Who we are

QLD (Qualandré) is based in China, right where many pharmaceutical ingredients are manufactured. It is a Belgian company whose registration and office are in Hangzhou, Zhejiang Province.

Our sole activity is to audit pharmaceutical good practice, like GMP, GDP, GLP, etc. This is more than enough to keep us busy! We audit sterile and non-sterile APIs, intermediates, medicinal products, injectable formulations, biological products, excipients, packaging materials, medical devices, herbal products, and distribution.

The auditing standards are the European GMP Guide, ICH Q7, 21 CFR Parts 210 and 211, WHO GMP, IPEC GMP, or ISO 9001, while taking account of guidance from the EMA, FDA, EDQM, and other authorities on topics like data integrity, change control, OOS investigations, and others.

If you don't know us yet, most manufacturers of active pharmaceutical ingredients already do.

QLD auditors are a regular fixture in Chinese pharmaceutical factories. Our founder, Philippe André, has inspected hundreds of plants in China and other Asian countries since 2008. We have since expanded our team, executing thousands of audits on behalf of more than 400 clients.

GMP Auditors

Meet our team.

Program of a GMP Audit

Focus areas on the manufacturing sites.

Sharing audits between several customers of the same manufacturer save costs and enable the manufacturer to better focus on any deficiencies.