracy traceable to national standards to detect, correlate, report or eliminate by adjustment, any discrepancy in accuracy of the instrument measuring device being compared to the standard. Calibration and maintenance procedure sop there should be a documented sop for conducting the calibration and preventive maintenance for each type of instrumentation. Specific calibration, performance check, andor preventative maintenance programs and procedures for critical equipment are found in the quality assurancequality control procedures manual. This sop lists, details and defines each of the 11 essential elements of cgmp compliant calibration and calibration management. The purpose of this sop standard operating procedure is to describe the procedure of operation, standardization, and maintenance of ph meter.

Joint united kingdom uk blood transfusion and tissue transplantation services professional advisory committee. Standard operating procedure sop for operation, standardization, calibration, and maintenance of ph meter including ph meter electrode care. Esd notice to protect against esd damage to electronic equipment, follow the standard esd prevention procedures. An effective equipment maintenance and calibration program ensures equipment works consistently and as intended, and that food process control points are measured accurately.