One, GMP requirements for pharmaceutical QC laboratory personnel
QC laboratory should be equipped with a certain number of management and inspection personnel with the appropriate professional knowledge, the specific requirements are as follows:
(1) the department head should be a college degree or above in pharmaceuticals or related disciplines, and the person in charge should be able to effectively organize, guide and carry out the business of this room. Have drug quality inspection and management of practical work experience, can effectively organize, guide and carry out the business work of the department, the drug test related issues can make timely and correct judgment and treatment, and is responsible for the test results.
(2) drug testing staff need to undergo professional and technical training and job assessment, with basic theoretical knowledge and practical skills, and approved by the quality of the enterprise responsible for the operation of non-professional and technical personnel, no technical professional title shall not be engaged in drug testing work. Engaged in high biological activity, high toxicity, strong contamination, high allergenicity and special requirements of the quality of drug testing personnel, should undergo the appropriate professional technical training.
(3) staff should be regular health checkups and records. In the event that personnel are found to be suffering from diseases that adversely affect the work of the laboratory (such as infectious diseases, skin diseases, etc.), they shall be suspended from their work or transferred out.
(4) QC Laboratory should arrange training and business refresher training planning, through a variety of channels, a variety of forms, the implementation of training and assessment of personnel at all levels, focusing on the cultivation of the technical backbone, and should develop an annual plan to determine the target of training and training content. Training and assessment should be recorded
(5) quality inspection personnel files, including training materials, training certificates, certificates, academic certificates, professional skills certificates, health checkups, etc., should be unified by the personnel department archives.
Two, GMP requirements for QC laboratory software
(1) inspection quality system should be set up to involve the following aspects and documented:
A) testing process quality assurance (such as acceptance of the inspection procedures, test basis and the implementation of standard operating procedures, records and reports of the writing, checking, auditing, processing of experimental data, the issuance of the report, etc.);
B) testing environment and instrumentation quality assurance;
C) standard substances and experimental animals, experimental reagents, quality assurance;
D) technical quality assurance of inspection personnel. Quality inspection assurance system should have a clear hierarchical responsibility system to ensure the quality of the whole process of drug testing work to ensure that drug testing, standard review, new drug testing methods to establish the accuracy and reliability of the reports.
(2) QC laboratory should set up a quality supervisor, in order to receive the inspection, inspection, laboratory records, unqualified drugs or test results are in a suspicious situation when the review and processing.
(3) in order to improve the quality of testing work, to ensure the reliability of test data, QC laboratory test operations (the use of instruments and equipment, testing techniques and methods, animal experimentation procedures, reagents and liquid preparation and management, etc.) should be expressed in the form of SOPs, SOPs should be clear, clear, coherent, easy to understand, and placed on the experimental site in order to prepare for the use of the SOPs development and repair should be carried out in accordance with the prescribed procedures. Repairing should be carried out in accordance with the prescribed procedures, and should retain the original records of the development and revision
(4) new product development in the drafting of pharmaceutical quality standard analytical methods, changes in drug production methods, changes in the components of the preparation and the original analytical method for revision, or other pharmaceutical quality standard analytical methods for the use of the introduction of the introduction of the method should be carried out before the validation of the method. Before the start of validation, the validation program should be formulated for the validation object and submitted to the validation committee or other validation management body for approval and implementation. Validation content should at least include accuracy, precision, specificity, detection limit, limit of quantification, linear range and durability indicators, the implementation of the program should be strictly in accordance with the operation and carefully fill in the validation records, the validation report should be submitted to the validation committee or other validation management body to sign and approve the validation, validation programs, records (including printing of raw data, etc.) and reports should be uniformly archived.
(5) experimental reagent management system should be involved in the purchase of reagents, preparation, qualification testing, expiration date management, the use of record filling, bottle labeling content and entry and exit account management.
(6) The management of standard and control products should follow the Chinese Pharmacopoeia and the Chinese Biological Products Regulations, to formulate a corresponding management system, and a person responsible for the implementation. Incoming and outgoing records should be recorded in the account.
(7) Laboratory management system should include laboratory work system, safety system, the receipt and inspection of samples and testing and sampling system, cleaning and sterilization system, bacteriophage and cell line management system, experimental reagents and reagent and test solution and titrant quality management system, drug standard material management system, measurement management system, precision instrumentation management system, experimental animals, confidentiality system, error and accident management system. Management system, etc.
(8) the management of test records and reports, test records is the original basis for the issuance of test reports, must be written in blue and black ink or carbon pen, so that the records are original, true data, clear handwriting, complete information, the signature of the personnel should be used in the full name of the original records should be numbered according to page numbering, according to the provisions of the archives to save the contents of the contents of the leakage shall not be privatized. Inspection report is a technical appraisal of the quality of drugs, should be complete data, clear handwriting, standardized terminology, clear conclusions, and according to the specified time for long-term preservation (preserved until one year after the expiration date of the product, no expiration date of at least three years of preservation), and its format should be printed in accordance with the unified standardized model.
(9) the management of archival materials. qc laboratory should be configured with the necessary facilities to ensure the integrity and security of archival materials in order to complete all the tests will be a unified archive of the entire set of test data
(10) self-test qc laboratory should be regularly or irregularly check the implementation of the quality assurance system of the laboratories, write a record of the inspection, including the date, purpose, content, implementation, recommendations and comments, and the quality of the laboratory's quality control system, including the date, purpose, content, implementation, recommendations and comments. , implementation, recommendations and comments, the name of the inspector, etc., found that major problems should be reported in a timely manner.
Three, GMP requirements for QC laboratory hardware
(1) the size of the laboratory and the layout of the requirements
1) laboratory scale (including floor space, room function set up, etc.) should be compatible with the test function to meet the needs of the experiments, the different functions of the room and the area should be clearly identified, and at the same time should be set up for accidental lighting and alarm devices and consider a reasonable escape route. Reasonable disaster avoidance routes.
2) The laboratory should be completely separate from the production area, the environment should be clean, ventilated, bright, quiet, and away from noise, vibration and pollution sources.
3) laboratory in the following areas should be set up in the best physical separation of separate arrangements: the receipt of samples and storage area; reagents, standards of receipt and storage area; cleaning and washing area; special operations; general analysis of the experimental area; aseptic laboratories; sample observation room (including accelerated stability laboratories); data processing, data storage area; office; personnel room (locker room and rest room).
4) laboratory should be set up with the inspection of the requirements of the special or dual-use sampling room, sampling room cleanliness level should be the same as the production of material feeding area; if the sampling is not carried out in the sampling room, the sampling should be prevented from contamination and cross-pollution measures, such as the use of sampling trolleys
5) laboratory inventory area should be stored with the nature of the material such as flammable, highly toxic, corrosive, classified and so on. Compatible.
6) biological testing, microbial limit checks and radioisotope testing should be carried out in separate rooms. (
7) of dust, humidity, temperature and vibration and other special requirements of the instruments and equipment should be placed in a specialized instrument room.
8) Laboratory animal room should be strictly separated from other areas.
(2) the requirements of laboratory facilities
1) laboratory pipeline setup should be neat, there should be safety management measures and alarms, emergency and first aid facilities, for radioactive drugs, bacteriophage, vaccine testing laboratories should have the appropriate safety protection facilities.
2) should be based on the needs of experimental safety in a convenient place to set up for the accident with the eye flusher and accident showers.
3) QC aseptic operation room design requirements and sterile products in the same place of production, the use of local 100 measures, the environment should meet the requirements of class 10,000 cleanliness, while according to the needs of the test products to maintain a relative positive or negative pressure, and regular monitoring of cleanliness; access to the aseptic operation room should be a person clean and clean facilities, and set up the buffer room; the laboratory should be good lighting conditions, and have control of temperature, Humidity and other indicators of the equipment.
4) laboratory cold storage should be strictly managed, storage of goods should be partitioned and clearly marked, monitoring thermometer should be measured and certified and reasonable layout.
5) animal experiment facilities and conditions (including building facilities, environmental conditions, noise, feed, etc.) should be consistent with the requirements of the grade of laboratory animals used in the test, to meet the appropriate national standards, and in line with the special requirements of the drug testing work; drug testing of laboratory animals used in the test should have a certificate of quality, and indeed meet the quality standards set out in the certificate of conformity.
6) Instrument room should prevent static electricity, vibration, humidity or other external factors interfere with the normal use of the instrument function of the facilities; instrument power supply should be used to ensure that the voltage is constant, there is sufficient capacity, and have a good special ground.
7) sampling room should be set to prevent the spread of pollutants when the container is opened and retention of air decontamination system, with clean, sterilized sampling tools and tools to open and then closed containers, there is a container that has been sampled signs or seals.
8) have a sample room to meet the requirements of retaining samples.
9) QC laboratory should be set up "three wastes" protection and treatment devices.
10) the installation of chemical analysis of toxic gas cabinets, ventilation needs to be good, its wind speed in the open shall not be less than 0.40 and S.
(3) on the requirements of the laboratory instruments and equipment
1) QC Laboratory selection of instruments and equipment types, quantities, a variety of parameters, should be able to meet the needs of the drug testing undertaken, there are the necessary spare parts and accessories, the range, precision, accuracy of the instrument. Range, precision, accuracy and resolution can cover the requirements of the standard technical indicators of the drug being tested.
2) mandatory measurement of instruments and equipment need to be measured by the national legal unit of measurement before being put into use, and should be calibrated and labeled according to the provisions of the measurement of qualified labels.
3) precision instruments should be managed by specialized personnel, regular calibration and verification, unqualified, to be repaired, to be inspected by the instrument should have a clear status mark, and timely processing, instrument users should be qualified by the examination before operation, the use of precision instruments should be used in the registration system.
4) experimental equipment, instruments should not interfere with each other, the layout should be taken into account (such as ovens and refrigerators, centrifuges and balance should be arranged separately).
5) experimental instruments and equipment should be affixed with equipment number, validation of qualified labels and working condition mark, in order to use and management.
(4) Requirements for experimental reagents
1) Experimental reagents should be purchased, preserved and used in accordance with the requirements of the management, and according to the need for light, heat insulation and easy to use classification storage facilities.
2) Purchased and self-contained experimental reagents should be selected to meet the requirements of the container and labeled in a conspicuous place. Label content should include the reagent name, specifications or concentration, the date of purchase and manufacturers (or preparation, preparation date and preparation protocol number), expiration date, use and storage conditions, etc., and if necessary, increase the content of security; benchmark standards should be added to the standard file number, date of opening and the person in charge of the signature; titrant should also be specified in the date of calibration and the factor used.
The above is the answer of SIG Laboratory Design and Construction Company, thank you!