Vendor Management and Audit services
Here at Orion Consulting we have built a strong team of GXP audit professionals with decades of experience in GMP, GDP and GVP audits and inspections which can be carried out globally.
Our dedicated pool of auditors have experience in a wide range of dosage forms and processes, medical devices, API, Excipient, laboratories, storage sites and service providers. Each auditor is selected according to their expertise and experience and is assessed for suitability before engaging in a client audit. We also have experience in managing bespoke audit requirements to assess technology transfer capabilities or to carry out an initial assessment of sites to GMP, GLP, GCP and GDP regulations.
For each project, we work with our clients to discuss their individual needs, review the company or site to be audited and determine the capabilities to be assessed and regulatory standards to be applied. If an on-site evaluation is required, we will work with our client to ensure the audit is booked and to identify the best auditor for the type of assessment.
The initial assessment of a new critical supplier or facility to determine if the quality management system is adequate and the site capable of manufacturing or storing the product to be supplied may require in-depth multi-day onsite audits. Our clients and their QPs/RPs will need to get a feel for the general levels of housekeeping, cleanliness, and maintenance. Our clients can depend on us to determine if the facility is well designed and laid out and has the capacity to manufacture or hold the volumes required to GMDP standards. For follow-up or routine audits of suppliers initially deemed GMP/GDP compliant (with minimal observations from the initial assessment) we can also assist with virtual audits. The most essential tool in determining what type of audit to complete is the periodic audit risk assessment. We can assess the risks associated with individual new suppliers and use this to determine if an onsite audit or virtual audit should be added to the audit program.
Following all the above careful preparation steps, we conduct the audit, assess the site capabilities and draft our findings which are shared at the closing meeting. We then follow up after 2 weeks with a formal report as well as one further review to assess CAPA actions and give final recommendations.
Orion GXP Consulting has a panel of highly experienced auditors with many decades of GxP, laboratory, and facility assessment experience. We can work closely to identify the right expert for your audit requirements, whether supplier assessments, storage sites, testing laboratories or internal or external manufacturing sites.
If you need an immediate assessment of your audit program or have a critical or urgent audit that you need to address then, please contact us at info@oriongxp.com
