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| An Oral Care Products Manufacturer |
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Industry: Food & Healthcare Devices |
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The Client is a Hong Kong manufacturer of oral care products.
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The Client planned to establish a new manufacturing plant in Guangdong for different lines of oral care products. |
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The products were classified as medical devices by the United States FDA and had to comply with Quality System Regulation (QSR) based on the current Good Manufacturing Practice (cGMP) before they could be sold in the US. |
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The manufacturer had no knowledge of the requirements for medical devices to comply with the QSR. |
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| HKPC's Services/Solutions |
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As project consultant, HKPC assisted the Client in designing a new factory based on the cGMP requirements, as well as establishing and implementing a manufacturing quality system in accordance with the QSR and other US FDA regulatory requirements for medical devices. |
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HKPC provided guidance to the manufacturer in factory hardware design to fulfill the requirements of cGMP. |
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HKPC provided guidance to the Client in establishing and implementing the cGMP system, and integrating it with the ISO9001:2000 Quality Management System. |
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| Productivity Achievements |
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The client was able to satify the US FDA regulatory requirements for their products to be sold in the US. |
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The manufacturer successfully established the cGMP system, which helped them to secure a contract from a major US client for the manufacturing of different lines of medical products.
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