Auditing

Zenpharm can provide audits of client or supplier facilities and operations worldwide either to obtain regulatory approval or as part of supplier management process. With our many years experience, we have gained working knowledge of operations to ensure our audits will provide insight into the true compliance of an organisation and help target areas for improvement.

Zenpharm has a proven track record of first time MHRA approval, successful remediation and ensuring continued approval for sites supported by the team.

Audits can be completed in line with required standards, including preparation of full audit report with follow up to audit close out for the following types of audit:

• Pre-approval inspections
• GMP compliance assessment prior to routine regulatory authority inspections
• Remediation - audits conducted to support site remediation requirements following regulatory action
• Quality management systems of MA Holders / MIA Holders
• API & API Intermediate Manufacturing Sites
• Excipient Manufacturers
• Finished Dosage Form - Manufacturing & Packing facilities
• Packaging Material Suppliers
• Laboratories (Chemical & Microbiology)
• Warehouse
• Transport Service Providers