Qualandre Pharmaceutical Services.
European Good Manufacturing Practice Audits of Pharmaceutical Plants in China.
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Chinese manufacturing. European GMP.
European Good Manufacturing Practice Audits of Pharmaceutical Plants in China.
View Details
Qualandre Pharmaceutical Services.
European Good Manufacturing Practice Audits of Pharmaceutical Plants in China.
View DetailsAbout Us
Chinese manufacturing.
European GMP.
We are a European GMP auditing service based in Hangzhou, China.
We audit sterile and non-sterile APIs, intermediates, medicinal products, injectable formulations, biological products, excipients, packaging materials, medical devices, herbal products, and distribution.
Our standards are the European GMP Guide, ICH Q7 and other ICH guidelines, 21 CFR Parts 210 and 211, WHO GMP, IPEC GMP, ISO 9001, and guidance provided by the EMA, FDA, EDQM, and other authorities on data integrity, change control, OOS investigations, and other topics.
View More →Our founder, Philippe André, is a Belgian pharmacist who has inspected hundreds of Asian factories since 2008.
Beyond GMP compliance, we review the potential for genotoxic impurities, microbiological contamination, particulates, cross-contaminants, etc.
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View More →Audit Library
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We offer shared audits with other customers of the same manufacturer to cut costs and allow the manufacturer to better accommodate and address deficiencies.
Auditing is expensive due to planning, auditor fees, travel expenses, report reviews, and follow-ups. By sharing costs, we can provide competitive pricing and high-quality service.
Your API supplier might have many customers like you, and would be glad to have all those audits requests bundled into one.
Audits can of course be conducted exclusively, too.
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