gxp audits, consulting & inspections

With offices and compliance consultants located around the world, ProPharma offers the capability to execute audits in different GxP areas on a global scale, ensuring GxP compliance and creating efficiency and savings. Our large team of qualified auditors has a breadth of expertise across the entire development and regulatory spectrum, including the European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), United States Food and Drug Association (FDA), Japan Pharmaceuticals and Medical Devices Agency (PDMA), Health Canada, ISO-13485, ISO-9001, CAP/CLIA, Computer Systems Validation (CSV), Digital Compliance Audits, and Data Integrity.

GxP Compliance & Vendor Audits

Vendor audits are critical to maintaining GxP compliance throughout the supply chain, and ProPharma specializes in providing tailored vendor audit services that encompass a wide range of suppliers and service providers. Our expert auditors conduct thorough evaluations of suppliers' quality management practices, covering critical aspects such as manufacturing processes, quality control measures, clinical trial management, and pharmacovigilance activities. By thoroughly assessing processes, documentation practices and regulatory compliance across these service areas, we identify potential risks and areas for improvement, empowering our clients to make informed decisions in vendor selection and management. With ProPharma's comprehensive expertise, organizations can navigate vendor management complexities with confidence, ensuring GxP compliance and upholding the highest standards of quality and integrity.

Good Manufacturing Practice (GMP) Audits

Good Clinical Practice (GCP) Audits

ProPharma's GCP (Good Clinical Practice) Auditors specialize in conducting thorough and comprehensive GCP Audits, offering assurance that your clinical studies, whether ongoing or planned, are conducted in compliance with regulatory requirements. Our audits provide valuable insights and recommendations to ensure clinical study compliance success. We focus on various key areas, including:

• Clinical Research Organization (CRO)
• Investigator Sites
• Trial Master Files (TMF)
• Good Clinical Laboratory Practice (GCLP)

IT Vendor Audits

Regulators require assessment and approval for suppliers of critical software applications, IT infrastructure, and IT support services.  ProPharma has the expertise to assess system functionality and vendors’ quality management practices for compliance with regulations such as Part 11 and Annex 11. Additionally, we assess your IT vendor’s SDLC and testing methodologies so you will have the documentation to support your computer system validation strategy.  Our audit services include:

• Software, SaaS, and PaaS vendor audits
• IT infrastructure and IaaS vendor audits 
• IT service and validation provider vendor audits

Good Laboratory Practice (GLP) Audits

ProPharma specializes in conducting comprehensive GLP (Good Laboratory Practice) Audits, ensuring that pre-clinical and clinical laboratory activities are appropriately managed and comply with regulatory requirements. Our audits cover a wide range of areas, including animal studies, toxicological assessments, pharmacokinetics (PK) studies, and clinical laboratory specimen testing. Our experienced auditors identify potential areas for improvement, ensure the welfare of laboratory animals, and verify the accuracy and reliability of laboratory data. We focus on various key components of GLP auditing, including:

• Nonclinical labs
• Animal use and care

Postmarket Surveillance Audits

ProPharma’s Postmarket Surveillance Audits evaluate the intake of drug and medical device / diagnostic safety data, compliance with reporting requirements, and adherence to timelines. Our audits focus on key areas within post-market surveillance, and our team provides detailed assessments to ensure regulatory compliance and enhance patient safety. Our expertise covers the following aspects:

• Pharmacovigilance (PV)
• Complaint management
• Digital Information and Internet Systems (IT/IS)

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Inspection Readiness

Our Inspection Readiness Services Include:

1. Pre-Approval Regulatory Inspections in all GxP areas: Ensuring your organization is fully prepared for regulatory assessments
2. Mock Regulatory Inspections in all GxP Areas: Practicing simulated inspections to identify and address potential issues proactively.
3. Guidance on Corrective Actions: Providing insight into necessary corrective actions and validations before the regulatory inspection, avoiding potential non-compliance citations.
4. Training for Successful Regulatory Inspection: Preparing your team for interviews, interactions, and best practices during regulatory agency visits.
5. Inspection Readiness Reviews: Crucial, especially with the increasing frequency of unannounced inspections.
6. Compliance-Level Review for License Applications: Assessing compliance with best practice standards for obtaining or retaining essential licenses like Manufacturer's/Importation Authorisation (MIA), Wholesale Distributor Authorisation (WDA), Marketing Authorization (MA), GMP, and GDP.

Ensure your organization is inspection-ready with our comprehensive audit services, tailored to meet your GxP compliance needs and ensure seamless interactions with regulatory agencies.

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Quality Management System Gap Assessments

Providing a risk-based "right-sized" approach, our compliance experts evaluate the current state of an organization’s Quality Management System for compliance with regulatory requirements and best industry practices. Our compliance experts will seamlessly integrate with your team to do more than simply identify potential risks. We provide recommendations to mitigate those risks and can work side-by-side with you to implement improvement plans and support your staff in addressing those risks. 

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Data Integrity Gap Assessments

ProPharma assesses real-world situations vs. the principles of ALCOA to identify data integrity risks. We have drawn from international regulations, regulatory guidance documents, FDA Warning Letters, and decades of professional experience to develop comprehensive tools for assessing policies, procedures, and systems to detect data integrity risks.  Our standardized approach to performing data integrity gap assessments encompasses the requirements documented by the US FDA, EMA, MHRA, WHO, PIC/S, ISPE, and PDA.

Our mission is to provide the information you need to mitigate data integrity risks before your organization has a data integrity issue. 

Other Audit Services

Due Diligence

ProPharma's Quality & Compliance team possesses extensive expertise in conducting Due Diligence audits for firms undergoing mergers or acquisitions. These audits involve comprehensive assessments of the target companies' quality systems to evaluate their current state and provide a thorough measure of the risk associated with potential compliance faults.

Our auditors carefully examine various aspects of the target company's operations, including quality management systems, standard operating procedures, documentation practices, training programs, and regulatory compliance records. By conducting these assessments, we enable clients to gain a comprehensive understanding of the target company's compliance status, potential risks, and areas that require remediation.

We focus on identifying any compliance gaps or deficiencies that may impact the integration process. Working collaboratively with our clients, we develop effective mitigation strategies. Leveraging our expertise and attention to detail, we assist our clients in mitigating compliance risks, optimizing their due diligence process, and ensuring a seamless transition during mergers or acquisitions.

Internal Audits

Our experienced auditors can also help companies evaluate and improve their internal controls and GxP compliance. We review policies, procedures, and documentation, analyze risk management practices, and conduct interviews with key personnel. We collaborate closely with clients, offering actionable recommendations and assisting with corrective action plans. With ProPharma's expertise, organizations can strengthen their internal processes and achieve operational excellence.

Medical Device & Diagnostics

At ProPharma, we understand the unique challenges faced by medical device and diagnostic companies in maintaining compliance with regulatory requirements across different regions, including the European Medical Device Directive (MDD). Our specialized team of auditors offers comprehensive auditing services tailored specifically to the needs of medical device and diagnostic manufacturers on a global scale. 

With our global reach and expertise, we provide auditing services that encompass every aspect of medical device and diagnostic manufacturing, including design controls, manufacturing processes, quality management systems, and post-market surveillance. Our auditors are well-versed in international regulations and standards, ensuring that your products meet the necessary requirements for market approval and distribution worldwide. 

Understanding the FDA's initiative to align the QSR (21 CFR 820) more closely with ISO 13485, we stay abreast of regulatory updates and industry trends to ensure that our auditing services are always up-to-date and in line with the latest regulatory expectations. Whether you're a startup launching your first medical device or a multinational corporation expanding into new markets, our auditing services are designed to help you navigate the complexities of regulatory compliance with confidence. By partnering with ProPharma, you can ensure that your medical devices and diagnostics meet the highest standards of quality, safety, and GxP compliance, enabling you to bring innovative healthcare solutions to patients around the globe.