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According to the requirements of the drug administration, the required information will be ready, ready, and then use the software that meets the requirements of the new GSP to sort out the data, and there will be no problem when checking.
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Summary. Hello dear, I am glad to answer this question for you, what materials are needed for drug GSP certification? 1) A copy of the Drug Business License and the business license;
2) The self-inspection report of the implementation of GSP by the enterprise; (C) the enterprise responsible personnel and quality management personnel table; Table 4) Facilities and equipment such as business premises, warehousing, acceptance, and maintenance of enterprises; (5) The information table of the drug business unit to which the enterprise belongs; (6) Catalogue of the enterprise drug business quality management document system; (7) The establishment and functional block diagram of the enterprise management organization; (8) The floor plan of the enterprise's business premises and warehouse, and (9) the description of the enterprise's sale of fake and inferior drugs not due to violations of laws and regulations. I hope mine is helpful to you, and I wish you a happy family and all the best!
What materials are required for GSP certification of drugs?
Hello dear, I am glad to answer this question for you, what materials are needed for drug GSP certification? 1) A copy of the Drug Business License and the business license; 2) The self-inspection report of the implementation of GSP by the enterprise; (C) the enterprise responsible personnel and quality management personnel table; Table 4) Facilities and equipment such as business premises, warehousing, acceptance, and maintenance of enterprises; (5) The information table of the drug business unit to which the enterprise belongs; (6) Catalogue of the enterprise drug business quality management document system; (7) The establishment and functional block diagram of the enterprise management organization; (8) The floor plan of the enterprise's business premises and warehouse, and (9) the description of the enterprise's sale of fake and inferior drugs not due to violations of laws and regulations. I hope mine is helpful to you, and I wish you a happy family and all the best!
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There is still a lot of information provided by the GSP certification of pharmacies, I think 80% of the workload is to sort out the information, I don't know if you are talking about human drugs or veterinary drugs, but the information generally provided is similar.
According to the provincial GSP requirements, prepare the information that needs to be submitted.
A set of veterinary drug GSP management system according to the GSP on-site evaluation standards (in accordance with the provincial veterinary drug GSP requirements, very targeted).
According to the veterinary drug GSP management system, a set of veterinary drug GSP records** (must be matched).
A set of sample forms that need to be filled out with a record** (provide a sample form, you will see it at a glance).
GSP requires the required learning and training materials (the GSP jury takes it very seriously, and you can see how to deal with it during the judging process).
Various wall systems and their associated signs and labels (set up with computer drawing software).
About 10 folders that have been bought and labeled (the materials are classified and numbered, so that they are easy to learn and understand).
If you need the above services, you can ask me for help, and I wish you success in passing the GSP certification of veterinary drugs.
In addition, in addition to doing a good job of information to be reviewed, it is necessary to renovate the warehouse and business premises, which have some things to be on the wall, if it is a veterinary drug GSP, the content of the wall required by the veterinary drug GSP is:
1. Various main responsibilities.
2. The enterprise or neck organization can only be drawn.
3. Service Convention.
4. Quality commitment and supervision.
5. Some special requirements of the local veterinary drug GSP management department (generally very little).
I have prepared the above information, all set up with computer drawing software, I not only provide these information, but also provide a variety of signs and labels, such as those sub-qualified areas, unqualified areas, return veterinary drug areas, veterinary drug areas to be tested, etc.
If you need help, just come to me, it's hard to explain the specific process.
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Guangdong Province Veterinary Drug GSP Inspection and Acceptance Application Materials Catalog.
Serial number Name of application materials New veterinary drug enterprises and units Reconstruction and expansion of veterinary drug enterprises and units.
1 "Application for GSP Inspection and Acceptance of Veterinary Drugs in Guangdong Province" +
2. The self-inspection report of the enterprise according to the "Guangdong Province Veterinary Drug GSP Inspection and Acceptance Evaluation Standards" +
3 Enterprise organization chart, enterprise quality management organization setting and function chart +
4 List of personnel in the enterprise +
5 Business premises, warehouses, acceptance and maintenance and other facilities and equipment of the enterprise +
6 Unincorporated Branches to which the Enterprise Belongs +
7 Schematic diagram of the location and internal layout of the business premises and warehouses of the enterprise +
8 Enterprise veterinary drug management quality management system +
9 Catalogue of types and varieties of veterinary drugs operated by enterprises +
10 Copy of the Notice of Pre-approval of Business Name +
11. Copy of "Veterinary Drug Business License" and business license
Note: 1"+ indicates the materials that must be submitted; 2." indicates that materials that do not need to be submitted.
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2. The self-inspection report of the enterprise according to the "GSP Inspection and Acceptance Evaluation Standards" +
3 Enterprise organization chart, enterprise quality management organization setting and function chart +
4 List of personnel in the enterprise +
5 Business premises, warehouses, acceptance and maintenance and other facilities and equipment of the enterprise +
6 Unincorporated Branches to which the Enterprise Belongs +
7 Schematic diagram of the location and internal layout of the business premises and warehouses of the enterprise +
8 Enterprise veterinary drug management quality management system +
9 Catalogue of types and varieties of veterinary drugs operated by enterprises +
10 Copy of the Notice of Pre-approval of Business Name +
11. A copy of the Pharmaceutical Business License and the business license.
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In front of us just had an introduction to the pharmacy GSP certification.
If you want to get pharmacy GSP certification, there are still a lot of materials to prepare, and it is also very important and indispensable. For example, when we apply for GSP certification of pharmacies, we should prepare an application form for GSP certification, and some should have a copy of the original and duplicate of the drug business license and the business license. If we want to get the GSP certification of the pharmacy, we must have the quality inspection report of the pharmacy company, and the explanation of some problems of the company's non-illegal distribution of fake and inferior drugs, and also consider the assessment of the person in charge and the quality management personnel.
There is also the need for pharmacy personnel to report on drug acceptance and maintenance personnel. It is also necessary to assess the applicant's professional and technical title certificates and academic certificates for quality management personnel, drug acceptance, and maintenance personnel, as well as the employment contract of the person in charge of quality.
After going through these steps, you can apply for the pharmacy GSP certificate, are you ready to open a store? If you meet the above requirements, you can apply for GSP certification at the pharmacy. I hope you succeed.
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There are two types of situations in which a retail pharmacy can apply for GSP certification. In the first case, single pharmacies, including directly operated stores of drug wholesale enterprises and newly opened retail chain stores after August 1, 2008, shall directly apply for GSP certification to the district drug administration branch of the administrative jurisdiction where the pharmacy is located, and shall submit the following 7 kinds of information: (1) GSP certification application; (2) Copies of "Drug Business License" and "Business License" (GSP certification and roster of certified stores that have passed GSP certification); (3) The self-inspection report of the implementation of GSP by the enterprise (the chain store shall be reported by the chain company); (4) The person in charge of the enterprise, quality management personnel (resident pharmacists), acceptance personnel, and salesmen; (5) Enterprise facilities and equipment; (6) Catalogue of quality management systems for enterprise drug business; (7) Floor plan of the business premises and warehouse (not required for chain stores).
All the above application materials are bound into a book on A4 paper and submitted in triplicate to the drug regulatory window of the administrative examination and approval hall of the district** for acceptance. Generally, the place where the district drug regulatory department accepts it is in the government affairs hall of the district. You can go directly to the district drug administration and ask.
The second situation is that pharmacies applying for recertification and pharmacies that have not been certified by retail chain stores opened before August 1, 2008 shall be applied for GSP certification by the chain company to the Municipal Food and Drug Administration, and the application materials are the same as the above requirements.
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Search on the Internet for "Retail Pharmacy GSP Certification (Renewal) Full Set of Materials** Pharmacy GSP Certification Application Materials Demonstration Text GSP Certification Declaration Sample", I believe you will get a complete answer.
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First go to the online declaration, and then prepare the materials to go to the Food and Drug Administration for declaration.
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