Hande’s quality system is based on ICH guidelines and follows cGMP requirements of the NMPA, FDA and EMA. We have passed several customer quality audits from 2017.
Our quality systems include the following aspects:
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Quality assurance management.
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Documentation and records.
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Personnel training and qualification.
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Material and supplier management.
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Production management.
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Laboratory management.
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Packing and labelling.
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Equipment, facility and utility management.
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Validation.
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Computerized system management.
Please feel free to contact us if you have any questions.