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    GuangDong King-Tech.

    GMP compliance one-stop consulting services

  • Service Field

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    API


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    Preparation

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    Biological Products

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    Laboratory

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    Cleaning Engineering

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    Automation &IT

  • Company Profile

    GuangDong KingTech Co., Ltd. was established in 2011, and locate in ZhuHai City, GuangDong Province. There are more than 30 senior engineers and consultants. There are offices in ZhuHai, ShiJiaZhuang and WuXi. The company is committed to providing automation and information system solutions, computerized system verification, quality system construction, GMP consulting and verification, project management, for pharmaceutical and related industry. Assist customers in building pharmaceutical factory facilities that meet the certification requirements of China NMPA, US FDA, EU EMEA and other relevant agencies.

  • Our Service

    One-stop service for GMP compliance based on science and risk approach

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  • Computerized System Verification
    Project Implementation
    Production information planning
  • Digital Service Platform

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    Bioreactor/Fermentor
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    Software customization
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    Smart GMP@Energy Management System
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    Smart GMP@WMS
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    Smart GMP@Process management platform(BPM)
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    Smart GMP@Engineering management system(EMS)
  • Customers And Partners

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Qualification and Validation

User Requirements Specifications (URS).

GMP design review.

VMP Validation master plan.

System impact assessment.

Design Qualification DQ.

Risk management and risk assessment.

Qualification protocol and implementation ( IQ, OQ, PQ).

Computerized system Validation

Cleaning Validation/Process Validation/Method Validation Training.

 

GMP Compliance

GMP gap analysis.
QMS quality system upgrade.
Data integrity DI management system.
GMP training.
Third party audit.
Accompanied by GMP certification inspection and audit.
Mock audit.
R&D/Technology Transfer Consulting.
GMP project management consulting.
Automation/information technology/

intelligent planning.

Contact us

 

Phone/fax:

0756-2666960.
Mobile phone: 13392961199

(Manager Sun).


E-mail:BD@bioandpharm.com


Address:

604, Block A, Yuexing Industrial Building, No. 108 Xinghua Road, Xiangzhou District, Zhuhai City.

Copyright 2019

粤ICP备2021052297号-2
    GuangDong-KingTech
    GMP compliance one-stop consulting services
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