In a world of cut-throat competition, the only attribute that can define success for businesses/ideas is the superior quality. When it is referred to Pharma/Biotech/Cosmetics/Medical Devices industries, the quality can be defined by strong GxPs intend to implement and to follow throughout the lifecycle. Enroute, it is a challenge for Vendor Evaluation (verifying compliance of multiple vendors to select the best vendor) and Vendor Audit (verifying compliance levels of existing vendor as part of continual improvement process) in pharmaceutical organizations. To implement vendor evaluation and vendor audit process, time-critical and ever-evolving compliance requirements of manufacturing (GMP), distribution (GDP), clinical trials (GCP), laboratory (GLP (BA-BE, Clinical)) and process automation (GAMP). In such scenarios, Freyr can meticulously work with clients in vendor evaluation as well as vendor auditing process.
As part of vendor evaluation, Freyr can verify the compliance levels of multiple vendors and submits the audit reports to the clients, then clients can decide on selection of vendors, but Freyr can suggest as per client’s request.
As part of vendor audit program, Freyr can perform audit behalf of clients and manages vendor audits as per client’s vendor audit calendar and requirement.
Regulatory Audit Findings Closure
GMP, GCP, GLP (BA-BE, Clinical), GAMP, Data Centre for US (USFDA), EU, Emerging Markets
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 guidelines. While a Regulatory authority decides upon certain good practices to be followed, it is the organization that is involved in manufacturing as well as 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 suggest a potential gap in established quality management systems.
To enable organizations, align with Regulatory agencies right from the first step, Freyr provides exclusive and comprehensive GxP process establishment services, which include provision of Standard Operating Procedures (SOPs), span employee training on SOPs and best practices; and ensure effective implementation of quality management system and best practices with an end-to-end audit. Freyr can also help in vendor evaluation to select the best vendors as part of Regulatory and GMP compliance.
- Periodic GxP Compliance Audit with audit report and recommendations of closure
- Preparation of audit metrics to be presented to the management
Audit, Report, and Closure
The processes are established, SOPs defined, and the resources are trained. Are you sure that they are at their best of Regulatory adherence? 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 includes 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 audit and compliance requirements, Freyr enables organizations to be audit-ready at any given point of time. To do so, Freyr offers need-based models for audit services to ensure 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 that organizations tend to 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/ safety risks could be an expensive affair for organizations in terms of time and budget. Though these might have done during the onboarding process, there should be continuous monitoring which requires ample of time and investment from the organization.
With a complete know-how on the regional audit and validation processes, Freyr is equipped to take up the vendor management audit program and vendor management in the pharmaceutical industry in such scenarios. Freyr assists clients to perform vendor compliance audit whether the third-party entity is fit for business or not. Freyr takes care of vendor management audit program and submission of audit report, findings closure 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. 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 set standards. In such scenarios, the first thing companies should think over is, whether their internal resources are equipped enough to face health authority (HA) audits? Have they been mentored to stand the last-minute audit notifications?
With a clear-cut knowledge on 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 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 troublesome process/area for comprehensive audit is advisable.
Basing on the client’s requirements, either just an audit report or 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 Auditing
- Audit Report
- Findings Closure
- Follow Up
Regulatory Audit Findings Closure
With all the processes set, SOPs and trainings 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 their expertise to go ahead with corrective actions and documenting it for timely closures with respect to Regulatory audit report of findings.
Freyr with a cumulative 30+ years’ experience in time-critical audit and validation services, assists organizations with perfect closures right-the-first time. Freyr not only derives at a corrective and preventive action (CAPA) plan with perfect root cause analysis (RCA) but also ensures evaluating the efficiency of CAPA.
- Design CAPA Plan
- Root Cause Analysis (RCA)
- 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)