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On-site inspection of pharmaceutical GMP certification is an important part of the entire GMP certification process. As an important part of the quality control system, QC (Quality Control) laboratory has always been one of the key points in the implementation of enterprise quality management. VWR HPLC vialsThe inspection work must comply with the requirements of the GMP regulations of the drug, and the QC laboratory's GMP certification on-site inspection should be done. First, it is necessary to understand the requirements and inspection points of the GMP for the QC laboratory.
1 Scale and layout of the laboratory
The laboratory scale (including building area, room function settings, etc.) should be adapted to the requirements of the inspection function to meet the needs of each experiment. The laboratory is generally composed of physical and chemical laboratory (dark room), standard solution room, balance room, biological performance laboratory, instrument room (package inspection room, high temperature heating room), chemical reagent library, sample observation room, laboratory animal room, file Room, dressing room, office, etc. The bioassay and microbial limit test shall be carried out in separate rooms. The experimental animal room shall be strictly separated from other areas, and its design and construction shall comply with relevant national regulations. Instruments and instruments with special requirements shall be placed in a special instrument room and have facilities to prevent static electricity, vibration, humidity or other external factors. Each room shall be equipped with a temperature and humidity meter.
2 Laboratory inspection facilities
The laboratory should be equipped with appropriate testing equipment according to the functional requirements. General requirements are equipped with electronic balance, high performance liquid chromatography, gas chromatograph, ultraviolet spectrophotometer, moisture analyzer, potentiometric titrator, dissolution apparatus, oven, biochemical incubator, accelerated tester, sterilizer, general package Facilities such as material detectors.
3 Laboratory checkpoints
3.1 Physical and chemical laboratory
The physical and chemical laboratories are mainly to check whether they have the facilities and instruments that are compatible with the production varieties.
Physical and chemical laboratories should first have basic experimental facilities, such as experimental consoles, fume hoods, scrubbing tanks, test racks, glassware drying cabinets or brackets, pipettes or graduated straw holders, as well as necessary ventilation facilities. And dark facilities. The experimental console should be non-slip, acid and alkali resistant, easy to clean and have a certain buffering effect, and it is not easy to cause the glass container to be broken. There should be no power outlets or switches in the ventilated kitchen. Explosion-proof motors and switches should also be provided for the use of organic solvents. The washing pool should be resistant to acid and alkali.
Secondly, it is necessary to check the calibration of the glass measuring instruments. The glass measuring instruments that need to be regularly verified mainly include pipetting tubes, graduated straws, measuring bottles, measuring and measuring cylinders, and the like. In the on-site inspection, the number of one measuring instrument should be randomly checked and the corresponding verification record should be checked. Check the preparation and storage of the chemical test solution again. The preparation of the chemical test solution can select several kinds of chemical test liquids involved in a certain experimental link to check whether the preparation meets the requirements. When checking, first check whether the labeling method and content are correct and complete, and whether the container filled with the test solution meets the requirements. For example, the silver nitrate test solution should be stored in the brown thin mouth test liquid bottle, and the sodium hydroxide solution should be stored in the glass with the rubber stopper. In a bottle or plastic bottle.
3.2 Standard solution chamber VWR HPLC vials
Checking the standard solution chamber is mainly to check the configuration, calibration, storage and use of the titration solution corresponding to the production variety. The indoor temperature and humidity should meet the specified temperature of 15?25, the relative humidity is 45.-65%, and should be equipped with corresponding temperature control and dehumidification facilities (such as air conditioners, moisture absorbers). At the same time, the titration solution should be configured according to the storage requirements of the titration solution. Storage cabinet; the corresponding burette should be configured according to the test variety. Alkaline titration solution (such as sodium hydroxide titration solution) should use alkali burette, and titration solution (such as silver nitrate titration solution) to avoid light operation should use brown burette, burette Should be verified and within the validity period; the preparation and calibration of the titration solution should meet the requirements (such as sodium thiosulfate titration should be calibrated after preparation and storage for 1 month). The preparation record should be complete (such as the original titration data constant weight process record) Etc.) The concentration or its value to be calibrated should meet the requirements. The records of the toxic chemical reagents involved and the records used should be complete. The storage of the titrant should be in accordance with the storage conditions.
3.3 Balance room
The balance chamber should be away from the source to prevent air and magnetic interference. The platform should be strong and shockproof, with suitable height and width. The room should be dry and bright and protected from light. Temperature and humidity control facilities or equipment with a temperature of 15-25 and a relative humidity of 45-65%. To check whether the accuracy and quantity of the balance meet the requirements of the test, whether it is equipped with a special balance for weighing 10,000 tons of toxic chemicals; whether the accuracy of the sample and the precision of the test are “weighed according to the Chinese Pharmacopoeia” "Measurement", "precision weighing", etc. for weighing, such as "precision weighing" means that the quality taken should be accurate to one thousandth; whether there is a balance usage record, whether the usage record is complete; whether the balance is regularly verified and Paste the calibration mark on the obvious part of the balance, whether to maintain and maintain the balance according to the regulations, whether there is maintenance, maintenance and maintenance records of the balance. When checking the balance usage record, you can select a test item, compare it with the test sample and chemical reagent used from the head symmetry quantity to check whether the record is true and complete; when checking the balance maintenance and maintenance, check the balance after use. Whether it is closed, whether the inside of the balance is clean and tidy, and whether the desiccant is discolored.
3.4 Biological Performance Laboratory
The biological performance laboratory consists of a preparation room, an operation room and an auxiliary room. The operating room should generally include a sterile examination room, a microbial limit examination room and a positive control room, a bioassay room, a bacterial endotoxin test room (no aseptic processing conditions are required), an insoluble particle test room VWR HPLC vials(the most easily overlooked sterile room) . Positive control rooms require straight rows. Check whether the design of the operation room meets the requirements, whether the delivery and return air system are reasonable, whether the interior of the operation room is simple and free of impurities, easy to clean and disinfect; whether the sterilizer pressure gauge in the preparation room is valid, before sterilization and after sterilization Whether the items are stored separately, whether the sterilized items indicate the expiration date; whether the preparation and use records of the medium are complete, whether the preparation quantity is consistent with the used quantity, and whether the storage conditions meet the requirements. The auxiliary room mainly stores the incubator and the refrigerator. It should be checked whether it has a biochemical incubator. The incubator indicates whether the temperature is consistent with the culture requirements, whether the culture is registered, whether there is a culture record, such as the prepared medium should be 2 25, protected from light, stored in a non-closed container should be used within 3 weeks, stored in a closed container should be used within 1 year, the strain used should not exceed 5 generations, passaging, inactivation should be recorded, sterility test should be After 14 days of cultivation, pay attention to the sampling amount of the test sample. The sterilizing and microbiological examination should increase the number of inspections by the membrane filtration method, and the inspection amount should be no less than the total amount of the direct inoculation method.
3.5 Instrument room
QC laboratory selects the type, quantity and various parameters of instruments and equipment to meet the needs of the drug inspection, and necessary spare parts and accessories.
The range, precision, accuracy and resolution of the instrument can cover the requirements of the standard technical indicators of the tested drug. Mandatory measuring instruments and equipment shall be put into use after being inspected by the national legal metrological unit, and shall be regularly verified and labeled with the qualified label. Precision instruments should be managed by special personnel, regularly verified and verified. The instruments that are unqualified and inspected should have obvious status marks and be processed in time. There are instrumentation records, maintenance, maintenance, and maintenance records, with obvious equipment numbers, verification conformance labels, and work status flags. The user of the instrument shall pass the examination and the use of the precision instrument shall have a registration system for use. When multiple instruments are stored together, they should not affect each other. The air exhaust device must be installed according to the operation requirements of the instrument. In addition, the oven and high temperature furnace should be stored in a high temperature heating chamber, and the distance from the wall should not be less than 15cm.
3.6 Chemical Reagent Library VWR HPLC vials
The chemical reagent library should have good ventilation facilities. Common chemical reagents and toxic chemical reagents should be stored separately and have storage temperature and humidity requirements. Toxic chemical reagents should be stored in double locks for counters and establish strict inbound and outbound records. The reference standard reagents should be stored according to the regulations, and should be managed by a person, and the use and preparation should be recorded. Locations with temperature storage requirements should have temperature and wet records. If there is a validity period, it should be used within the validity period. Chemical reagents should be used at different levels and not too much. The import chemical reagents at the chromatographic level generally do not indicate the expiration date, and the date of activation should be indicated on the label.
3.7 Sample observation room
The sample observation room mainly has a room temperature observation observation room, a cool sample retention observation room, and a frozen (refrigerated) sample retention observation room. The temperature indication of the sample observation room should be consistent with the product storage requirements, and the temperature record should be true, timely and complete. The sample retention observation is divided into ordinary sample retention and key retention samples. The quantity and time of sample retention should meet the requirements. The sample observation project should be reasonable, and the records should be complete and regularly analyzed and reported.
3.8 Laboratory Animal Room
The experimental animal room must hold the test animal use permit, and purchase the animal from the licensed (laboratory animal production license) experimental animal breeding unit; the newly purchased experimental animal must pass the quarantine to enter the breeding room; the experimental animal feeding and experiment Cleaning, VWR HPLC vials disinfection, waste, and breeding rooms should be separated and a corresponding account should be established.