Keywords: preventative maintenance definition
Regulations of the regulatory regulators like FDA and European union require that the organizations have program for calibration and preventive maintenance for test as well as dimension equipments. Precautionary maintenance program is one of the most importance aspects for GMP inspection as it ensures the successful GMP operations. Any equipments either it is automated or manually run will perform its functions properly and are used for manufacturing, control, product packaging, labeling or keeping of drug products; it is required that it will be well-timed calibrated, inspected and examined for errors in line with the written program which is specially made to assure the best performance of the machines. This newspaper mainly discusses the value of the calibration and Preventive Maintenance program for just about any industry since it is vital for any organization that the tools produce the products having its predetermined specification.
Introduction
Definition of Calibration: - "It really is a set of procedure that performs under specific conditions to validate the ideals/data obtained by comparison of two equipment or measuring devices one which is a typical of known accuracy and reliability (Traceable to nationwide expectations). It is employed to detect, correlate, survey or eliminate any of the discrepancy in precision of instruments or measuring devices when being set alongside the standard. " [1]
Calibration is one type of comparison but it is not an alterations.
Definition of Precautionary Maintenance: "It really is a health care or service provided by staff to maintain the gear or service in satisfactorily working conditions by giving inspections, diagnosis and modification of failures before they arise. Basically they are really conducted to keep the instrument in working conditions and to extend the life of the tool. "[2]
Background Information
Today tons of equipment and calculating systems are being used in pharmaceutical industry. During pharmaceutical developing operations, these gadgets are used to control and record the GMP process variables because these parameters are mandatory to satisfy the product quality requirements of this process as well as product. WHEN I earlier mentioned that calibration is just a comparison and also to document the record of dissimilarities when calibration is conducted between the actual equipment and the typical equipment. Nonetheless it is required to calibrate the accessories timely to get the best results and minimizations of mistakes.
For PM, its one type of maintenance of calculating system or accessories before any mistake will occur. In essence PM is divided into two subparts. (1) Planned PM and (2) condition based. The main element difference between these two subparts is time necessary for maintenance. The potential risks which are participating during carrying out PM are human being errors and product failure. Preventive Maintenance is performed by repairing the instruments or by the replacing the defective part of the equipment before any mistake or product failure will take place. [1]
Main features of PM are: improvement in the stability of system, reduction in substitution cost and time, and inventory management system is also increased.
Requirements of Regulatory Authorities
Calibration program is necessary by the regulatory power (FDA) under section 21 CFR part 211. 68 and Precautionary maintenance and calibration program is required by FDA under section 21 CFR part 211. 67.
Calibration requirements for Laboratory equipment under section 21 CFR part 211. 67 are: specific guidelines, schedule, limit of exactness and accuracy remedial action and system to prevent usage of tool which are didn't calibrate. [2]
Requirements for developing area:
FDA requires that every manufacturing area of the facility has written calibration and written precautionary maintenance procedures. They must have qualified workers to calibrate and keep maintaining the equipments that are again rechecked by other competent person. They need to have one consultant to keep an eye on the calibration and PM program. And lastly the whole procedure for calibration and PM is assessed and approved in the conditions of quality.
Requirements for equipment professional list: [1]
In any developing area or any lab, lots of equipment are used that's why FDA requires that there must be something in facility that can identify the musical instruments which are related to GMP. For identification purpose it will need to have serial no. model no. and location but if the instruments are monitored by settings then this information is not mandatory. And there should be a written process that area used to determine whether calibration and PM is required for particular instrumentation or not.
Instrument Identification and calibration status[1]
Initial step for the calibration & PM program is to recognize the instrument. Musical instruments are recognized and characterize in the terms of criticality. Some instruments are critical and some are non critical. Some equipment have effects on environment so identified as environmental critical device. In the same way some has immediate impact on product quality known as GMP critical tools. Detail by detail process to recognize a musical instrument and calibration position is:
Each device is given unique identification number.
Details for device (model no, serial no, location) are available and documented
Every device is labeled with its unique identification quantity.
Calibration record (calibration status, date of calibration, date for next calibration, information on person who is executing calibration)
Use of calibration logs, calibration sticker and MAXIMO to document calibration status.
There should be considered a system which prevent the use of non-qualified equipment, damaged instruments and non-calibrated and those who expired the calibration period to minimize the problems. Also some instruments do not require calibration or manufacturing plant calibrated for certain period of time so there must be a system to identify those equipment.
Traceability of standards and calibration tolerance
Reference equipment or calibration equipment which can be used as standard should be traceable to national standard. Inside the absence of accepted standards, an independent reproducible standard can be utilized. The tolerance of the reference point standard is greater than the other equipment which is likely to be calibrated. And there must be a system available to screen the expiration particular date of guide standard and other re-certification requirements. Two types of tolerance level in calibration: (1) Alert level: Up to this level the device can be modify to its required range.
(2) Action level: It's known as out of tolerance limit. As of this level investigation is necessary for because we can not make any modification as of this level. If tolerance is between your Alert and Action level than that's fine and investigation is not needed. [1. 6]
7. Calibration and Maintenance Frequency
After factor of traceability of reference standard and calibration tolerance, the thing we need to know is frequency of calibration and maintenance because some instruments need frequent calibration. Basically the rate of recurrence of calibration will depend on the sort and nature of equipment. Some important requirements which we may take in the factor during calculation of occurrence of calibration and maintenance are listed below.
Manufacturer's tips and process requirements
Environmental conditions like temp, pressure, dampness and vibration.
History of calibration and history of repair.
8. Calibration and maintenance treatment (SOP)
There should be considered a documented SOP for performing the calibration and precautionary maintenance for each type of instrumentation. More often than not during calibration, dimension of errors is available exceeded to its limit by one or more specified point as it was shown in number: 1 as "As found" and secondly calibration is carried out to verify its predetermined tolerance limit which is shown in the shape: 1 as "As kept". The SOP for calibration must includes exactness and precision limitations and what exactly are the remedial activities should be taken if this boundaries do not talk with each other. There must be an authorized office to execute and keep an eye on calibration and maintenance. The SOP must contain the step by step calibration instructions, instrumentation manual, proper calibration methods, provisions for changes, procedures for record and record the actual measurement reading before and after doing modification.
Record/Paperwork for calibration and maintenance
Documentation for calibration and PM is vital as out of this historical data we are able to minimize mistakes for future perspective. Genuine measurements and the data obtained after adjustment are documented as shown in the Shape: 1. Records must includes the tolerance limit, full details of the reference point standard used and complete information on the person who do the calibration. Each one of these documentations are assessed periodically by approved person to help make the adjustment in the rate of recurrence of calibration when recalibration of the musical instruments will be carried out in future.
Today the majority of the pharmaceutical companies are using computerized calibration management system to plan and track record the calibration activities in their organization. Computerized system is more convenient and successful than the traditional paper work. You save the data for longer time. At the start, the computerized system is not popular much but after the introduction of 21 CFR part 11 - digital records and electronic signature, the majority of the organizations used it.
Out of tolerance (OOT) calibration result
When we discovered that the particular device is outside of its predetermined calibration boundaries which is also called Action limit or OOT. If we found OOT calibration final result, first situation is to have corrective actions as soon as possible. We can take corrective actions like repair, re-calibration, and replacement of faulty part or permanent removal of instrument if the mistakes can't be corrected by above actions. Firm can concern OOT notification to the vendor and the notification must includes current calibration data, severity of OOT error and full details of previous successful calibration. It is compulsory that QA office immediately stop the creation for a while till the issue is solved. Here the role of PM is important as it'll stop the reoccurrence of the error. As OOT results highly impact on the quality of the merchandise and also in charge of batch failure, it is obligatory to find out the primary cause for the event of these problems. At least it will help us to avoid the re-occurrence of particular problem.
Change control management and CAPA approach
Under change control management program, we're able to make changes in calibration tolerance, consistency and technique. Also we can add another new program to avoid mistakes or everlasting removal of current program to avoid hassle. Change in the environment or change in the positioning is also solution recommended by this program. Each and every step should be documented properly. This program also implies revalidation, re-execution and revision of IQ, OQ and PQ of the tools. Timely revision, regular review and acceptance by approved person at every stage are the tips of this program.
CAPA stands for corrective actions and Preventive activities. CAPA can be an important analytical tool to solve lot of issues. CAPA is a concept of Good Manufacturing practice (GMP). CAPA mainly concentrate on the systematic exploration of the failures and deviations took place during process to avoid their reoccurrence in the conditions of corrective activities and also prevent from reoccurrence in conditions of preventive action. [5] CAPA ensures that the corrective activities and Preventive activities that are under taken to prevent inability are highly effective and reliable. CAPA can be an important tool of the entire Quality Management System (QMS). If any company wants to have best value management system in their organization, they should implement CAPA to their organization. CAPA ensures the very best quality products with the lower cost and less time.
Software used for calibration and PM
Lots of softwares are being used for calibration and PM at industrial range. This computerized system has more efficiency and guaranteed the best results.
Calibration software
Quality Calibration Management system (QCMS) is complete tool and designed in line with the requirements of 21 CFR part 11. This software ensures regulatory compliance and also traceability. It can help to enhance the reliability of plant and improve the administrative costs. It will help to increase in the production as well as efficiency.
12. 2 Precautionary maintenance software
RCM turbo is very popular PM software. Traditional procedure had taken years to complete just one single PM but employing this RCM turbo, anyone can easily go for PM. This software directs us through EMEA process. But the thing could it be will go through quickly and efficiently. It is 100 % reliable and will enable you do risk assessment
Conclusion
In conclusion, I would like to state that calibration and precautionary maintenance are extremely important areas of any instrument. To get the best results with the musical instruments, it is mandatory to check and calibrate the devices periodically as additionally it is required by regulatory government bodies. Preventive maintenance definitely increases the life of the devices but timely execution of PM is vital. Non-calibrated tools and lack of PM has immediately impact on the product quality, so it needed that every creation area in the company has proper program for validation and PM. We can not neglect the importance of PM because it will avoid the re-occurrence of mistakes. SOP for calibration and PM is also valuable aspect as it can help to track record data, minimize the severity of risk and provides step-by-step procedure to check out. CAPA procedure is one of the most crucial quality management tools as it will help to correct the errors also to avoid the re-occurrence of mistakes by preventive actions. Execution of CAPA tool in calibration will definitely good for devices. Revision of 21CFR part 11 highly suggests implementing computerized software system to every organization due to its convenience and efficiency. Softwares used for calibration and PM as I mentioned in the newspaper like QCMS and QMS turbo etc. are 100 % reliable, so I would like to suggest every organization to look at this computerized software system for his or her calibration and PM program.
