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GxP Audit Services
Here at Orion Consulting we have built a strong team of GxP audit professionals with decades of experience in GMP inspections of global active pharmaceutical ingredients and finished dose manufacturing sites including in Asia and other emerging markets. 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. |
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Selecting the type of audit
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 assist by assessing the risks associated with individual new suppliers and using this to determine if an onsite audit or virtual audit should be added to the audit program.
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 assist by assessing the risks associated with individual new suppliers and using this to determine if an onsite audit or virtual audit should be added to the audit program.
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Tools and audit planning
For each assessment, we work with our clients to discuss their individual needs, review the company or site to be assessed 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. For in-person or virtual audits, it is critical to plan for success and ensure the site to be audited will have the appropriate equipment and adequate broadband/Wi-Fi availability to allow the assessment to be successful. It is also essential to verify with the site to ensure that SOP’s, records, data and other documentation is inspection ready can be shared with the auditor either by hard copy or using a secure data sharing program. |
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Audit Completion
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 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@orionconsulting.ie |
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