Audits & Gap Assessments

LGZ Quality Services Ltd brings extensive experience and expertise in auditing across the Biopharma, Biotech, and Pharmaceutical industries, supporting clients globally . 

At LGZ, we can support you with mock regulatory inspections where we review  your operations against current regulatory requirements, identifying gaps and strengths. We also conduct approval, for cause and routine audits which highlight any identified risks, opportunities for improvement, add value and are not just a compliance review. 

GMP Audits 

• Sterile and non‑sterile pharmaceutical products
• Manufacturing facilities and quality systems
• Support with internal audits

GDP Audits

• Warehouses
• Distribution hubs
• Pharmaceutical logistics providers

Vendor & Supplier Audits (on‑site or remote)

• CDMOs and CMOs (API and finished product across dosage forms, including lyophilised vials, tablets, capsules, ointments) for biological, biotech, pharmaceutical products, including ATMPs and biosimilars
• Primary and secondary packaging manufacturers
• Secondary packaging and labelling organisations, including serialisation
• QC testing laboratories (analytical, microbiological, sterility testing)
• Excipient manufacturers
• Irradiation service providers
• Archiving service providers

Inspection Support

• Mock regulatory inspections
• Compliance gap assessments
• Internal audits / self‑inspections

Standards Expertise

ISO 9001, ISO 11137, ISO 15378, ISO 13485, ISO 17025, PS 9000