Audits & Gap Assessments

LGZ Quality Services Ltd has extensive experience in audits within the Pharma and Biotech Industry and can support your business globally with:

• Good Manufacturing Practice (GMP) audits of sterile and non-sterile pharmaceutical products

• Good Distribution Practice (GDP) audits: 

              *Warehouses

              *Distribution Hubs

              *Pharma Logistics Providers   

• Vendor & Supplier on-site/remote audits (due-diligence/approval, routine, for-cause) of:

              *CMOs (e.g. API, final product)                    

              *Primary Packaging 

              *Secondary Packaging & Labelling 

              *Serialisation 

              *QC testing laboratories      

                    -Analytical

                    -Microbiological

                    -Sterility Testing

              *Excipient manufacturers                    

              *Irradiation services

              *Archive services

• Inspection readiness via:

               *Mock inspections 

               *Compliance gap assessments 

               *Internal audits/self-inspections

• ISO 9001, 11137, 15378, 13485