GxP Audit Services - Overview
In a world of cut-throat competition, the only attribute that can define success for businesses/ideas is superior quality. When it comes to Pharma/Biotech/Cosmetics/Medical Devices industries, quality can be defined by strong GxPs intended to be implemented and followed throughout the lifecycle. Pharmaceutical organizations find vendor evaluation (verifying compliance of multiple vendors to select the best vendor) and vendor audit (verifying compliance levels of existing vendors as part of a continual improvement process) challenging. To implement vendor evaluation and vendor GxP audit process, time-critical and ever-evolving GxP compliance requirements of manufacturing (GMP), distribution (GDP), clinical trials (GCP), laboratory (GLP (BA-BE, Clinical)), and process automation (GAMP) must be adhered to. In such scenarios, Freyr can meticulously work with clients in vendor GxP audit evaluation and vendor auditing processes.
As part of vendor evaluation, Freyr can provide GxP compliance consulting and verify the compliance levels of multiple vendors to submit the GxP audit reports to the clients. Subsequently, clients can decide on the selection of vendors upon Freyr’s advice.
As part of the vendor audit program, Freyr can perform GxP audit services on behalf of clients and manage vendor audits as per the client’s calendar and requirement.
Regulatory Audit Findings Closure
GMP, GCP, GLP (BA-BE, Clinical), GAMP, Data Centre for US (USFDA), EU, Emerging Markets
GxP Audit Services - Freyr Expertise
Compliance is a journey and not a destination. Your compliance status is as good as your defined and established processes. The system and procedures you follow to develop a drug/cosmetic/device should be aligned with established Regulatory standards and GxP guidelines. While a Regulatory Authority decides upon certain good practices to be followed, the onus lies on the organization that is involved in manufacturing, and vendors should set a procedural benchmarking to be aligned with applicable GxP regulations. We, at Freyr, notice a rise in the number of procedural standards related to non-compliance issues which suggests a potential gap in established quality management systems.
To enable organizations to align with Regulatory agencies right from the first step, Freyr provides exclusive and comprehensive GxP audit services, which include the provision of Standard Operating Procedures (SOPs), employee training on SOPs and best practices, and effective implementation of quality management systems and best practices with end-to-end GxP audit services. Freyr can also help in vendor evaluation to select the best vendors as part of Regulatory and GxP compliance consulting.
- Periodic GxP compliance audits with audit reports and recommendations of closure.
- Preparation of audit metrics to be presented to the management.
Audit, Report, and Closure
Processes are established, SOPs defined, and resources are trained. Are you sure that they adhere to GxP Regulatory compliance? Are they aligned with industry regulations and standards? Are they implementable for better compliance all through? With many questions surrounding your established systems’ capability to be compliant, it is imperative to adopt and implement vendor audit services that span across not only reporting and recommending necessary procedures but also include follow-up assistance for accurate and timely closure. We also organize GMP auditing services, vendor capability assessment, and audit-trial adequacy assessment in line with current requirements.
Being abreast with updated GxP audit and compliance requirements, Freyr enables organizations to be audit-ready at any given point in time. To do so, Freyr offers need-based models for GxP audit services to ensure the established processes are rightly aligned with industry standards on time.
Audit and Report
- GMP supplier audits.
- Vendor performance assessment.
- Compliance audit performance.
- Gap analysis checklist.
- Compliance audit report submission.
- Compliance assessment.
Audit and Closure
- Compliance audit performance.
- Compliance audit report preparation/submission.
- Recommendations on closures.
- Problem resolution.
- Follow-up audit performance.
In today’s business world, there are several instances in which organizations maintain third-party relationships to proceed with business requirements or challenges. Those could be with a supplier, distributor, or any other service provider situated away from the manufacturer. In such scenarios, vendor compliance audits of third-party manufacturing processes or facilities for environmental/operational/quality/GxP risk assessment could be expensive and time-consuming for organizations. Though these might have been done during the onboarding process, there should be continuous monitoring which requires ample time and investment from the organization.
With complete know-how on the regional audit and GxP validation process, Freyr is equipped to take up vendor management audit programs in the pharmaceutical industry in such scenarios. Freyr assists clients to perform vendor compliance audits to decide whether the third-party entity is fit for business or not. Freyr takes care of vendor management audit program and submission of audit reports, findings closures, and follow-ups if required.
The concerning factor that any pharma/cosmetic/medical device company could think of is sudden audit notifications from Health Authorities (HAs). Not being prepared to face an audit can become a last-minute challenge for organizations even when processes are established and SOPs are defined on par with global standards. In such scenarios, the first thing companies should think over is, whether their internal resources are equipped enough to face HA audits. Have they been mentored to withstand the last-minute audit notifications?
With a clear-cut knowledge of HA requirements and audit & validation industry trends, Freyr’s expert compliance team is well-positioned to understand your set procedures and mentor your internal systems to be audit-prepared even at the brink of a notification. Freyr enables organizations to perform mock audits to effectively address HA auditors.
- Enabling mock audits.
- End-to-end audit-readiness mentoring program.
Need-based audit models
There is no point in GxP compliance auditing the entire facility for a function-specific auditing notification. With clinical research programs and manufacturing activities spread across different functions, performing audits for every function prove to be costly, affecting the organization’s budgets. In such scenarios, targeting a specific process/area for a comprehensive audit is advisable.
Based on the client’s requirements in an audit report, findings closure, or follow-up, Freyr’s dedicated team chooses a specific function or department to perform comprehensive audits instead of the entire organization. Here, the scope is limited to a specific function/area to stabilize the processes.
- Function/Area/Process-specific GxP compliance auditing.
- Audit Report.
- Findings Closure.
Regulatory Audit Findings Closure
With all the processes set, SOPs and training defined, and internal audits also done, what if an auditor comes up with findings at your facility and sets a timeframe to revert with corrective actions? In such scenarios, the first thing organizations should introspect about is their expertise to go ahead with corrective actions and document it for timely closures with respect to the Regulatory audit report of findings.
Freyr, with a cumulative thirty (30)+ years of experience in time-critical GxP audit services and validation services, assists organizations with perfect closures right-the-first time. Freyr not only derives a Corrective and Preventive Action (CAPA) plan with perfect Root Cause Analysis (RCA) but also evaluates the efficiency of CAPA.
- Design CAPA Plan.
- Evaluate the efficiency of CAPA.
- Ability to manage multi-site projects in a single audit plan/one iteration
- Auditor skills (Subject Matter Expertise, Freyr being a Regulatory focussed company with auditing skills)
- Scope of the audit that covers around 20 Process areas (others cover 6 and we have converted the sub-processes of 6 process areas to 20 process areas)
- Ability to give the audit report - “Factual” as well as “Findings” (not just findings that others do)