Our QW team consists of experts and certified auditors who have worked as EU/UK Qualified personnel and IRCA-certified auditors. They can perform supplier and service provider audits according to EU GMP/GDP/MHRA/US-FDA standards.
Our auditors have a lot of experience in conducting on-site audits in Asia, Europe, the US, and the UK.
Our auditors are familiar with and can assist with the requirements for QP declaration in the UK and EU, for example.
Our auditors handle post-audit questions raised by QPs/site or regulatory inspection.
Audits of material suppliers with experience of 130+ since 2010
API – chemical synthesis, Biological process, or any extraction process
Excipients,
Packaging materials manufacturers and
Suppliers
Audits of Finished product manufacturers of with experience of 120+ since 2010
Non-sterile dosage form manufacturing, including Solid Orals (including extrusion process), Liquids and Topical Preparation
Sterile and aseptic Small molecules, Manufacturing, Nasal Spray, Ophthalmic dosage forms, Liquid and Lyophilised products
Aseptic manufacturing of large molecules, including mAbs, ATMP (Cell and Gene Therapy), Vaccine biologics and Biosimilars
Audits of Services provider with experience of 80+ since 2010
Quality control test labs, including chemical, Microbiological and Biotechnological/Biologics testing