Calibration and Preventive Maintenance Program

standardisation and duty tour alimony ProgramRegulations of the regulatory authorities the likes of FDA and EU require that any the firms have platform for standardisation and healthful maintenance for test as well as measurement equipments. noise maintenance program is adept of the around importance perspectives for GMP inspection as it ensures the efficient GMP operations. Any equipments each it is automatic or manually operated pass on perform its functions appropriately and argon employ for manufacturing, do working, packaging, labeling or holding of drug crossways it is mandatory that it exit be timely calibrated, inspected and checked for mistakes according to the written program which is specially intentional to assure the best performance of the equipments. This theme mainly discusses the importance of the normalisation and Preventive living program for any industry because it is very central for any firm that the equipments produce the mathematica l products having its mold specification.IntroductionDefinition of normalisation It is a set of operation that performs under specific conditions to verify the determine/data obtained by comparison of two factors or measuring devices champion of which is a standard of known accuracy (Traceable to national standards). It is utilize to detect, correlate, embrace or eliminate any of the discrepancy in accuracy of instruments or measuring devices when being comp bed to the standard. 1Calibration is one type of comparison entirely it is not an trying ons.Definition of Preventive Maintenance It is a c ar or service provided by individualnel to maintain the equipment or facility in satisfactorily working conditions by providing inspections, detection and reclaimion of failures shorter they occur. essentially they atomic number 18 conducted to keep the instrument in working conditions and to extend the flavour of the instrument.2Background InformationToday green goddesss of equipment and measuring dusts ar use in pharmaceutical industry. During pharmaceutical manufacturing operations, these equipments are used to control and show the GMP process parameters because these parameters are mandatory to fulfill the quality requirements of the discovericular process as well as product. As I earlier mentioned that normalization is just a comparison and to document the record of differences when standardisation is performed in the midst of the actual equipment and the standard equipment. But it is mandatory to calibrate the equipments timely to annoy the best results and minimizations of errors.For PM, its one type of maintenance of measuring frame or equipments before any error give occur. Basically PM is divided up into two subparts. (1) Planned PM and (2) condition based. The detect difference between these two subparts is time indispensable for maintenance. The essays which are involved during performing PM are human errors and product failu re. Preventive Maintenance is performed by repairing the equipments or by the replacing the unfit part of the equipment before any error or product failure will occur. 1Main advantages of PM are improvement in the dependableness of administration, decrease in replacement comprise and time, and inventory focal point system is also improved.Requirements of Regulatory AuthoritiesCalibration program is required by the regulatory authority (FDA) under incision 21 CFR part 211.68 and Preventive maintenance and normalization program is required by FDA under section 21 CFR part 211.67.Calibration requirements for research laboratory instruments under section 21 CFR part 211.67 are specific directions, schedule, dividing line of accuracy and precision remedial action and system to prevent usance of instrument which are failed to calibrate. 2Requirements for manufacturing nationFDA requires that each manufacturing area of the facility has written normalisation and written preventive maintenance influences. They moldinessiness have fit personnel to calibrate and maintain the equipments which are again rechecked by other(a) qualified person. They must have one representative to monitor the normalization and PM program. And finally the whole process of normalization and PM is reviewed and approve in the terms of quality.Requirements for equipment master list 1In any manufacturing area or any laboratory, lots of instruments are used thats why FDA requires that at that place should be a system in facility that rump delineate the instruments which are related to GMP. For realisation purpose it must have back-to-back no. model no. and location but if the instruments are bring in by configuration then this information is not mandatory. And there should be a written procedure that area used to determine whether standardization and PM is required for particular instrumentation or not.Instrument credit and calibration status1Initial stair for the calibrati on PM program is to cite the instrument. Instruments are identified and characterize in the terms of criticality. Some instruments are critical and some are non critical. Some instruments have effects on environment so identified as environmental critical instrument. In the same way some has direct impact on product quality known as GMP critical instruments. Step by footstep process to identify an instrument and calibration status isEach instrument is given unique identification number.Details for instrument (model no, serial no, location) are available and documentedEvery instrument is labeled with its unique identification number.Calibration history (calibration status, period of calibration, date for next calibration, details of person who is performing calibration)Use of calibration logs, calibration sticker and MAXIMO to document calibration status.There should be a system which prevent the use of non-qualified instruments, alter instruments and non-calibrated and those wh o expired the calibration period to minimize the errors. also some instruments do not require calibration or factory calibrated for authoritative period of time so there should be a system to identify those instruments.Traceability of standards and calibration gross profit marginReference equipment or calibration equipment which is used as standard should be traceable to national standard. In the absence of recognized standards, an independent reproducible standard female genital organ be used. The valuation reserve of the reference standard is higher than the other equipment which is going to be calibrated. And there should be a system available to monitor the expiration date of reference standard and other re-certification requirements. Two types of tolerance level in calibration (1) rattling level Up to this level the instrument can be adjust to its required range.(2) Action level Its known as out of tolerance limit. At this level investigation is required for because we monger make any adjustment at this level. If tolerance is between the Alert and Action level than thats fine and investigation is not required. 1.67. Calibration and Maintenance FrequencyAfter consideration of traceability of reference standard and calibration tolerance, the social occasion we direct to know is frequency of calibration and maintenance because some instruments need frequent calibration. Basically the frequency of calibration depends on the type and nature of instruments. Some important criteria which we can take in the consideration during count of frequency of calibration and maintenance are listed below.Manufacturers recommendations and process requirementsEnvironmental conditions like temp, pressure, humidity and vibration.History of calibration and history of repair.8. Calibration and maintenance procedure (SOP)There should be a documented SOP for conducting the calibration and preventive maintenance for each type of instrumentation. Most of the time during c alibration, measurement of errors is found exceeded to its limit by one or more designated point as it was shown in figure 1 as As found and secondly calibration is carried out to verify its predetermined tolerance limit which is shown in the figure 1 as As left. The SOP for calibration must includes accuracy and precision limits and what are the remedial actions should be taken if this limits do not meet with each other. There should be an permit department to perform and monitor calibration and maintenance. The SOP must contain the step by step calibration instructions, instrumentation manual, proper calibration procedures, nutriment for adjustments, provisions for record and document the actual measurement reading before and after doing adjustment.Record/Documentation for calibration and maintenanceDocumentation for calibration and PM is very important as from this historical data we are able to minimize errors for future perspective. Actual measurements and the data obtaine d after adjustment are recorded as shown in the Figure 1. Documentation must includes the tolerance limit, wide-eyed details of the reference standard used and realised details of the person who did the calibration. All these documentations are reviewed periodically by authorized person to make the adjustment in the frequency of calibration when recalibration of the instruments will be carried out in future.Today most of the pharmaceutical companies are using computerized calibration management system to plan and record the calibration activities in their firm. Computerized system is more convenient and efficient than the traditional paper work. You can save the data for longer time. At the beginning, the computerized system is not popular much but after the introduction of 21 CFR part 11 electronic records and electronic signature, most of the organizations adopted it.Out of tolerance (OOT) calibration resultWhen we found that the particular instrument is outside of its predeter mined calibration limits which is also known as Action limit or OOT. If we found OOT calibration result, first scenario is to take disciplinal actions as soon as possible. We can take corrective actions like repair, re-calibration, and replacement of defective part or permanent removal of instrument if the errors cannot be reverse by above actions. Firm can issue OOT notification to the vender and the notification must includes current calibration data, severity of OOT error and full details of last successful calibration. It is mandatory that QA department immediately tick the production for a while till the issue is solved. Here the fibre of PM is important as it will stop the reoccurrence of the error. As OOT results exceedingly impact on the quality of the product and also responsible for plenteousness failure, it is mandatory to find out the root cause for the occurrence of these errors. At least it will help us to prevent the re-occurrence of particular error. deviate c ontrol management and CAPA approachUnder change control management program, we are able to make changes in calibration tolerance, frequency and procedure. Also we can add another new program to avoid errors or permanent removal of current program to avoid inconvenience. Change in the environment or change in the location is also dissolver suggested by this program. Each and each step should be documented properly. This program also suggests revalidation, re-execution and revision of IQ, OQ and PQ of the instruments. Timely revision, periodic review and approval by authorized person at every stage are the key points of this program.CAPA stands for corrective actions and Preventive actions. CAPA is an important analytical tool to solve lot of issues. CAPA is a concept of Good Manufacturing practice (GMP). CAPA mainly concentrate on the systematic investigation of the failures and deviations occurred during process to prevent their reoccurrence in the terms of corrective actions and also prevent from reoccurrence in terms of preventive action. 5 CAPA ensures that the corrective actions and Preventive actions that are under taken to prevent failure are highly effective and reliable. CAPA is an important tool of the overall Quality Management agreement (QMS). If any company wants to have best quality management system in their firm, they should implement CAPA to their firm. CAPA ensures the best quality products with the lower cost and little time.Software used for calibration and PMLots of packets are used for calibration and PM at industrial scale. This computerized system has more aptitude and guaranteed the best results.Calibration packageQuality Calibration Management system (QCMS) is arrest instrument and designed according to the requirements of 21 CFR part 11. This software ensures regulatory compliance and also traceability. It will help to improve the reliability of plant and optimize the administrative costs. It will help to increase in the produ ctivity as well as efficiency.12.2 Preventive maintenance softwareRCM turbo is very popular PM software. Traditional approach took years to complete just one PM but by using this RCM turbo, anyone can quickly go for PM. This software directs us through EMEA process. But the issue is it will go through quickly and efficiently. It is 100 % reliable and will allow you do risk assessmentConclusionIn conclusion, I would like to say that calibration and preventive maintenance are very important aspects of any instrument. To get the best results with the instruments, it is mandatory to inspect and calibrate the instruments periodically as it is also required by regulatory authorities. Preventive maintenance definitely improves the life of the instruments but timely implementation of PM is very important. Non-calibrated instruments and lack of PM has directly impact on the product quality, so it required that every manufacturing area in the firm has proper program for validation and PM. We cant neglect the importance of PM because it will prevent the re-occurrence of errors. SOP for calibration and PM is also valuable aspect as it will help to record data, minimize the severity of risk and provides step by step procedure to follow. CAPA approach is one of the most important quality management tools as it will help to correct the errors and to prevent the re-occurrence of errors by preventive actions. Implementation of CAPA tool in calibration will definitely good for instruments. Revision of 21CFR part 11 strongly suggests adopting computerized software system to every firm because of its convenience and efficiency. Softwares used for calibration and PM as I discussed in the paper like QCMS and QMS turbo and so forth are 100 % reliable, so I would like to suggest every firm to adopt this computerized software system for their calibration and PM program.