Quality Management of Biopharmaceutical Workshop Projects: A Solid Defense for Drug Safety
创建于06.11
In the field of biopharmaceuticals, the quality of workshop projects is directly related to drug safety and efficacy. Guangzhou Cleanroom Construction Co., Ltd. has been deeply engaged in the industry, using professional capabilities to build a solid foundation for quality management of biopharmaceutical workshop projects and providing escort for pharmaceutical production.
I. Overall Layout of Quality Management Process
(I) Control Preparation: Plan Before Acting
Data collection is the foundation. Comprehensively sort out the regulatory standards, design drawings, equipment parameters, etc. involved in the biopharmaceutical workshop project to ensure that quality control is based on regulations. Develop exclusive control plans, and clarify quality objectives and control points in combination with the special requirements of biopharmaceuticals for cleanliness, sterile environment, etc. Establish a quality management system, from personnel responsibilities to operation specifications, to build a strict quality assurance network. Carry out control disclosures to make every person involved in the project clear about the quality standards and their own responsibilities, and gather quality consensus.
(II) Before Construction: Multi - Dimensional Pre - control
Pre - control of personnel, materials, and equipment comes first. Screen personnel with experience in biopharmaceutical workshop construction, conduct professional training to improve quality awareness and practical operation skills; strictly check materials and equipment, from basic materials such as air ducts to purification equipment, to ensure that they meet the quality requirements of cleanliness and sterility in biopharmaceuticals. Technical pre - control focuses on key points. For complex technical links such as the purification technology and pipeline layout of the biopharmaceutical workshop, organize expert demonstrations to optimize the construction technology plan. Plan pre - control refines the process, and detailedly plans the construction process and quality inspection nodes to build a solid framework for construction. Environmental pre - control cannot be ignored. Plan measures for cleaning, dust prevention, etc. of the construction environment in advance to avoid construction pollution affecting the subsequent cleanliness of the workshop.
(III) During Construction: Dynamic Quality Protection
Quality inspection runs through the whole process. Adopt the combination of patrol inspection and special inspection, and strictly inspect key processes such as air duct processing, installation, and purification equipment commissioning. Once deviations are found, rectify them immediately. Regularly hold quality meetings, bring together construction parties, supervision parties, and our technical personnel, report quality conditions, discuss and solve construction problems, and gather the joint force of quality control. Establish a defect management mechanism, timely record and track quality hazards and construction loopholes until closed - loop solutions are achieved. Simultaneously do a good job in data management, accurately record construction quality data and rectification situations, and provide strong support for quality traceability and subsequent acceptance.
(IV) Completion Stage: Build the Last Line of Defense
Self - acceptance is strict and meticulous. According to the quality standards of the biopharmaceutical workshop, verify key indicators such as air duct air leakage volume test and cleanliness detection one by one to ensure that the project quality meets the standards. Actively cooperate with external acceptance, such as acceptance by the drug supervision department and the customer. Sort out data in advance and rectify problems to ensure the smooth progress of acceptance. Completion delivery pays attention to details, do a good job in project data handover, operation training, etc., so that biopharmaceutical enterprises can receive and put into production smoothly with peace of mind. At the same time, continuously improve data collection to retain complete data for subsequent project review and quality improvement.
II. Strong Execution in Quality Control Process - Taking Air Duct Project as an Example
In the biopharmaceutical workshop, the air duct system is crucial for creating a clean environment. The company has built a strict quality control chain around the air duct project:Air Duct Processing Inspection: Strictly control the blanking accuracy and notch quality to ensure that the air duct is formed regularly and lay a foundation for subsequent quality.Air Duct Cleaning Inspection: Follow the cleanliness requirements of biopharmaceuticals, adopt professional cleaning processes to remove oil stains and impurities, and check the cleanliness of the inner wall of the air duct after cleaning to avoid polluting the air flow.Air Duct Gluing Inspection: Pay attention to the uniformity and tightness of the sealant to prevent air leakage from affecting the cleanliness of the workshop. Inspect the gluing quality section by section to build a solid sealing line of defense.Finished Air Duct Acceptance on Delivery: Check and verify the specifications, quantity, and re - measure the dimensional deviation. Combined with light leakage detection, check the air duct for damage and leakage points to prevent unqualified air ducts from entering the construction link.Air Duct Air Leakage Volume Test: As a key acceptance item, simulate the operating conditions of the biopharmaceutical workshop, accurately detect the air leakage of the air duct, and ensure the stable delivery of clean air flow.
Taking a glimpse of the air duct project, Guangzhou Cleanroom Construction Co., Ltd. has created a reliable quality foundation for biopharmaceutical workshop projects with full - process and strong - execution quality management. In the future, the company will continue to deeply engage in the industry, keep up with the development of the biopharmaceutical industry, iterate the quality management model, contribute more to safeguarding drug quality safety and promoting the high - quality development of the pharmaceutical industry, and make every biopharmaceutical workshop a solid fortress for drug safety.
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