Management requirements for equipment in GMP purification engineering
Management requirements for equipment in GMP purification engineering
The design, selection, installation, modification and maintenance of equipment in the purification project must be in accordance with the intended purpose, and the risk of contamination, cross-contamination, confusion and errors should be minimized, and the operation, cleaning, maintenance and, if necessary, disinfection should be facilitated and sterilization; should establish...
Text label: purification engineering company, GMP pharmaceutical cleanroom engineering, equipment management requirements
GMP purification project management requirements for equipment
The design, selection, installation, modification and maintenance of equipment in the purification project must be in accordance with the intended purpose, and the risk of contamination, cross-contamination, confusion and errors should be minimized, and the operation, cleaning, maintenance and, if necessary, disinfection should be facilitated and sterilization; operating procedures for equipment use, cleaning, maintenance and repair should be established, and corresponding operation records should be kept; scales, measuring tools, instruments and meters with appropriate range and accuracy should be equipped; lubricants, coolants, etc. used in equipment No contamination of the container shall be caused, and edible grade or equivalent lubricant shall be used as much as possible; the procurement, acceptance, storage, maintenance, distribution and scrapping of production molds shall formulate corresponding operating procedures, assign special personnel to keep them, and have corresponding records; Maintenance and repair of equipment must not affect product quality.
Operation procedures for cleaning production equipment should specify specific and complete cleaning methods, cleaning equipment or tools, name and preparation method of cleaning agent, method of removing previous batch identification, and protection of cleaned equipment from The method of contamination, the longest storage period of cleaned equipment, and the method of checking the cleanliness of equipment before use, so that operators can clean all kinds of equipment in an important and effective way; The sequence and method of disassembly and assembly of the equipment, if the equipment needs to be disinfected and sterilized, the specific method of disinfection or sterilization should also be specified, and if necessary, the maximum time interval allowed between the end of the production and the cleaning of the equipment should be specified; Production equipment should be stored in clean and dry conditions; the equipment should have obvious status signs, indicating the equipment number and contents, and those without contents should be marked with a clean state; unqualified equipment should be moved out of the production and quality control area if possible , before being moved out, there should be a conspicuous status sign; the main fixed pipes should be marked with the name and flow direction of the contents. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for purification projects and GMP workshops.
Weighing instruments, measuring tools, meters, recording and control equipment and instruments for production and inspection should be calibrated and inspected regularly in accordance with the operating procedures and calibration plan, and relevant records should be kept. The calibration range should cover the use of actual production and inspection. It should ensure that the key weighing instruments, measuring instruments, meters, recording and control equipment and instruments used in production and inspection are calibrated, and the data obtained are accurate and reliable; Conspicuous signs indicating the validity period of calibration; when using automatic or electronic equipment in the process of production, packaging, and storage, calibration and inspection should be carried out regularly in accordance with operating procedures to ensure normal operation and function, and calibration and inspection should be recorded accordingly.
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SUZHOU PHARMA MACHINERY CO.,LTD. offers best-in-class products, fast delivery time, and personable, highly competent, and unparalleled services.
CUSTOM SOLUTION SERVICES is sold in oversees market and has high reputation. Besides, our products are sold with reasonable prices.
Our company specializes in manufacturing CUSTOM SOLUTION SERVICES mainly extraction machine.