QMS & Audit Support

A strong Quality Management System (QMS) is not just a regulatory requirement - it is the foundation of sustainable pharmaceutical operations

At InPharma Solutions, we help organizations design, strengthen, remediate, and defend their Quality Systems with confidence. Our approach is practical, risk-based, and inspection-focused - ensuring your QMS is not only documented but effectively implemented. We transform compliance pressure into structured quality excellence

QMS Setup & Remediation

Whether you are establishing a new facility or strengthening an existing system, a robust QMS is critical. For organizations facing regulatory observations, we conduct systematic remediation programs to rebuild system reliability and regulatory confidence. Our goal is simple, we built a QMS that works - not just one that exists on paper

We provide:

• End-to-end QMS design aligned with global GMP requirements
• Development of Quality Manual and Quality Policy
• SOP structuring across all departments
• Risk Management integration
• Data Integrity framework development
• Quality Metrics implementation
• QMS health check & remediation programs

Deviation / CAPA / Change Control

Deviation handling and CAPA effectiveness are among the most scrutinized areas during regulatory inspections. We ensure your quality events are handled scientifically, transparently, and compliantly - preventing recurrence and strengthening system maturity

We support:

• Structured deviation investigation methodology
• Root Cause Analysis (5 Why, Fishbone, Risk-based approach)
• CAPA effectiveness checks
• Change Control impact assessment
• Risk evaluation & mitigation planning
• Trend analysis & recurring deviation review
• SOP optimization for investigation robustness

Gap Assessment

Understanding your compliance gaps before regulators do is a strategic advantage. We don’t just identify gaps - we help you close them efficiently

We conduct:

• Comprehensive GMP gap assessments
• System-level and department-level evaluations
• Data Integrity audits
• Documentation gap reviews
• Facility & engineering compliance checks
• Quality culture assessment

Each gap assessment includes:

• Risk categorization
• Prioritized remediation roadmap
• Practical implementation guidance

Mock Audits

Preparation determines inspection outcomes. We prepare your team to respond confidently, accurately, and consistently during inspections. Mock audits convert anxiety into preparedness. Our mock audits simulate real regulatory inspections, including:

• Opening & closing meeting simulations
• Live documentation review
• Shop-floor interaction assessment
• Data traceability checks
• Interview readiness training
• Observation drafting exercises

Regulatory Audit Support

Regulatory inspections demand precision, transparency, and control. We provide onsite and remote support for audits from agencies such as: USFDA, WHO, EDQM, CDSCO, Other international regulatory bodies

Our support includes:

• Audit war-room coordination
• Real-time document retrieval support
• Clarification drafting
• Response strategy alignment
• Technical discussion assistance
• Observation risk analysis

Post-Audit CAPA Management

The audit may end - but compliance work continues. Our focus is on sustainable correction - not temporary fixes because the true measure of quality is how effectively you respond after an observation

We provide structured post-audit remediation including:

• Observation risk categorization
• CAPA development & justification drafting
• Timelines & implementation planning
• Evidence compilation
• Regulatory response preparation
• Effectiveness verification
• Follow-up readiness preparation