Laboratory management of pharmaceutical enterprises under GMP system
- Categories:Technical articles
- Time of issue:2023-01-03
Laboratory management of pharmaceutical enterprises under GMP system
- Categories:Technical articles
- Time of issue:2023-01-03
High quality raw materials, advanced technology and equipment and scientific testing means are the three pillars of modern industry. Without advanced scientific testing means, there is no advanced product quality. From the practice of quality management development, no matter in the early stage of quality inspection, the middle stage of statistical quality management, or the modern stage of total quality management, are based on complete measurement means as the technical basis, so the laboratory is an indispensable and important department in the whole process of drug production.
In the last article we introduced the Material management module of one of the six systems for GMP inspection. This paper will introduce the laboratory management module from the following aspects: establishment of QC personnel training system, maintenance and maintenance of instruments, establishment of original record management, establishment of OOS and OOT of laboratory data, laboratory environment and hygiene management, laboratory identification management and laboratory sample management.
Instrument maintenance and maintenance
The maintenance of laboratory instruments is an important part of laboratory management. The maintenance and maintenance of the instrument is related to the good rate of the instrument, service life and the success rate of the experiment. All instruments and equipment shall be responsible for the principle of regular calibration and regular maintenance system, and corresponding instrument operation and maintenance procedures shall be formulated.
Instrument training and authorization
Before the instrument is put into use, the laboratory shall prepare the operation and maintenance procedures of the instrument and carry out training. Only authorized personnel can independently operate and maintain devices with high precision, high requirements, complex operation, or certain risk.
Use and maintenance of instruments
The instrument shall be operated in strict accordance with the operation and maintenance procedures during use, and the "Experimental Instrument Usage Record" shall be filled in time for the convenience of tracing. Equipment users should master the structure, principle, function, operation key points and maintenance requirements of the equipment to be maintained, and maintain it regularly. Pay attention to the storage environment of the instrument during use to prevent environmental deterioration and exceed the storage requirements of the instrument.
Maintenance of instruments
If the equipment is faulty, it should be affixed with an outage label to prevent misuse. After the maintenance of the experimental instrument, the laboratory is responsible for confirming the state of the instrument after maintenance, and the accuracy can be verified by means of measurement calibration, period verification, etc. Results If judged qualified, normal use will be resumed.
Free from the management of laboratory control instruments
In the case that instruments are out of the direct control of the laboratory for measurement calibration, loan and maintenance, the laboratory shall confirm the appearance (including accessories) and functional status of the instruments after they are returned, and verify the accuracy of the equipment if necessary.
Establish original records management
GMP requires that the original records must be timely, true, accurate and complete, prevent omissions and random corrections, and forgery and fabrication of data are strictly prohibited.
1. Identification: Unique, can be numbered, color, etc.
2. Storage: easy access and retrieval, records should be classified and numbered according to the content, archiving management, detailed provisions of various records of different management groups, management personnel and regular archiving interval; Clarify the permissions of various records that can be accessed by personnel in different positions; Establish requirements for personnel borrowing records.
3. Protection: moisture-proof, mothproof, fireproof, to prevent loss, damage and deterioration.
4. Security and confidentiality shall be guaranteed.
5. Electronic records should have protection and backup procedures.
6. Specify the retention period.
7. Records shall be filed at QA office timely and regularly.
8. Disposal: Destruction of records shall be approved by QA in accordance with prescribed procedures.
Establish laboratory data OOS,OOT
Data anomalies in the laboratory were investigated and tracked according to OOS, OOT and corresponding SOP. Treat the abnormal situation in the experiment positively, do not blindly cover up, so as to standardize management.
1. In the process of experimental operation and writing of experimental records, the experimenter shall immediately report any difference between experimental results or phenomena and expectations.
2. After receiving the report, the person in charge should help the experimenter analyze the reason. If experimental errors need to be corrected immediately, the error results and correction process should be recorded in the experimental records, and the processing personnel should sign for confirmation.
3. If the experimental data is not available due to experimental operation errors, the supplementary experiment or re-experiment shall be excluded after confirmation by the person in charge. The error test record shall not be deleted, and the error cause, problem analysis and solution shall be stated in the record.
4 laboratory obvious errors and other obvious errors do not need to be investigated, but the need to record in detail the relevant operation, phenomenon, analysis process and reasons in the original record, the person in charge to confirm the signature, the original data must be retained as available data.
5. When the discoverer reports OOS/OOA/OOT or suspect data, it shall be processed in accordance with the relevant regulations of OOS/OOA/OOT or Suspect Data Processing Procedures upon confirmation by the person in charge.
Laboratory environment and health management
1. Full-time personnel should be responsible for the hygiene of clean laboratory areas, and the experimental operation procedures and laboratory disinfection and sterilization methods should be strictly implemented. The laboratory should use special cleaning tools that are free from shedding, easy to clean and disinfect, and keep them properly and disinfect them regularly. Laboratory cleaning should not leave dead corners, with a thorough cleaning once a week with disinfection.
2. Before using the laboratory, the user shall conduct scientific and reasonable disinfection and sterilization treatment on the indoor ceiling, walls, floor, glass, door, surface of all instruments, indoor space and articles to be brought into the laboratory in strict accordance with the clean laboratory SOP to ensure that the environment of the clean laboratory meets the standards. Cleaning reagents are provided by the user.
3. Laboratory personnel must keep the equipment and work area clean at all times, and clean the working table after the work is finished. In the experimental operation, a rigorous operation habit should be formed to prevent the splashing or atomization of experimental materials, and resolutely prevent the pollution or corrosion of solution and reagent dripping on the ground, table and equipment.
4. After use, biological waste or pharmaceutical raw materials and other discarded items must be packed on the spot and passed out through the transfer window. All kinds of used wastes must be cleaned up and their belongings must be taken away.
5. After cleaning, it is necessary to fill in the instrument and laboratory usage record book and laboratory opening record book in detail, and close the water, electricity, gas and door.
6. All cultures, tissues, body fluid samples or potentially infectious waste must be stored in durable, nondiffusive containers and handed over to the center's full-time disinfection staff for high pressure steam sterilization and harmless treatment. Prevent diffusion into the environment during collection, handling, handling, storage, transfer or transportation, resulting in secondary pollution.
7. The air purification system and equipment should be tested regularly, and the indoor cleanliness should also be tested regularly.
8. The basic requirements for cleaning tools are as follows:
(1) not easy to shed fibers and particles, to prevent pollution.
(2) Try to use once, otherwise it should be able to wash and dry.
(3) Cleaning tools in different areas should not be mixed.
9. After use, equipment, pipes and containers should be cleaned in time, and if necessary, washed or disinfected with sterile water.
10. Disinfectants used should not contaminate equipment, materials and finished products. The disinfectant should be changed regularly to ensure the disinfection effect and prevent the generation of drug-resistant strains.
Laboratory identification management
According to different laboratory managed objects, attribute identification and status identification are used to distinguish managed objects. By nature, it can be divided into attribute identification and state identification. Attribute identification defines the inherent characteristics of things, which is invariable from beginning to end in the whole process and has the characteristics of uniqueness and traceability.
Status identification is an indicator of the ability of time-recognizing things to meet the specified quality requirements. In general, it has the characteristics of time-limit and variability, that is, the identification objects correspond to different periods and may have different states.
The main objects of identification management in laboratory activities are:
(1) Documents, archives, records and reports;
(2) test sample;
(3) Instruments and equipment, measuring instruments and standard materials;
(4) pharmaceutical reagents;
(5) Environmental area;
(1) How to establish the identification system (what content to edit, how to edit, who is responsible, to determine the relevant personnel), this needs to be unified and coordinated.
(2) The mark should not be too large, and the pasting position should not affect the normal work of the equipment.
(3) To check the mark regularly, and timely replace the expired mark, dynamic management, to avoid errors and accidents.
(4) The text, graphics and symbols of the logo should be clear and intuitive, and the content should be simple and easy for people to recognize.
(5) The logo design should reflect humanity, beautiful, easy to see, easy to understand.
(6) Correctly understand the meaning of the logo, so as to avoid mistakes in use. In the laboratory, all instruments and equipment, their software and reference materials should have obvious three-color identification to indicate their status, and the status identification contains necessary information (such as verification/calibration date, validity period, verification/calibration unit, equipment self-number, user, etc.). There are three kinds of three-color labels: qualified (green), permitted (yellow) and disabled (red).
Laboratory sample management
1. Prepare sample management procedures, including receiving, disposal, protection, storage, retention, processing or return, etc.
2. Sample reception
Check the inspection order/contract, the sample is in accordance with the commissioned requirements. Check sample identification, sample volume/quantity, appearance, packaging and other information. Record any abnormality in sample registration form and communicate with client in time.
3. Sample number identification
(1) Uniquely identify the sample according to the requirements of the program file, and post the identification on the sample. Note that the number and Posting method can be retroactive.
(2) Sample flow identification: Note that according to the status of the sample, it can be divided into four states: waiting for inspection, in inspection, finished inspection and retained sample.
4. Sample process management
(1) Identify sample storage requirements, monitor, control and record sample storage conditions according to sample storage requirements.
(2) The relevant information of the sample shall be kept confidential in strict accordance with the requirements during the transfer process.
5. Sample retention and treatment
(1) The retention period of samples shall give priority to meeting the requirements of laws and regulations and customers.
(2) When laws, regulations and customers do not require, the sample retention time shall not be less than the dispute feedback time stated in the report.
(3) Sample processing, according to customer requirements, the customer can take back the sample.
Laboratory management is a complex system engineering, in order to ensure its healthy and orderly operation, we should pay close attention to the development of standards, policies and the application and development of new technologies. This article only lists some contents of laboratory management, enterprises should draw infernal examples, improve constantly in the process of practice, promote the construction of laboratory management system, enhance technical ability and management level, to ensure the provision of accurate and reliable testing data, so as to ensure the safety of drug quality.
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