We offer GMP auditing and inspections for your pharmaceutical quality systems, processes, laboratory, and supply chain. Our team of IRCA trained lead Auditors offer a flexible GXP pharmaceutical auditing solution. Helping you to improve control over quality and compliance for your organisation both internally and externally, by evaluating your suppliers, subcontractors, and service providers supporting your pharmaceutical product lifecycle
Our global team of auditors have in depth experience of conducting audits to GxP, knowledge of the pharmaceutical regulatory standards, expectations and procedures. We conduct regulatory audits in the pharmaceutical industry against the following regulatory standards; Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP), Good Clinical Practice, (GCP), and Good pharmacovigilance Practice (GVP). We also audit against IPEC guidelines for pharmaceutical excipients, ISO 15378 standards for packaging materials, and ISO 9001.
We can conduct mock inspections using our experience of the approaches taken by the major regulatory agencies and issue a report in the format you would receive from a competent authority and then assist you in addressing any observations. This will ensure you are inspection ready we also offer a wide range of training, covering inspection management, back-room logistics, hosting and how to prepare regulatory responses. We can provide both onsite and remote audits.
- Internal & External Support
- Mock Inspection
- Remediation
- Compliance Improvement Plans