What we can do for you
Auditing your supplier's quality management
We dispatch our auditors to pharmaceutical plants throughout China on a weekly basis.
The audits aim at verifying compliance with the European GMP Guide, ICH Q7 and other ICH guidelines, 21 CFR Parts 210 and 211, WHO GMP, IPEC GMP, ISO 9001, etc., being aware that the audited personnel are primarily trained in Chinese GMP Guidelines.
The focus is on patient safety, including a review of genotoxicity, microbiological and particulate contamination, cross-contamination, and mix-ups.
The audited products include active pharmaceutical ingredients and their intermediates, whether produced by chemical synthesis or fermentation. Sterile ingredients and injections are another strong area. The scope of audit can also include 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, audits shared by multiple customers are the preferred method. You are invited to consult the audit library of recent reports.
A company, not a network of auditors
We are, not resellers of other auditors' reports, but people setting foot in the factories.
QLD is a Belgian entity in China, implementing ISO 9001 and ISO 19011 standards and certified for ISO 9001 compliance. The auditors are our own employees, trained both in Europe and in-house, holding individual European certification from the APIC and the European Compliance Academy.
QLD's office is in Hangzhou, about 160 km from Shanghai. You would be welcome to pay a visit to review our processes and meet our auditors. You would also be welcome to join an audit conducted on your behalf.
QLD serves over 400 clients primarily from Europe, the US, Canada, and other countries, but excluding China because it is the main area of the audits. It exclusively provides GMP/GDP audits, excelling in a single activity instead of offering multiple consultancy services.
Confidentiality is a crucial aspect of auditing. The identity, production projects, manufacturing information, and commercial relationships of all parties are protected according to strict procedures.
Our team is looking forward to working with you.
