GMP Audit & Simulated Inspection
The need for a third-party audit of GMP
It is a third-party compliance assurance organization, which, in combination with cGMP regulations and appendix requirements, as well as relevant national laws and regulations, systematically audits and evaluates the quality management system of the entrusted enterprise, reviews its authenticity, correctness, compliance, legality and traceability, and issues a GMP audit report. According to the audit report, the enterprise rectifies the deficiencies and defects in R & D, production and operation to ensure the stable and compliant operation of its quality management system.
Scope of GMP Third Party Audit
API manufacturers |
Preparation manufacturer |
Pharmaceutical packaging material manufacturers |
Contract manufacturers, external laboratories and service providers, etc. |
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GMP third-party audit service process
GMP third-party audit experts:
Durst advantage:
1: Have a complete set of problems found, respond to official opinions, formulate rectification measures, guide the implementation of rectification measures, and follow up the effectiveness of the implementation of rectification measures to solve all problems found, and finally successfully pass the audit and official inspection service system
2: professional team, a number of well-known foreign experts to join the industry, rich experience in auditing. Has conducted GMP audits for a number of companies
3: Location advantage. Durst has offices in East China, South China and Southwest China, which is more convenient for face-to-face communication and investigation with enterprises..
4: one-stop, all-round technical services, etc.
Durst Success Story (partial):
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Yangzijiang Pharmaceutical Group Nanjing Hailing Pharmaceutical Co., Ltd. |
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Shenzhen Zhonghe Hyderway Biotechnology Co., Ltd. |
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North Hunan Wellman Pharmaceutical Co., Ltd. |
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Shanxi Nuocheng Pharmaceutical Co., Ltd. |
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Shenzhen Haibin Pharmaceutical Co., Ltd |
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Anshi Pharmaceutical (Zhongshan) Co., Ltd. |
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Zhongshan Wanhan Pharmaceutical Co., Ltd. |
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Unnamed Biological Group |
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Zhejiang Jingwei Pharmaceutical Co., Ltd. ...... |
Contact Information
Durst (Shenzhen) Consulting Service Co., Ltd.
Contact Phone:86-18826007039
E-mail:consulting@delsalt.com
Address: C19, Building 1, Yongheyuan, Zhuangbian Community, xixiang street, Bao 'an District, Shenzhen City, Guangdong Province
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