GSP Certification Consulting Services


For the hospital preparation room, the GSP specification of drugs runs through the whole process and all aspects of pharmaceutical production management. Fuzhou Famo Youke Machinery Technology Co., Ltd. is a professional preparation room overall solution service provider. For hospital preparation drugs, it can strictly follow the relevant provisions of the "Drug Business Quality Management Standard" (GSP), and provide full-process verification services for drug storage equipment facilities and temperature and humidity automatic monitoring systems. Fuzhou Famo Yoko Machinery Technology Co., Ltd. provides you with comprehensive GSP certification consulting services. The services include:

(I). Contract negotiation:

1. Introduce and understand each other on the phone;

2, further discussion of intention, must require an interview;

3, determine the terms of the contract, sign the contract;

 

(II). Develop a work plan:

1. To conduct a comprehensive review of the existing situation of the enterprise;

2, according to the audit report, formulate the corresponding work plan;

3. Determine the project leaders and project staff of all parties;

 

(III), training:

1. Training on regulations and GSP specifications;

2. All kinds of management training;

3. Explain the work plan so that all departments can clearly define their work and responsibilities;

4. Further training in the preparation process of GSP certification;

 

(IV), software construction:

1, according to the actual situation of the enterprise for the enterprise to prepare all management software in line with GSP requirements;

2, according to the actual situation of the enterprise to write all operating software and records in line with GSP requirements;

3, if the enterprise itself to develop operational documents and health, the consultant to review;

4. Guide enterprises to conduct verification and simulation operations;

5. Guide enterprises to establish and improve all kinds of archives;

6. Guide enterprises to fill in all kinds of records;

 

(V), hardware transformation:

1, guide enterprises to adjust the warehouse and improve all kinds of facilities;

2. Guide enterprises to improve the temperature and humidity monitoring system;

3, guide enterprises to configure cold storage (if necessary);

4. Guide enterprises to configure the necessary computer facilities.

 

(VI), GSP certification simulation inspection

1, guide enterprises to complete the preparation of GSP declaration materials and by the consultant to review and check.

2, by the consulting company to organize the simulation inspection.

3, the unqualified items to rectify, maintain the operation of the quality system

 

(VII), submit GSP certification declaration materials, and obtain the data acceptance number.

 

(VIII), meet the food and drug administration GSP certification on-site inspection.

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