Pharmaceutical Quality Risk Management (QRM)

Pharmaceutical Quality Risk Management (QRM) Consultancy Services

Embedding ICH Q9 (R1) Principles to Drive Compliance, Efficiency, and Product Quality Throughout the Lifecycle

1. Our Mission & Alignment

We specialize in implementing pragmatic, process-based Quality Risk Management that goes beyond audit readiness. Our mission is to help you embed ICH Q9 (R1) principles into your daily operations, transforming QRM from a documentation exercise into a strategic tool for:

• Proactive Compliance: Exceeding regulatory expectations (FDA, EMA, PMDA, etc.).

• Enhanced Patient Safety: Ensuring risks to product quality and availability are proactively controlled.

• Operational Excellence: Focusing resources on critical parameters, reducing batch failures, deviations, and costly over-control.

• Accelerated Development & Launch: De-risking CMC strategies, tech transfer, and regulatory submissions.

2. Core Service Pillars (ICH Q9 Focused)

A. QRM Foundation & Governance

• QRM System Maturity Assessment: Benchmarking your current QRM practices against ICH Q9 (R1) principles and regulatory expectations.

• QRM Policy & Procedure Development: Crafting (or remediating) SOPs that define roles, responsibilities, processes, and documentation requirements aligned with ICH Q9.

• Risk-Based Decision-Making Culture: Facilitating training and workshops for leadership, QA, and technical staff to move from a reactive to a proactive, risk-based mindset.

B. Risk Assessment & Methodology Application

• Facilitation of Formal Risk Assessments: Expert facilitation of key cross-functional teams using structured tools:

  • FMEA/FMECA (Failure Mode Effects Analysis): For equipment, processes, and analytical methods.

  • HACCP (Hazard Analysis Critical Control Points): For sterile manufacturing, process validation, and packaging.

  • FTA (Fault Tree Analysis): For complex system failures or investigation root cause.

  • PHA (Preliminary Hazard Analysis): For early development and new technology introduction.

• Criticality & Impact Assessments: Defining Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) through systematic risk assessment (link to ICH Q8/QbD).

C. Lifecycle-Focused QRM Applications

• Development & CMC:

  • De-risking formulation and process development using QbD principles.

  • Risk-based justification of specification and stability protocols.

• Tech Transfer & Scale-Up:

  • Comparative risk assessment (sending vs. receiving site).

  • Risk-based validation strategy (ICH Q8/Q9/Q10 triad).

• Commercial Manufacturing:

  • Risk-Based Change Management: Prioritizing and defining change action plans based on risk.

  • Risk-Based Vendor Management: Quality agreements and oversight strategy for CMOs and critical suppliers.

  • Risk-Based Periodic Review: For processes, products, and the QMS itself.

• Supply Chain & Distribution:

  • Risk assessment for cold chain, shipping, and anti-counterfeiting strategies.

  • FMEA for packaging and labeling processes.

D. Integration with Pharmaceutical Quality System (PQS - ICH Q10)

• Management Review Input: Designing risk-based metrics and dashboards for executive oversight.

• Deviation & Investigation: Using risk assessment to prioritize investigations, define CAPA scope, and determine product impact (similar to ICH Q9's "Risk to Quality" section).

• Audit & Inspection Strategy: Deploying audit resources based on risk profiles of systems and sites.

• Training Effectiveness: Applying risk to define and prioritize GMP training requirements.

E. Proactive Risk Review & Communication

• Risk Register Development & Maintenance: Creating a dynamic, site-wide or product-specific risk register that is regularly reviewed and updated.

• Risk Communication Tools: Developing visual risk dashboards (heat maps) and clear summary reports for management and regulatory agencies.

• Preparing for Regulatory Interaction: Supporting the justification of risk-based decisions in regulatory filings (IND, IMPD, NDA, MAA) and during inspections.

3. Our Engagement Model (Tailored to Pharma)

1. Discovery & Scoping (Diagnostic): GAP analysis of your QRM system against ICH Q9 (R1).

2. Strategy & Plan: Co-development of a project charter with defined deliverables, timelines, and cross-functional team structure.

3. Execution & Facilitation: We act as subject matter expert facilitators. We guide your team through the process, ensuring ownership remains with you. This includes:

   • Pre-workshop data gathering.

   • Leading risk assessment sessions (FMEA, etc.).

   • Drafting risk assessment reports and summaries.

4. Implementation & Integration: Assisting with the rollout of risk-based decisions into SOPs, batch records, validation protocols, and change controls.

5. Monitoring & Sustainment (Optional): Periodic reviews to ensure the QRM process remains alive and effective.

4. Key Deliverables (Pharma-Specific)

• QRM System Maturity Report & Roadmap

• ICH Q9-Aligned QRM Master Plan or SOP

• Formal Risk Assessment Reports (e.g., FMEA for Fill-Finish Line, PHA for New Biologic Process)

• Prioritized Site/Product Risk Register with Visual Heat Maps

• Risk-Based Justification Documents for regulatory strategies or internal governance

• Training Modules & Workshop Materials on practical QRM application

• Risk-Based Audit Plan or Vendor Management Strategy

5. Client Sectors Within Pharma/Bio

• Biotech Start-ups & Virtual Companies: Building a compliant, risk-based QMS from the ground up.

• Established Pharma: Maturity advancement and remediation of QRM processes.

• Contract Manufacturing Organizations (CMOs/CDMOs): Enhancing client-facing QRM and tech transfer capabilities.

• API & Excipient Manufacturers: Applying QRM to chemical synthesis and raw material control.

• Cell & Gene Therapy/Advanced Therapies: Novel modality risk assessment where standards are evolving.

6. Why We Are Your Ideal QRM Partner

• Regulator-Savvy Expertise: Our consultants have deep experience with FDA, EMA, and other health authorities on QRM expectations. We speak the language of both ICH and the inspector.

• "In the Room" Experience: We have personally led and defended risk assessments during major GMP inspections and pre-approval inspections (PAIs).

• Focus on Sustainability: We don't create shelf-ware. We build your team's internal capability to own and run the QRM process independently.

• End-to-End Lifecycle Knowledge: From pre-clinical CMC to post-marketing commitments, we understand how risk evolves across the product lifecycle.