Self inspections and supplier audits
In today’s complex environment, it can be difficult to ensure compliance to ever-changing European and national regulations. Therefore, regular audits are critical within every life science company. They provide the senior management with information about how effectively the company, its suppliers and service providers, or clients control the quality of their processes, products and capacity. Moreover, thoroughly conducted audits identify potential nonconformities to applicable requirements and ensure a timely correction thereof.
In order to maintain and support your company’s compliance level, internal and external audits must be carried out by an independent auditor on a regular basis.
Success in 3 steps
Each audit we perform has a clear scope, fine-tuned to your requirements and expectations. Understanding all applicable procedures that you (and your supplier) need to be in compliance with is a first crucial step. Next, an audit team is assembled, information gathered, an agenda agreed upon and necessary arrangements are made. All in accordance with your internal procedures and priorities/critical aspects of your suppliers.
During the audit our experts will observe, question, examine documentation and records, and challenge issues of concern to obtain evidence of compliance. Observations are recorded and concerns discussed, whilst sticking to the agreed timing.
Prior to the release of our formal report you will receive a draft for comment and verification of factual accuracy. This way we avoid any misunderstanding that may arise over observations and recommendations. The final version of the audit report chronicles all critical, major or other areas that need improvement.
If critical or major issues are identified, a new audit will be carried out within a year to ensure that all problems have been resolved.
Our experts are qualified to carry out your internal and external audits
All certified lead auditors have fulfilled a Lead Auditor Training, and are internally certified to perform audits in the following areas
Good Distribution Practice (GDP)
✓ Distribution activities under distribution license
✓ Commercial Affiliates (Sales and promotion activities only, samples distribution incl.)
✓ Re-labelling/repackaging sites
✓ Sample management
✓ Supplier qualification
✓ Medicinal Products for human and veterinary use
✓ Documentation management
✓ Provider management
✓ Supplier qualification
✓ Computerized systems validation
✓ Suppler Qualification
Good Manufacturing Practice (GMP)
✓ Finished products solid and liquid form
✓ Aseptical products
✓ Active Pharmaceutical Ingredients (API)
✓ Excipients and other raw materials
✓ GMP/GDP laboratories
✓ Supplier Qualification
Good Pharmacovigilance Practice (GVP)
✓ Pharmacovigilance systems and their quality systems
✓ Pharmacovigilance system master file (PSMF)
✓ Risk management systems
✓ Collection, management and submission of suspected adverse reactions
✓ Periodic Safety Update Report (PSUR)
✓ Signal management
✓ Safety communication
✓ Risk minimisation measures