The world of life sciences is moving towards procedural standardization, risk-based methodology, quality by design (QbD) and common control framework. To be compliant, manufacturers of Pharmaceuticals, Biotechnology, Cosmetics, and Medical Devices must follow the geo-specific GxPs. Enroute, it is a challenge for organizations to implement time-critical and ever-evolving compliance requirements of manufacturing, distribution, clinical trials, laboratory (BA-BE, Clinical) and process automation. In such scenarios, Freyr can meticulously work with clients to easily overcome these challenges in multiple ways:
- GxP assessment and process establishment
- Performing audit for established GxP set ups and proposing multiple mitigation strategies
- Determining inspection readiness
- Performing RCA and CAPA for a Regulatory audit finding and evaluating the efficiency of CAPA for facing / submitting a Regulatory audit
- Performing target audit (Molecule /function-specific audit)
- Due diligence audit (Auditing customer’s supplier)
Freyr’s GxP audit services include:
- Good Manufacturing Practice (GMP) audit services
- cGMP audits
- GMP compliance assessment
- GMP gap analysis
- GAMP audit Services
- GxP risk assessment
- Good Laboratory Practice (GLP) audit services
- Good Clinical Practice (GCP) audit services
- Audit trail adequacy assessment
- Response to Regulatory audit report
- Audit report preparation/submission
GMP, GCP, GLP (BA-BE, Clinical), GAMP, Data Centre for US (USFDA), EU, Emerging Markets
With an in-depth knowledge on global health authority (HA) Regulatory requirements, Freyr offers specialized GxP audit services to assist Pharmaceutical, Biotechnology, and Medical devices organizations to design, develop and implement good procedural practices. By conducting compliance assessment and problem resolution, Freyr ensures compliance with geo-specific GxPs and applicable regulations that are unique and best suitable to client's Regulatory requirements
Freyr GxP Audit Expertise
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.
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 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.
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
- 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
- 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. We also organize 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.
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 preparation/submission
- Recommendations on closures
- Problem resolution
- Follow-up audit performance
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 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 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 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 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 Systems
- Root Cause Analysis (RCA)
- Evaluate the efficiency of CAPA
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
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, 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 might have done during on-boarding 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 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
Audits in general:
- Audit support (USFDA, MHRA, MHLW) for SDLC – SaaS model and On-premise model
- Audit support for all cloud application services
- Gap analysis, training, audit support for HIPAA privacy, security and omnibus – SaaS model, On-premise model and cloud application services
- GLP, esoteric testing and BA-BE analytical process set-up, gap analysis and audit support for ISO 17025, ISO 15189 and CAP accreditation standards
- Auditing suppliers (Customer’s supplier)
- GxP Audits
- Data center audit
- Data archive facilities (Paper and e-archives) audit
- SEZ unit IT/ITeS/BPO infrastructure audit for healthcare and Life Sciences business suitability
- 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