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System Management
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SYSTEM MANAGEMENT(QC/QA+HES SYSTEM )

We can accomplish mostly analysis items on organic synthesis field.
The instrument of BLOOM TECH are made of 3 parts: R&D center, cooperation manufactories and colleges. 

 

Our GMP factories have individual QA unit and QC unit, according to GMP requirement under the guideline of ICH Q7. Our QC test center covers 1500m2, including quality and chemical analytical lab, instrument analytical lab and microbial test lab. Many precious analytical instruments such as NMR, XRD, LC/MS, GC/MS, MALVERN Mastersizer2000, SEM, HPLC, and GC. etc are all Our GMP factoriesll-equipped.

 

A complete documentation system for all kinds of SOP is on site, and quality management regulations such as change control, deviation management, validation, calibration, self-inspection and quality review are strictly performed. From process design, material purchase, production, test and release to after-sale service, Our GMP factories practice overall process control, so as to ensure stable and high quality.

 

Our GMP factories have passed on-site GMP inspection by CFDA, US-FDA, PMDA, MFDS and BGV-Hamburg Germany, etc. Our major products have been granted many International certifications such as USFDA-EIR LETTER, CEP and EU-GMP certificate, etc.

HES SYSTEM

 Safe production policy
Safety first, prevention first, all hands, comprehensive management, risk management as the basis, the implementation of PDCA cycle management model, to create a team cooperation, employee cooperation safety environment, and ensure safety in production.

 

Environmental policy
Pollution control, emission control, continuous improvement, energy conservation, all hands, and environmental protection.

 

Standardization of safety production
Companies in accordance with the "hazardous chemicals practitioners safety standards for general purpose" (AQ3013-2008) requirements, comprehensive safety work standardization work. Through the establishment of safe production responsibility system, safety management system and operating rules, investigation and management of risks and monitoring of major hazard source, regulate the production of behavior, and continue to improve, continue to strengthen the standardization construction of safety in production enterprises. Company in 2011 through security standards, two standard enterprises acceptance, and in 2014 through security standards, two standard enterprises review.

 

 Emergency drill
The company has formulated a scientific, practical and targeted emergency response plan for production safety, set up an emergency fire brigade and signed an emergency rescue agreement with the county fire brigade, which has been continuously improved through regular exercises.

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Tel: +86-029-87385578   |  Address: Block A of Central Mansion, No.113 of Weiyang Rd, ETDZ, Xi'an, Shaanxi 710016, China  |  Email: sales@bloomtechz.com

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