Chinese manufacturing.
European GMP.
We are a European GMP auditing service based in Hangzhou, China.
Our founder, Philippe André, is a Belgian pharmacist who has conducted inspections of hundreds of Asian factories since 2008. We deploy our auditors to pharmaceutical plants throughout China on a weekly basis.
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. We also take account that the personnel we interact with are primarily trained in Chinese GMP Guidelines.
Our focus is on patient safety. We review the potential for genotoxic impurities, microbiological and particulate contamination, cross-contamination, and mix-ups.
The products we audit include active pharmaceutical ingredients and their intermediates, whether produced by chemical synthesis or fermentation. We also focus on sterile ingredients and injections. Additionally, we audit regulatory starting materials, finished formulations, biological products, herbal products, excipients, primary packaging materials, distribution, and medical devices.
To minimize the cost of audits and ensure the manufacturers' full attention, we aim to organize audits that are shared by multiple customers. Most manufacturers cannot accommodate individual audits from each customer. You are invited to consult our audit library for recent reports.
Qualandre Pharmaceutical Service
Our office is in Hangzhou, Zhejiang Province, 160 km from Shanghai. You are welcome to visit, review our processes, and meet our auditors if we arrange a schedule. You would also be welcome to join an audit on your behalf.
We are a foreign-registered entity in China, following ISO 9001 and ISO 19011 standards. We hold an ISO 9001 certificate and individual certificates for our auditors.
We serve around 400 clients mainly from Europe, the US, Canada and other countries except China because it is the main area of our audits. Our sole focus is GMP/GDP audits, ensuring only one high-quality service rather than offering multiple consultancy services.
Confidentiality is crucial to us. We protect your identity, projects, and the manufacturers' confidential information. We do this by keeping in mind the purpose of GMP auditing: reporting on the quality and safety of the product and processes.
We look forward to working with you.
