GMP evaluation of manufacturing sites of pharmaceutical ingredients, medicinal products and medical devices
Who we are:
Qualandre is a team of Belgian and Chinese GMP auditors based in China. Our main office is in Hangzhou, about 160 km away from Shanghai. GMP audits are our sole activity.
We are qualified for audits of active pharmaceutical substances, excipients, medicinal products and medical devices.
Feel free to request our qualification documents: audits@qualandre.com
Our procedures: We initiate each audit project according to customer requests. We propose it to potentially interested companies. We determine its price according to the number of interested customers, which can then confirm their order if they agree on the price. To protect the commercial information of our customers, no participant is informed of the identity of the other participants. After issuance of the report, we request a plan of corrective action from the auditee, which we follow up. The customers receive updates as we receive them from the auditee. Each audit report contains a summary, a recommendation, a list of non-conformities, as well as detailed observations on quality management, personnel training, facilities, equipment, materials management, production management, packaging, and laboratory controls. For each subsection, a list of areas visited and document reviewed is provided. The focus of each audit depend on the circumstances. In case of multi-product equipment, for example, cross-contamination control, including, but not limited to, cleaning validation will be attentively reviewed. For fermentation products, the microbiological purity of the broths would be another focus area. For all products, the protection of analytical data integrity is reviewed, etc. |