GMP is the World Health Organization, which is a specific requirement for the quality management system of the ownership enterprise. Nowadays, many pharmaceutical consulting companies will provide GMP consulting services, so why do GMP consulting?
Why do you need to do GMP consulting
1. Medical device manufacturers need to establish a sound quality management system to ensure that production meets requirements.
2. The production workshop should meet the corresponding GMP cleanliness requirements to meet the needs of the product production process.
3. Production raw materials, finished products, warehouses, etc. should be designed and used according to the specified storage conditions to prevent moisture, mildew, pollution and other problems.
4. Enterprises should formulate detailed production process regulations and operating procedures to ensure the standardization and standardization of the production process.
What is the relationship between design and construction during the gmp certification process?
Some enterprises in the GMP project construction or renovation design, very hard and serious, careful research, careful planning, but also to invite experts to demonstrate, but to let the medical engineering design unit identify, but often ignore the specific construction of various problems, resulting in huge waste or for the certification of the work of hidden dangers. Enterprises should pay attention to the following three issues in the specific construction work of GMP project construction or transformation: first, the construction and installation units that are familiar with pharmaceutical production and GMP requirements and have rich practical experience must be allowed to undertake the project construction tasks, reduce the unqualified rate and rework of the project, and avoid unnecessary losses and waste; Second, professional engineering and technical personnel who are proficient in pharmaceutical production technology and familiar with GMP system knowledge must be invited to supervise the construction site to eliminate possible problems or hidden dangers in the bud; Third, it is necessary to fully realize that GMP projects have special requirements for the quality of the building materials used compared with ordinary building materials, and professional and technical personnel should be sent to strictly control them"Material selection"Close. Only in this way can we ensure that the construction of the project meets the requirements and improve the overall quality of the project.
The above is an introduction to why GMP consulting should be done, which can help pharmaceutical companies save time and costs. If pharmaceutical companies want to need GMP consulting services, they can contact us in time.