Countermeasures for the management of pharmaceutical equipment and GMP

Keywords: equipment management; verification; use; maintenance

1 problem import

With the new version of GMP coming soon and in line with international standards, pharmaceutical companies are facing greater opportunities and challenges, and put forward higher requirements for the management of relevant departments. GMP provides guidance on pharmaceutical equipment directly involved in pharmaceutical production. For example, equipment design, selection, and installation should meet production requirements, easy to clean, disinfect, and sterilize, facilitate production operations, maintenance, and maintenance, and prevent Errors and reduced pollution. It can be seen that equipment management has a close relationship with pharmaceutical production. However, since GMP management focuses on the quality management of pharmaceutical production, there is no specific requirement for equipment management. Therefore, how equipment management is compatible with GMP management is the equipment management department and enterprise management. Levels and issues that must be considered and addressed by enhancing competitiveness. The following is a brief description of the countermeasures for the adaptation of pharmaceutical equipment management and GMP management by analyzing the equipment management system and combining the actual work.

Pharmaceutical equipment management is a planning project. It is necessary to start from the GMP requirements, integrate the equipment “lifelong” into the comprehensive management category, and go deep into all aspects of equipment management, namely equipment asset management, pre-management management, use and maintenance management, lubrication management, fault management. Wait.

2 Pharmaceutical equipment management work

2.1 Equipment Asset Management

Equipment asset management is a basic component of the system. It manages the life cycle and standardization of equipment assets of various resources (equipment files, spare parts, accessories, depreciation, repair, maintenance, lubrication, scrapping, etc.) related to the maintenance work of enterprises and equipment. At present, the computerized equipment asset management and maintenance system (CMMS: ComputerizedMaintenance Management System) can reduce maintenance costs, arrange maintenance intervals reasonably, reduce unnecessary maintenance times, improve the effective working time of equipment management departments, reduce spare parts inventory, and improve spare parts inventory. Accuracy; reduce equipment downtime; increase equipment efficiency and delay equipment life cycle.

2.2 Equipment pre-management

Pre-equipment management is the process from equipment research, planning, selection, screening, contract ordering, installation and commissioning to commissioning. URS (User Requirements Standard) and device verification acceptance are the core content of pre-device management.

2.2.1URS

URS is a user requirement standard, which is a requirement standard used by the user for equipment, plant, hardware facility system, etc., 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 considers compliance with GMP and verification requirements. Its important role in the early management of equipment is shown in Figure 1.

Figure 1URS shows

2.2.2 Equipment verification and acceptance

Equipment verification and acceptance includes factory testing, field testing, four validations (design validation DQ, installation validation IQ, operational validation OQ, performance validation PQ) and verification status maintenance of pharmaceutical equipment to ensure that pharmaceutical production equipment meets the needs of pharmaceutical production. Verification is a document that demonstrates that the system to be validated meets the expected standards and operational consistency, including all operations that affect quality.

The equipment management department must do a good job in the acceptance verification management work. First, the requirements of the regulations for verification should be clarified, and what are the GMP documents required by the regulations; secondly, the non-GMP documents (user requirements standards, test machines, tests, etc.) and confirmation Association and difference. URS, test run files (FAT, SAT), etc. play an important supporting role in equipment verification and verification.

The design confirms that DQ confirms the conformity of the design to GMP and intended use during the design phase, generally for custom systems; DQ should include user requirements standards, design standards, supplier evaluations, etc. Installation Confirmation IQ is an overall installation evaluation and inspection of calibration, maintenance, certification and documentation in accordance with GMP requirements. Operational Confirmation OQ is a dynamic confirmation that the equipment meets the functional standards required by the user consistently and continuously. Performance Confirmation PQ is a document that demonstrates that the pre-set criteria can be achieved consistently and consistently when produced under the parameters set.

Verifying state maintenance is critical to the "verified" and "controlled" state of a device, process, or system, and is also required by GMP. Maintenance of verification status includes change control, retrospective verification, and revalidation. The equipment management department should not only periodically verify the pharmaceutical production equipment, but also re-organize the equipment after the pharmaceutical production equipment is updated, re-enabled, major repaired or technically modified; the verification scheme should be strengthened during the verification process. Improve the rationality and perfection of the content and enhance the accuracy of the verification.

Figure 2 shows the device verification life cycle (V-shaped diagram), which shows the intrinsic and difference between the two key aspects of equipment pre-management.

Figure 2 device verification life cycle

2.3 Equipment use and maintenance management

Including the equipment preparation, cleaning, inspection, maintenance, this link to ensure the correct operation of the equipment, reasonable technical maintenance, give full play to the technical performance of the equipment, extend the service life of the equipment, and ensure the economic benefits of the equipment.

2.3.1 Equipment Usage Management

In the implementation of GMP, a significant feature is the implementation of Standard Operating Procedure (SOP) management, that is, in the pharmaceutical production process, any work related to it must be carried out in full accordance with the SOP. This will not only improve work efficiency, but also avoid work errors caused by human factors and affect the quality of drugs . Implement SOP management in the daily management of equipment, standardize working methods and worker operation and maintenance methods, in order to track management and improve operation and maintenance skills.

Preventive maintenance should be strengthened in the use of pharmaceutical equipment, focusing on routine maintenance and strict implementation of SOP management. In order to better meet the needs of pharmaceutical production, reduce the dependence on people in the production process, ensure the stability of drug quality, improve production efficiency and product quality, technical transformation of equipment should be carried out under conditions permitting, and the level of mechatronics should be improved. At the same time, it pays attention to the collection of information and technical data of new technologies and new equipment, and combines the actual production of enterprises to improve the level of technical equipment.

2.3.2 Equipment Maintenance Management

Equipment maintenance management includes routine maintenance, regular maintenance, and prior maintenance.

Routine maintenance of equipment: Equipment, production management personnel should require operators to perform maintenance according to equipment maintenance SOP and do a good inspection.

Regular maintenance of equipment: The equipment management department releases the implementation in the form of a plan, and the maintenance work is performed by the operation and maintenance personnel according to the equipment maintenance SOP. For the equipment large and medium repair plan, the equipment management department should consult with the production planning department, according to the equipment operation record and equipment status, formulate a reasonable and perfect annual equipment large and medium repair plan at the beginning of each year, and purchase equipment spare parts in advance according to the maintenance plan. And processing work to ensure the smooth implementation of large equipment and medium maintenance plans.

Pre-maintenance of the equipment: that is, through certain technical means, the status of each part of the equipment is monitored, and the occurrence trend of the equipment failure is found in advance, and measures are taken to eliminate the hidden troubles when the equipment failure has not occurred. At present, the maintenance of equipment in domestic pharmaceutical enterprises is mainly based on after-sales maintenance, that is, the maintenance work is carried out after the equipment fails. The price is that the production of medicines is interrupted, and the rework or scrapping of the medicines is seriously affected, which seriously affects the quality of the medicines. In order to meet the requirements of GMP and the development of science and technology, it has become an irresistible trend to gradually replace the after-the-fact maintenance with prior maintenance. In the actual equipment management, the maintenance management objectives can be selected to first monitor the status of key equipment, key parts, and linkage production lines in the pharmaceutical production process, carry out pre-maintenance, and gradually promote to all equipment.

At present, the traditional pharmaceutical enterprise equipment maintenance management model has obviously not been able to adapt to today's development requirements and competition mechanism, and should effectively use information technology to gradually establish a preventive maintenance system for equipment.

2.4 Equipment lubrication management

Lubrication management of pharmaceutical equipment is an important part of equipment management and an integral part of production management. In the daily management, the equipment lubrication SOP regulations should be strictly implemented to achieve “five fixed” P, ul*e (fixed point, qualitative, quantitative, fixed, timed) and “three-level filtering”. For the selection of lubricants and greases, equipment and production management personnel should select lubricants that meet the standards according to the equipment technical documents and lubrication parts. Strengthening the lubrication management of pharmaceutical equipment, ensuring the normal operation of equipment, saving energy , reducing maintenance costs, extending the service life of equipment and reducing drug pollution are important ways to improve the economic efficiency of enterprises and ensure the quality of medicines.

2.5 Equipment Fault Management

Equipment failures can be classified into design faults and operational faults. The design failure is restricted by the level of equipment manufacturer, manufacturing quality, and technical level. It is a fault caused by improper equipment defects caused by improper design, material selection, manufacturing, assembly, etc. It is a fault caused by the early management of the equipment. Operation failure is caused by equipment installation and commissioning, operation, daily maintenance, maintenance and repair, and natural wear and tear. It is the fault caused by the equipment in operation management. First, the equipment manager should classify the fault: for example, according to the location of the fault, the cause of the fault, the way the alarm is displayed, the nature, the actuator, the interference, etc. According to the above classification, the cause of the fault is determined, and then the maintenance personnel are determined, the maintenance efficiency is improved, and the economic loss of the enterprise is reduced.

3 Conclusion

The finalization of the quality of the drug is completed through production. Therefore, the quality assurance of the drug production depends to a large extent on the support of the equipment management and equipment system. Nowadays, equipment management has become more modern, and equipment management must be compatible with GMP. This has set higher goals and requirements for equipment management, but also brings opportunities and challenges. Equipment management should adopt modern management tools and technical means to make equipment management dynamic. In the equipment management system, integrate SOP management, quantify equipment management, and standardize equipment management behavior with equipment management system to meet GMP requirements and ensure normal operation of equipment. Save energy, reduce maintenance costs, extend equipment life and reduce drug pollution, and improve economic and social benefits.