Overview

Pharma world is moving towards procedural standardization, Risk Based Methodology, Quality by Design (QbD) and common control framework. Manufacturers of Pharmaceuticals, Biotechnology, Cosmetics, and Medical Devices must be compliant with geo-specific GxPs. Enroute, it is a challenge for organizations to keep pace in implementing time-critical ever evolving compliance requirements of manufacturing, distribution, clinical trials, laboratory (BA-BE, Clinical) and process automation. Freyr can meticulously work with you to easily overcome these challenges in multiple ways:

  • GxP process establishment
  • Performing audit for established GxP set ups and proposing multiple mitigation strategies
  • Determining your inspection readiness
  • Performing Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) for a Regulatory audit finding and Evaluating the efficiency of CAPA for facing / submitting to a Regulatory Audit
  • Performing target audit (Molecule /function-specific audit)
  • Due diligence audit (Auditing customer’s supplier)

With an in-depth knowledge on global Health Authority (HA) Regulatory requirements, Freyr offers specialized GxP audit services to assist Pharmaceutical, Biotechnology, and Medical Device organizations to design, develop and implement good procedural practices. Freyr ensures compliance with geo-specific GxPs and applicable regulations that are unique and best suitable to your company's Regulatory requirements.

Freyr GxP Audit Expertise

Process Establishment

Compliance is a journey and not a destination. Your compliance status is as good as your defined and established processes. The systems and the 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 should set a procedural benchmarking to be aligned with applicable GxP regulations. We, at Freyr, notice a raise in number of procedural standards related non-compliance issues which suggest a potential gap in established quality management systems (QMS).

To enable organizations, align with Regulatory agencies right from the first step, Freyr provides exclusive and comprehensive GxP process establishment services which includes provision of SOPs, span employee training on Standard Operation Procedures (SOPs) and best practices; and ensure effective implementation of QMS and best practices with an end-to-end audit.

Drafting / Defining SOPs

  • SOP gap analysis
  • Determining the type of SOPs needed
  • Drafting/developing and managing SOPs
  • SOP preparation and integration
  • SOP standardization
  • SOP rationalization
  • Reviewing SOPs

Training

  • Train the trainer program
  • Design a training plan
  • Training internal systems/resources on new SOPs
  • Documentation of trainings
  • Guidance on revised procedures and implementation pathways

Audit

  • 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 audit services that span across not only reporting and recommending necessary procedures, but also includes follow-up assistance for accurate and timely closure.

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.

Need-based audit models
Audit and Report

  • Compliance audit performance
  • Gap analysis checklist
  • Compliance audit report submission
  • Compliance assessment

Audit and Closure

  • Compliance audit performance
  • Compliance audit report submission
  • Recommendations on closures
  • Problem resolution
  • Follow-up audit performance
 

Audit-Readiness Mentoring

The concerning factor that any Pharma/Cosmetic/Medical Device company could think of is sudden audit notifications from HAs. Not being prepared to face an audit can become 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 equipped enough to face 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 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
 

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 is their expertise to go ahead with corrective actions and documenting it for timely closures.

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 Systems
  • Root Cause Analysis (RCA)
  • Evaluate the efficiency of CAPA
 

Target Audit

There is no point 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 client’s requirements, either just an audit report or findings closure or follow up, Freyr’s dedicated team choses 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
 

Due-Diligence Audit

In today’s business world, there are several instances in which 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, validating the third-party manufacturing processes or facilities for environmental/operational/quality/ safety risks could be an expensive affair for organizations in terms of time and budgets. Though these audits might have been done during on-boarding process, there should be continuous monitoring which requires ample amount 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 due-diligence audits in such scenarios. Freyr assists clients to perform third-party audit and evaluates whether the third-party entity is fit for business or not. Freyr takes care of audit and validation, audit report, findings closure and follow-ups if required.

  • Due diligence audit
  • Audit checklist
  • Audit report
  • Findings closure
  • Follow-up audit
 

Freyr Advantages

  • Ensuring product quality, Regulatory compliance, patient safety, data integrity and security
  • Experienced and practicing professionals
  • Integrated process models
  • Effective and compliant business processes
  • Proven validation and qualification strategies
  • Quick turnaround timeframes
  • Significant cost savings