新开药店验收流程及注意事项

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新开药店验收流程及注意事项
【中英文版】
**New Pharmacy Acceptance Process and Matters Needing Attention**
The opening of a new pharmacy involves several important steps and considerations to ensure compliance and readiness for operation.Below is a guideline outlining the acceptance process and key matters to keep in mind:
**验收流程**
新开药店验收流程是一个系统性、全面性的工作,主要包括以下几个步骤:
1.**Business License Application**
- 首先,需要向当地工商行政管理部门申请营业执照。

提交相关文件并经过审核后,领取营业执照。

- Apply for a business license first, submitting relevant documents to the local Administration for Industry and Commerce for review, and obtain the business license upon approval.
2.**Health and Quarantine Inspection**
- 接下来,须向当地卫生监督部门申请卫生许可证。

通过现场卫生审查后,方可获得许可。

- Next, apply to the local health supervision department for a health permit.Only upon passing the on-site health inspection can the permit be obtained.
3.**Drug License Application**
- 向当地食品药品监督管理局申请药品经营许可证。

提交相关材料并通过审核后,方可开展药品经营活动。

- Apply to the local Food and Drug Administration for a drug business license.Upon submitting relevant materials and passing the review, the business can commence pharmaceutical operations.
4.**Pharmacy Setup Inspection**
- 完成上述手续后,需接受药学专业技术人员对药房设置的合规性检查。

- After the above procedures, a pharmacy setup inspection by a professional pharmaceutical technician is required to ensure compliance.
5.**Final Inspection and Acceptance**
- 所有准备工作完成后,进行最终验收。

包括设施设备检查、药品质量检查等。

- After all preparations are completed, a final inspection and acceptance should take place, including checks on facilities and equipment, as well as drug quality.
**注意事项**
在验收过程中,以下几点是需要特别注意的:
1.**Documentation Accuracy**
- 确保所有文件齐全、准确无误。

任何遗漏或错误都可能导致验收不通过。

- Ensure all documents are complete and accurate.Any omissions
or errors may result in failure to pass the acceptance.
2.**Compliance with Regulations**
- 严格遵守相关法律法规。

药店需符合药品经营质量管理规范(GSP)的要求。

- Strictly adhere to relevant regulations.The pharmacy must comply with Good Supply Practice (GSP) requirements for pharmaceutical operations.
3.**Quality of Drugs**
- 药品质量必须得到保证。

不得经营假冒伪劣药品,确保消费者用药安全。

- The quality of drugs must be guaranteed.Counterfeit or substandard drugs should not be sold to ensure consumer safety.
4.**Professional Staff**
- 配备合格的药学专业技术人员。

他们应具备相应的资质和经验,以提供专业的服务。

- Equip with qualified pharmaceutical professionals.They should possess the necessary qualifications and experience to provide professional services.
5.**Patient Safety**
- 注重患者隐私和安全。

确保药品的储存、销售等环节符合安全规范。

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