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Highpharm ’s Quality Control department performs control analyses throughout the whole production cycle using the usual current equipments like:
:: HPLC
:: GC
:: UV
:: IR/FTIR
:: TLC
:: Potentiometric titrimeters
We can therefore ensure that all intermediates as well as the final products will meet the preset specifications. |
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The Quality Assurance department together with Quality Control, can guarantee that the production follows the proper procedures of current Good Manufacturing Practices (cGMP) to assure the highest possible quality standards
Our Quality System is based on written SOP’s, validations, change controls, deviations reports and internal audit according to cGMP.
While we are often audited by several of our multinational customers further to the periodical inspections of Health authorities, we obviously perform audits and qualifications on our critical suppliers. |
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Highpharm is a younger but professional supplier, Mainly in: APIs , Intermediates, Chemcials. Have GMP approved manufacturing base, one at Ningbo, another one at Jiangxi. Almost 30person at our R&D academy, Some products are applying for EU DMF and Japan JMF. We take "Credible, Creative, Cost-effective"
R&D- Highpharm have developped a broad experience in the management of complex multistep synthesis and become a reliable partner for the pharmaceutical industry in full compliance with its strictest standards. The synthesis of substituted hydrazines and phosgenations enable Highpharm to safety include such reactions into more conventional sequences of synthetic steps. So, Custom synthesis and contract manufacturing will be welcome always.
Quality- Highpharm has established an independent,strict and sound quality managerment system in accordance with GMP and ICH Q7A guideline, delivered by the two executive organs QA and QC. The quality control department(QC) is well equipped with state of the art instruments such as: HPLC, GC,UV,IR |
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