The import of the problem
The new GMP international standards corresponding to the convergence of pharmaceutical companies are facing greater opportunities and challenges, the management of the relevant departments put forward higher requirements. GMP provides guidance for pharmaceutical equipment directly involved in pharmaceutical production, such as: equipment design, selection, installation should be consistent with production requirements, easy to clean, disinfect and sterilization, ease of production operation and maintenance, and can prevent Error and pollution reduction. It can be seen that equipment management is closely related to pharmaceutical production. However, because GMP management focuses on quality control of pharmaceutical production, there is no specific requirement for equipment management. Therefore, how equipment management adapts to GMP management is equipment management department and enterprise promotion management Level and enhance competitiveness must think about and solve the problem. The following equipment management system through the analysis and the actual work of the pharmaceutical equipment management and GMP management to adapt to a brief description of the strategy.
Equipment management is a planning project, from the GMP requirements, the equipment "life" into the integrated management areas, deep into all aspects of equipment management, equipment asset management, pre-management, use and maintenance management, lubrication management, fault management Wait.
Pharmaceutical equipment management work
Equipment Asset Management
Equipment asset management is the basic component of the system, and it is the whole life cycle of the equipment and the standardized management of the resources (equipment archives, spare parts, fittings, depreciation, maintenance, lubrication, scrap, etc.) Related to the enterprise and equipment maintenance work. The computerized Maintenance Management System (CMMS) can reduce the maintenance cost, arrange the maintenance period reasonably and reduce the unnecessary maintenance times. It can improve the effective working time of the equipment management department, reduce the inventory of the spare parts, Improve the accuracy of spare parts inventory; reduce equipment downtime; improve equipment efficiency, delay the life cycle of equipment.
Equipment pre-management
Equipment pre-management of equipment from the research, planning, selection, screening, contract ordering, installation commissioning to the production process. URS (User Requirement Standard) and equipment verification and acceptance are the core contents of equipment pre-management.
1.URS
URS is the user requirements standards, is the use of equipment, plant, hardware facilities, such as the proposed use of the standard, according to the purpose of use,
URS is the basis for equipment suppliers to design and manufacture equipment. Good URS not only considers process requirements, but also meets GMP compliance and verification requirements.
2. Equipment verification and acceptance
Equipment validation and acceptance includes factory testing, field testing, validation (design validation DQ, installation validation IQ, operation confirmation OQ, performance verification PQ) and validation status maintenance of pharmaceutical equipment to ensure that pharmaceutical production equipment meets the needs of pharmaceutical production. Verification is a document that proves that the system required for verification meets the expected standards and operational consistency, including all operations that affect quality.
Equipment management departments should do a good job of acceptance verification management work should first clear the requirements of the regulatory requirements for verification, which is mandatory requirements of the GMP file; secondly clear non-GMP files (user requirements, testing, testing, etc.) and between confirmation Association and differentiation. URS, test run file (FAT, SAT) and so on to the equipment confirmation, the verification plays the vital support function.
Design validation DQ is to confirm the design and GMP in the design phase and the use of compliance, generally for custom systems; DQ should include user needs standards, design standards, supplier evaluation and so on. Installation Confirmation IQ is an assessment of the overall installation and inspection of calibration, maintenance, certification and documentation in accordance with GMP requirements. Operation Confirmation OQ is a dynamic acknowledgment that the equipment can consistently and continuously meet the functional standards required by the user. PERFORMANCE CONFIRMATION PQ is a standard that can be consistently and consistently achieved by document verification under the parameters it is set to.
Verifying state maintenance is critical for a device, process, or system that is always in a "validated" and "controlled" state and is also required by GMP. Validation status maintenance includes change control, retrospective validation, and revalidation. The equipment management department should not only carry on the retrospective verification to the pharmaceutical production equipment on a regular basis, but also should re-organize the equipment after the pharmaceutical production equipment renewal, the re-enablement, the major maintenance or the technical transformation, should strengthen the verification plan in the verification process , Verify the content of the rationality, improve the sex work, and enhance the accuracy of verification.
Equipment usage and maintenance management
Including the use of equipment preparation, cleaning, inspection, maintenance, the link to ensure the correct operation of equipment, reasonable technical maintenance, give full play to the technical performance of equipment to extend equipment life and ensure the best economic efficiency of equipment.
1. Equipment usage management
In the implementation of GMP, a notable feature is the implementation of standard operating procedures (SOP) management, that is: in the pharmaceutical production process, any related work, must be in full accordance with the SOP. This will not only improve work efficiency, but also to avoid man-made causes of work errors, the impact of drug quality. In the daily management of equipment in the implementation of SOP management, standardize the methods of work and workers operation, maintenance methods, in order to track management and improve operation and maintenance skills.
Pharmaceutical equipment should be used to strengthen preventive maintenance, pay attention to routine maintenance, strict implementation of SOP management. To better meet the needs of pharmaceutical production and reduce the dependence on the production process to ensure the stability of drug quality and improve production efficiency and product quality should be in the conditions permit, the technical transformation of equipment to improve the level of mechanical and electrical integration, At the same time pay attention to new technologies, new equipment, information collection and technical information reserves, combined with the actual production, improve the level of enterprise technology and equipment.
2. Equipment maintenance management
Equipment maintenance management, including equipment, routine maintenance, regular maintenance, prior maintenance.
Equipment routine maintenance: equipment, production management personnel should be required to operate the equipment maintenance personnel according to the implementation of SOP and check points to do a good job.
Periodic maintenance of the equipment: The equipment management department releases the plan in the form of plan, and the regular maintenance work is carried out by the operation and maintenance personnel according to the equipment maintenance and SOP. The equipment management department shall consult with the production planning department, and according to the equipment operation record and the equipment condition, at the beginning of each year, formulate the reasonable and perfect annual equipment large and medium repair plan and make the equipment spare parts purchase in advance according to the maintenance plan And processing work to ensure that large equipment, the smooth implementation of the repair plan.
Equipment maintenance in advance: that is, through a certain technical means, the various parts of the equipment status monitoring, equipment failure in advance of the occurrence of trends in the equipment failure has not yet taken measures to eliminate hidden faults. At present, the domestic pharmaceutical enterprises equipment maintenance mainly in the aftermath of maintenance-based, that is, the maintenance work in the equipment failure after the implementation of its cost is ranging from the suspension of drug production, re-drug rework or retirement, seriously affecting the quality of drugs. To meet the GMP requirements and the development of science and technology, and gradually to maintain the maintenance of prior maintenance has become a general trend. In the actual equipment management to determine the maintenance and management objectives can be selected first of the key pharmaceutical production equipment, key parts, linked production lines, such as state monitoring, carry out pre-maintenance, and gradually extended to all equipment.
At present, the traditional pharmaceutical enterprise equipment maintenance management model has obviously can not adapt to today's development requirements and competition mechanism, should make effective use of information technology, and gradually establish a preventive maintenance system equipment.
Equipment Lubrication Management
Lubrication management of pharmaceutical equipment is an important part of equipment management, production management is also an integral part. In the daily management should be strictly enforced equipment lubrication SOP requirements, so that "five" (fixed, qualitative, quantitative, fixed, timing) and "three filters. The choice of lubricants, grease, equipment and production management personnel should be based on equipment technical documents and lubrication of parts, a reasonable choice to meet the standards of lubricant. To strengthen the lubrication management of pharmaceutical equipment to ensure the normal operation of equipment, energy conservation, reduce maintenance costs, extend equipment life and reduce drug pollution is to improve the economic efficiency of enterprises and to ensure the quality of drugs an important way.
Equipment fault management
Equipment failure can be divided into design failure, operational failure of two categories. The failure of the design is caused by the inherent defect of the equipment caused by improper equipment design, material selection, manufacture and assembly, which is caused by the management of the equipment in the early stage of the equipment manufacturing level, manufacturing quality and technical level. Operation failure is due to equipment installation and commissioning, operation, daily maintenance, maintenance and repair and other natural wear and tear caused by the failure of equipment in the operation and management of the failure. First of all equipment management personnel should be categorized the fault: for example, by the location of the failure, the reasons for the alarm display, nature, actuators, interference, etc. to points. According to the above classification to determine the cause of the malfunction, and then determine the maintenance staff, improve maintenance efficiency and reduce economic losses.
Conclusion
The final form of the quality of the drug is accomplished through production, and the quality assurance of the drug production is largely dependent on the support of the equipment management and equipment systems. Nowadays, the equipment management has been modernized, the equipment management must adapt to the GMP has become inevitable, which puts forward the higher goal and the request to the equipment management, simultaneously has also brought the opportunity and the challenge. Equipment management should use modern management tools and technical means to make equipment management dynamic, in the equipment management system, into the SOP management, quantitative equipment management, equipment management system standard equipment management behavior to meet the GMP requirements to ensure the normal operation of equipment, Save energy, reduce maintenance costs, extend equipment life and reduce drug pollution, improve economic efficiency and social benefits.