Commissioning & Qualification

Overview

Commissioning and Qualification (C&Q) provides documented evidence that critical facilities, utilities, equipment, and systems have been designed, installed, tested, and operated in accordance with approved requirements and intended use.

Mediature GxP Solutions Pvt. Ltd. (MGS) supports pharmaceutical, biopharmaceutical, API, medical-device, laboratory, and other regulated organizations with commissioning and qualification planning, protocol development, execution support, deviation management, documentation review, and final qualification reporting.

Our approach integrates engineering, GMP, quality risk management, validation, documentation, and operational requirements to help clients achieve reliable system startup and maintain a controlled state.

Our Commissioning & Qualification Services

C&Q Strategy Development

Development of project-specific commissioning and qualification strategies defining scope, responsibilities, system boundaries, documentation requirements, and execution methodology.

User Requirement Review

Review of User Requirement Specifications to ensure critical process, quality, engineering, safety, and operational requirements are clearly defined.

Design Review & Qualification Support

Assessment of system design against approved requirements, intended use, GMP expectations, and qualification needs.

Commissioning Support

Support for pre-startup checks, installation verification, functional testing, vendor documentation review, system balancing, and engineering verification.

Installation Qualification (IQ)

Verification that equipment, utilities, and systems are installed in accordance with approved drawings, specifications, manufacturer recommendations, and design requirements.

Operational Qualification (OQ)

Verification that systems operate as intended across defined operating ranges, alarms, controls, interlocks, and critical functions.

Performance Qualification (PQ)

Support for demonstrating consistent system or equipment performance under routine or representative operating conditions.

FAT & SAT Support

Support for Factory Acceptance Testing and Site Acceptance Testing to verify equipment and system functionality before and after installation.

Qualification Deviation Management

Assessment, documentation, investigation, and closure support for deviations identified during commissioning and qualification.

Qualification Reporting

Preparation or review of qualification reports summarizing executed tests, deviations, acceptance criteria, results, and final qualification status.

Key Systems We Support

Depending on the project, MGS can support C&Q activities for:

• Manufacturing equipment
• Packaging equipment
• HVAC systems
• Cleanrooms
• Purified water systems
• Clean steam systems
• Compressed air systems
• Process gases
• Chillers and cooling systems
• Boilers and steam systems
• Electrical systems
• Building Management Systems
• Environmental Monitoring Systems
• Laboratory equipment
• Warehousing systems
• Containment systems
• Other GxP-critical utilities and equipment

Our C&Q Approach

• Define

Understand the system, intended use, critical requirements, project scope, regulatory expectations, and qualification objectives.

• Assess Risk

Identify critical functions, quality attributes, failure modes, and areas requiring focused qualification testing.

• Plan

Develop the qualification strategy, protocols, test requirements, acceptance criteria, responsibilities, and execution sequence.

• Execute

Perform or support commissioning checks, IQ, OQ, PQ, FAT/SAT, functional testing, and documentation of results.

• Resolve Deviations

Evaluate failures or unexpected results and ensure appropriate investigation, corrective actions, and retesting where required.

• Report & Release

Compile and review qualification evidence and confirm readiness for approved use or transition to the next lifecycle stage.

C&Q Deliverables

Depending on scope, MGS can provide:

• C&Q strategy
• User Requirement Specifications
• Design review
• Risk assessments
• FAT/SAT protocols
• Commissioning checklists
• IQ/OQ/PQ protocols
• Test scripts
• Traceability matrix
• Deviation records
• Qualification summary reports
• System handover documentation
• Qualification-status tracker
• Requalification recommendations

Why Choose MGS

Engineering & Qualification Integration

MGS combines engineering understanding with validation and GMP requirements, improving alignment between design, installation, and qualification.

Risk-Based Testing

Qualification effort is focused on critical functions and risks rather than unnecessary testing.

Practical Execution Support

Our team can support documentation development, field execution, deviation handling, evidence review, and closeout.

Lifecycle Perspective

C&Q activities are structured to support future operation, maintenance, change control, periodic review, and requalification.

Inspection-Ready Documentation

MGS focuses on clear, traceable, and evidence-based qualification records suitable for audit and inspection review.

Who We Support

MGS can provide commissioning and qualification support for:

• Pharmaceutical manufacturing facilities
• API facilities
• Finished dosage form plants
• Sterile manufacturing facilities
• Biopharmaceutical facilities
• Medical-device facilities
• Laboratories
• Utility systems
• HVAC and cleanrooms
• High-potency and containment facilities
• Greenfield projects
• Brownfield expansions and upgrades