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Quality and Compliance

  • Quality compliance and mamagement
  • Enviromental health and safety
HOME >Quality and Compliance
Quality and Compliance

With a professional attitude of attention to details, our commitment is to provide excellent product quality and good environmental protection and personnel safety. SciAnda (Changshu) has expanded its long-term partnership with international pharmaceutical companies by producing highly active, cytotoxic, and high potency APIs in small quantities to large-scale production with quality that conforms to international standards and with strict adherence to environmental safety and health measures. With continuous efforts to emphasize the environment, safety and health of its employees, the company has rigorously followed international and local environmental health and safety regulations.   

 

At the very beginning of the company, SciAnda declared that safety, health, and environmental protection would be among the core values of the company. These core values have already become deeply implanted in the minds of the staff, and this specific managerial core value regarding safety,health, and environment protection has now been implemented.

 

Quality complianceand management

 

SciAnda (Changshu) strictly adheres to cGMP standards regarding product quality control. The staff is required to receive formal cGMP training upon joining the company, with routinely scheduled cGMP training provided afterwards on a continuing basis. The company uses ICH Q7, which is the pharmaceutical good manufacturing practice for APIs, as instructional material for cGMP training, which combines the experiences of professionals from the pharmaceutical industry with the governmental legislative standards.This training ensures that highly potent, high quality APIs can be manufactured at this location. All facilities operated by SciAnda in China and in Taiwan conform to world standards, and well-trained staff following the strict rules cGMPs and product-specific SOPs and product specifications produces every product.      

 

Intellectualproperty compliance

 

Company products are developed in-house without infringing on the current patent rights of others. By adhering to commercial confidentiality and protection of intellectual property rights, combining strict quality assurance and quality control, and with its solid research and development and technology capabilities, SciAnda (Changshu) is able to offer opportunities for collaboration with well-known international pharmaceutical companies.

 

Responsiblecare / safety, health, and environmental protection / waste disposal

 

The Company strictly follows the rules of environmental protection and health and safety compliance in order to reduce possible liabilities and to meet customer requirements with regards to environment, health, and safety issues.

 

 

Highlights

 

US FDA Inspection.pdf

 



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SciAnda(Changshu) Pharmaceutical, Ltd.

No. 16, Dong Zhou Rd., Economic Development Zone,Changshu, Jiangsu, China 215513

TEL:86-512-5192-1000  FAX: 86-512-5192-1001 * Purchase orders, fax to 86-512-5192-1186

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