GxP Audits for Compliance and Quality Assurance.
Ensure the quality and safety of your products throughout the development, commercialization and post marketing process with comprehensive GxP audits.
GxP (Good X Practice) refers to a set of regulations and guidelines governing various aspects of the pharmaceutical lifecycle. GxP audits assess a third party’s (e.g., CROs, CMOs, laboratories) compliance with these critical standards, mitigating risks and ensuring patient safety.
Auditing takes a significant amount of time throughout every phase of the pharmaceutical lifecycle and requires significant technical expertise for full assessment of third parties, vendors, suppliers or consultants’ processes, procedures and expertise during the audit. Auditors need not only technical expertise, but also auditing expertise and the right personality so that they can ensure the time with the third party being audited is maximized and as insightful as possible, given the short amount of time provided.
During early development phases, audits of Contract Research Organizations (CROs) and other third parties engaged at this critical time, ensure that strategic development partners can deliver on their commitments whilst reducing the development cost and time to market.
Having a partner who can centralize all auditing needs and coordinate these into a risk based optimized audit strategy and execute the program with high quality resources can significantly save time and money for companies at any stage in the product lifecycle.
Our team of experienced GxP auditors provide a comprehensive range of services, including:
- Good Laboratory Practice (GLP) Audits: Ensure the reliability and integrity of non-clinical study data.
GLP audits ensure all non-clinical activities are performed according to the applicable regulations and data generated is integral and can be used to support the later phases in the product lifecycle. - Good Clinical Practice (GCP) Audits: Safeguard the integrity of clinical trials and patient well-being.
GCP audits are essential to safeguard patients enrolled in clinical studies and ensure that all clinical sites are compliant with the relevant clinical trial regulations, ethics and the clinical protocol agreed with the appropriate regulatory authorities.
- Good Clinical Laboratory Practice (GCLP) Audits: Provide assurance that laboratories engaged in testing of samples from clinical studies, do so in a compliant manner and again safeguard the integrity of the data that will eventually be used to support a Marketing Authorization (MA)
- Good Manufacturing Practice (GMP) Audits: Verify that manufacturing processes meet stringent quality and safety standards.
GMP audits must be undertaken by technically competent auditors who understand manufacturing platforms, the equipment required, the automation that drives the process in addition to supporting departments such as Quality Control, Facilities, Engineering and Maintenance. Finding an auditor with the right mix of experience and auditing ability, particularly for aseptic, innovative and novel manufacturing process and in the right geographical location is not always and easy task without a company like Arriello to provide appropriate auditors or to support overall supplier or vendor audit programs, providing an end-to-end solution for this resource heavy program of work.
- Good Distribution Practice (GDP) Audits: Maintain product quality and integrity throughout the supply chain.
GDP audits require auditors with deep experience in the distribution of a wide variety of medicinal products in addition to the automated systems used to support chain of custody and recall. Supply chains for medicinal products cross geographical territories and thus are subject to a wide variety of local, national and centralized regulations. Auditors need to be versed in the regulations in each territory in which they perform audits whilst still assessing each auditee in the context of the overall supply chain for the product. This is an area that can be effectively supported by Arriello, providing the right expert auditors in the right location at the right time.
- Good Pharmacovigilance Practice (GVP) Audits: Evaluate the effectiveness of your pharmacovigilance program.
Clinical Safety and pharmacovigilance programs are often outsourced to service providers like Arriello that can provide both global and local Pharmacovigilance support. These providers must also be audited to ensure their compliance with Good Pharmacovigilance
Benefits of partnering with Arriello for GxP audits:
- Deep industry expertise: Our auditors possess a thorough understanding of GxP regulations and relevant industry practices.
- Global reach / local knowledge: We offer audits worldwide, ensuring seamless support regardless of your supplier location.
- Scalable solutions: We adapt our services to meet your specific needs, from single audits to ongoing audit program management.
Ready to ensure your pharmaceutical operations meet the highest GxP standards?
Contact Arriello today for a no-obligation consultation.
What our clients say about us.
Arriello has been truly committed to meeting our needs and providing us with guidance and recommendations along every step of way. We have now been using Arriello for approximately five years and are extremely satisfied with our choice.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.
