Equipment Qualification

Overview

Equipment used in regulated operations must be suitable for its intended purpose and capable of performing consistently within approved operating parameters.

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

Our approach integrates User Requirements, engineering design, GMP expectations, quality risk management, process needs, calibration, maintenance, automation, and validation lifecycle principles to help clients establish and maintain equipment in a qualified state.

Our Equipment Qualification Services

Qualification Strategy Development

Development of equipment-specific qualification plans defining scope, responsibilities, critical parameters, documentation, testing requirements, and acceptance criteria.

User Requirement Specification Review

Review of URS to confirm that process, quality, safety, capacity, automation, and operational requirements are clearly defined.

Design Review

Assessment of equipment design against intended use, approved requirements, materials of construction, cleanability, maintainability, and GMP expectations.

Factory Acceptance Testing

Support for FAT planning, protocol review, functional testing, documentation verification, and assessment of equipment prior to shipment.

Site Acceptance Testing

Support for verification of equipment condition, installation interfaces, functionality, and documentation following delivery and installation.

Installation Qualification (IQ)

Verification that equipment is installed in accordance with approved drawings, technical specifications, vendor recommendations, and defined requirements.

Operational Qualification (OQ)

Testing of operating ranges, controls, alarms, interlocks, safety features, automation functions, and other critical operational parameters.

Performance Qualification (PQ)

Support for demonstrating that equipment performs consistently under routine or representative operating conditions.

Requalification

Periodic or change-driven reassessment following modification, relocation, major maintenance, software upgrade, or other significant changes.

Qualification Deviation Management

Support for documenting, investigating, assessing, and closing deviations identified during qualification activities.

Equipment We Can Support

Depending on scope, MGS can support qualification of:

• Manufacturing equipment
• Granulation equipment
• Compression machines
• Coating systems
• Blenders and mixers
• Filling and sealing machines
• Packaging equipment
• Sterilizers and autoclaves
• Depyrogenation equipment
• Lyophilizers
• Isolators and containment equipment
• Washing systems
• Cleaning equipment
• Laboratory instruments
• Stability chambers
• Cold rooms
• Refrigerators and freezers
• Material-handling systems
• Automated process equipment
• Other GxP-critical equipment

Key Qualification Considerations

MGS may assess:

• Intended use
• Equipment capacity
• Materials of construction
• Product-contact surfaces
• Cleanability
• Drainability
• Utilities
• Instrumentation
• Calibration
• Automation
• Controls and interlocks
• Alarm systems
• Safety features
• Software interfaces
• Data integrity
• Operating ranges
• Preventive maintenance
• Spare parts
• Cleaning requirements
• Containment
• Environmental interfaces
• Documentation
• Change control
• Requalification requirements

Our Approach

• Define

Understand the equipment, process, intended use, critical operating parameters, and regulatory requirements.

• Assess Risk

Identify functions and parameters that may affect product quality, process performance, safety, or compliance.

• Plan

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

• Execute

Support FAT, SAT, IQ, OQ, PQ, functional testing, calibration verification, and documentation of results.

• Resolve Deviations

Assess unexpected results or failures, determine impact, define actions, and support retesting where required.

• Report & Maintain

Prepare qualification conclusions and establish requirements for change control, maintenance, periodic review, and requalification.

Equipment Qualification Deliverables

Depending on scope, MGS can provide:

• Qualification strategy
• User Requirement Specifications
• Design review
• Risk assessment
• FAT/SAT protocols
• IQ/OQ/PQ protocols
• Test scripts
• Traceability matrix
• Calibration review
• Deviation records
• Qualification reports
• Requalification plan
• Periodic-review support
• Qualification-status tracker

Why Choose MGS

Engineering & Validation Integration

MGS combines equipment engineering knowledge with qualification, quality, GMP, and operational requirements.

Risk-Based Testing

Testing is focused on critical functions and parameters that directly affect intended use and product quality.

Practical Execution Support

Our team can support protocol development, on-site execution, deviation handling, evidence review, and closeout.

Lifecycle Perspective

Qualification is linked with maintenance, calibration, change control, periodic review, and requalification.

Inspection-Ready Documentation

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

Who We Support

MGS can provide equipment qualification support for:

• Pharmaceutical manufacturers
• API manufacturers
• Finished dosage form facilities
• Sterile manufacturing facilities
• Biopharmaceutical organizations
• Medical-device companies
• Laboratories
• High-potency and containment facilities
• Greenfield projects
• Brownfield expansions and upgrades