There are various services available to ensure your equipment is regularly. Sop for laboratory instrument qualification pharma beginners. All equipment that requires calibration shall be labelled, coded, or otherwise identified to indicate the status of calibration, including the last date of calibration and date of expiration or due date of next calibration equipment sent out of the laboratory must be recalibrated or. Sops stores sops checklists maintenance sops hplc sterile glp validation protocols water system gdp regulatory maintenance calibration warning letters follow pharmaguideline. This sop lists, details and defines each of the 11 essential elements of cgmp compliant calibration and calibration management. Standard operating procedures university of california. For over 40 years, lab pro has been committed to delivering a complete laboratory solution by offering the highest quality calibration and measuring instruments, chemicals, reagents, microscopes and imaging equipment for our customers worldwide. Come visit the biggest lab supply showroom in the bay area, or contact us online or at 8884522776. Standard operating procedure for laboratory instrument and equipment calibration through internal or external third party. Equipment used in animal facilities for animal health assessment or dosing. Equipment sent out of the laboratory must be recalibrated or. This sop is applicable for operation, calibration, cleaning and maintenance of bacteriological incubator in microbiology lab pharmaceutical company name. Who expert committee on specifications for pharmaceutical. It is the fourth sop in the group of analysis sops.
Records include instrument related information such as descriptions of. Detailed instructions of equipment use should be sourced from the manufacturers operator manual. Document templates are valuable tools and standard operating procedure. Questions and answers on current good manufacturing. Equipment calibration and maintenance procedure simulab. Data relating to the calibration of laboratory inspection, measuring. Abbreviations and definitions for general abbreviations, definitions and terminology see qm 1 general. Locate supplies used daily close to the work area and place items used periodically on nearby storage areas. Sop standard operating procedures an sop is a written laboratory specific document which details the method of an operation or analysis with procedures thoroughly described.
Calibration procedure guidelines for measuring instruments lab. Wastewater laboratory basics sampling, ammonia, bod, chlorine residual, fecal coliform, ph, solids. Draper laboratory csdl, or another qualified calibration service, will perform all necessary inspections, repairs, and calibrations in accordance with the requirement established by milstd45662. Fda standards on calibrating lab equipment are not so tough edword simpson posted on. List of standard operating procedures sops for quality control laboratories in pharmaceutical products manufacturing facilities. The us fdas insistence on laboratory audits begs two pertinent questions. Laboratory equipment care and maintenance conduct science.
This sop is applicable to all staff members working with this machine. The sop is the accepted method for performing certain routine and repetitive tasks. Fda standards on calibrating lab equipment are not so. All instructions, standards, manuals and reference data relevant to the work of the ats. Standard operating procedures good laboratory practices. Questions and answers on current good manufacturing practices equipment. Standard operating procedure laboratory housekeeping. Calibration policies for laboratory instruments gmpsop. Any instrument that is used in the pharmaceutical industries, small laboratories and health care industries is required to always provide reliable and accurate data. Calibration sop of respective instrument equipment shall mention the calibration schedule and acceptance criteria. Meade, md standard operating procedure for calibration of thermometers sop number. Regular calibration of laboratory equipment should be done because over time, biases develop in relation to the standard unit of measure.
Laboratory equipment thermo fisher, labconco, perkin elmer. Sop on operation, calibration, cleaning and maintenance of. Control, weighing, measuring, monitoring and test equipment that is critical for assuring the quality of intermediates or apis should be calibrated according to written procedures and an established schedule. For commercial off the shelf equipment pq may be satisfied by calibration, system suitability tests and the routine maintenance of the analytical equipment. Operation, calibration, cleaning and maintenance of. This procedure applies to the laboratory equipment used by the laboratory of xxx.
Scope this procedure applies to the laboratory equipment used by the laboratory of xxx. Ensures laboratory equipment is calibrated and maintained in accordance with accreditation requirements. This calibrationcertification is memorialized by a written label with date affixed to the equipment. A04 as the sop has been revised twice, the current version of this sop is number 3. Eq0203 date revised 042505 page 5 of 6 archived in the point check calibration of laboratory thermometers record book. In the laboratory each piece of equipment or instrument is labelled to indicate the frequency of its calibration. Equipment which requires calibration shall not be used if satisfactory calibration cannot be achieved or the calibration date has passed. Ich good manufacturing practice guide for active pharmaceutical ingredients, 10 november. Sop for calibration of instruments in production and.
Sops are written instructions that detail the steps to be performed during a. Standard operating procedures sops are a must for all complex lab equipment. It includes sample document formats, calibration labels layouts and details the importance of the post calibration report. For labs doing npdes compliance testing, sops should be. Not all the equipment present in the laboratory needs to be supplied with an sop. This sop includes the calibration procedure, scheduleplanner and frequency of instrument calibration in quality control laboratory.
This procedure applies to all pfizer colleagues and to. Equipment number and logged in an equipment register kept in laboratory. The sop describing use and maintenance of the centrifuge is an equipment sop, this is indicated by the e. Calibration methods and frequency noted in sop s relevant to the equipment or instrumentation. Military standard 45662, calibration system requirements. To lay down the procedure for operation, calibration, cleaning and maintenance of bod incubator. All the calibration process or procedures performed on all test. This procedure specifies the schedule and requirements for calibration, performance verification, and maintenance of laboratory testing instruments and equipment. 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. Equipment qualification for analytical laboratory instruments. Mar 04, 2020 the purpose of this standard operating procedure sop is to describe the procedure for qualification of laboratory instrument equipment. Calibration requirements can be found in tb 43180 calibration and repair requirements for maintenance of army material, applicable astm methods. A record of calibration results is maintained at the field laboratory for the equipment listed in figure 61. Please see your equipment sops for further guidance 8.
Procedure for calibration of instruments equipments. Accuracy and integrity of an instrument is established through qualification, calibration and validation. Such calibration is carried out by using standards available in laboratory. Part a develop a laboratory equipment and calibration sop. Mentioned below is a typical process that needs to be followed for equipment calibration. For a one point calibration, the range is the target level, i. Determine for which pieces of equipment sops need to be written.
Calibration instructions must be applied in accordance with equipment specific sop 7. Ensure materials, chemicals, and equipment that are no longer needed, are disposed of properly or turned in as excess. Standard operating procedures sops standard operating procedures sops incorporating safety and health considerations must be developed and followed when laboratory work involves the use of hazardous chemicals, especially particularly hazardous substances. There shall be an sop for calibration of each instrument equipment which needs periodic inhouse calibration. Page no 5 of 12 laboratory for production measurement sop 6 calibration of vernier calliper gauges issue no. Providence rd, suite 1050, media, pa 19063, usa summary writing standard operating procedures sops for laboratory equipment. See sop use and storage of peroxideforming chemicals.
Laboratory standard operating procedure equipment calibration schedule gensop 10. Refer to the laboratorys equipmentspecific or calibration sop as needed to prevent duplication. Test equipment calibration the equipment furnished for testing is required to be properly calibrated and maintained within the calibration limits described in the applicable test method. Equipment used in animal facilities for the generation, measurement, or assessment of research data should be decontaminated with oxivir tb prior to and after each use in accordance with sop 1015, and appropriately maintained to ensure quality performance. The calibration program is one of the key quality systems for successful gmp operations as well as for ensuring compliance during regulatory inspections. All testing equipment shall be calibrated and the record of calibration, routine.
Before sharing sensitive information, make sure youre on a federal government site. Sop for calibration of thermometer processor or designee will calibrate the thermometers prior to use by using the specifications of the manufacture of the equipment this will vary or the following procedures will be implemented. Calibration procedures for measuring instruments, industry guidelines and possible issues labs might face if they did not follow said guidelines. If the item requires calibration, the calibration administrator shall ensure that the equipment is identified held for calibration and segregated from use until the calibration effort is completed. 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. This section describes the purpose of preparing and maintaining the sop. Equipment in animal facilities not used in the generation of data. The exact process of equipment calibration shall vary according to the type of instrument, how critical its role is in the operation and standards that are followed for the calibration purpose. See sop laboratory ergonomics and laboratory ergonomics workbenches. Providence rd, suite 1050, media, pa 19063, usa summary writing standard operating procedures sops for laboratory equipment is viewed as a necessary evil.
Standard operating procedures good laboratory practices good measurement practices proficiency testing state lab program resources lab metrology training laws and regulations. A calibration curve is a method for determining the concentration of a. This ensures that the correct use and maintenance of the equipment is integrated within routine work. To lay down the procedure for operation, calibration, cleaning and maintenance of bacteriological incubator. Introduction the aim of the calibration system is to endure that all measuring and test equipment whose accuracy influences the quality of test results shall be calibrated at. Third party may take instrument outside premises 5. Sop provides general safety procedures for laboratory housekeeping. Annual thermometer calibration reports for nist traceable. Standard operating procedure laboratory housekeeping page. Calibration of temperature control and monitoring devices. 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. This sop is applicable for operation, calibration, cleaning and maintenance of bod incubator in microbiology laboratory at pharmaceutical formulation plant. This sop shall be used as such for qualification of laboratory instrument equipment in the quality control department in the pharmaceutical manufacturing plant. Procedure for equipment calibration and maintenance trace.
Calibration shall be done using certified calibration standards traceable to nationalnist standards either inhouse or from a certified outside agency. Calibration involves comparing the measurements of an equipment against the standard unit of measure, for the purpose of verifying its accuracy and making necessary adjustments. This sample calibration procedure defines the calibration program requirements for all measurement and test equipment mte. Calibrations conducted under field and laboratory conditions are not considered equivalent and uncertainties must reflect the conditions of the calibration. Lab instruments, equipment and supplies from trusted brands laboratory equipment provides innovative, quality scientific research equipment from toptier suppliers, including thermo fisher, labconco, sartorius, perkinelmer, ika, sheldon, binder and benchmark scientific. Qse 4 equipment additional information is also contained in the general equipment use and calibration sop checklist. Sop for calibration of instruments in production and quality control. Scope of the quality manualareas to which this qm applies. Following these simple cleaning procedures will keep equipment in peak condition so that your lab runs without a hitch. Calibration program gmp sop standard operation procedure.
Test equipment calibration is not traceable to the us national institute standard of technology nist, but to the. Standard operating procedure sop for disintegration apparatus dt apparatus for operation and various calibration parameters as per indian pharmacopoeia. Control charts of laboratory owned check standards. Such calibration is carried out by the third party. A robust calibration program is the basis for all operations associated with any qualityrelated measurement. Region 1 calibration of field instruments revision number. Wherever possible, calibration should be carried out in accordance with the device manufacturers instructions, or by following a devicespecific sop. Are such auto calibration procedures acceptable instead of external performance checks. An overview michelle rosa parexel consulting, a division of parexel international 1400 n. Procedure for equipment calibration and maintenance. Calibration sop for disintegration apparatus dt pharma. Fda standards on calibrating lab equipment are not so tough.
Sop 1103 equipment maintenance calibration university of south. Failure to regularly calibrate equipment can lead to a lack of accuracy with your data which could end up disrupting entire experiments. Wastewater laboratory basics illinois water environment. These shall be prepared internally, by another agency, the manufacturer or a composite of any of these. Written calibration procedures that use traceable calibration standards or calibration equipment. Trp trp89 realtime pcr detection system ct threshold cycle lm laboratory manager lt laboratory technologist rt room temperature tm melting temperature. Equipment or instruments on the calibration programme are labelled when out of calibration. Equipment and instrumentation to be calibrated and its location. Calibration and preventative maintenance procedures. Sop for preventive maintenance of production equipment.
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