3rd Party Audits
Conducting supplier and service provider audits is a key requirement under the GMP rules and guidelines. A certificate from a supplier or service provider for critical products is not enough on its own. Qualification is required, and this can include an audit directly on site that must be repeated at regular intervals. When these audits are conducted by an independent 3rd party, being able to absolutely rely on the quality of performance is essential.
Ensuring compliance along the entire relevant supply chain, nationally and internationally, is always the goal.
3rd Party Audits – the Full Bandwidth
From a comprehensive qualification audit to a routine compliance or follow-up audit – what counts is the in-depth technical expertise of the auditor and absolutely secure knowledge of the respective, relevant rules. Here gempex enjoys the full trust of its customers with business relationships that have lasted for many years.
Local Expertise – in Europe and Asia
Audits are conducted by qualified gempex auditors. They have a broad range of practical experience and expert knowledge of the applicable regulations. A presence directly on site is a special advantage – gempex has sites in Germany, Switzerland and China. Audits are conducted from these sites with local expertise. And low travel costs. Including the corresponding follow-ups if desired. This ensures continuous compliance for customers.
Proven Tools, Standardised Methods, Reliable Quality
Proven tools are used for 3rd-party audits of suppliers, contract manufacturers, external laboratories and service providers conducted by gempex. These range from the audit agenda to the audit questionnaire to highly developed audit checklists. The entire process follows an audit SOP in compliance with regulations. Flexibility in responding to specific wishes and customer requirements is assured. Reliable quality and diligent auditing are guaranteed.
Detailed Audit Reports with Clearly Identified Deviations and CAPA Measures
Great emphasis is placed on carefully prepared and detailed audit reports. Findings are documented precisely. CAPA measures are requested from the audited firm on this basis. The proposed measures are reviewed by experts. A clear, verified list of measures concludes the audit. GMP compliance through competent expert reviews.
Benefits
- qualification of service providers and suppliers by experienced experts
- ultimate quality of performance: gempex has been qualified itself by customers numerous times
- security and permanent relief for the customer
- clearly defined approach, fixed audit processes
- overcoming cultural barriers through regional experts in Europe and Asia
- detailed audit reports with concrete starting points and scheduled CAPA measures
- ensuring the implementation of CAPA measures in the course of follow-ups