Factory Acceptance Testing (FAT) Audits / Witnessing

Overview

Factory Acceptance Testing (FAT) is an important stage in the equipment lifecycle that helps confirm whether equipment has been manufactured, assembled, configured, and tested in accordance with approved specifications and agreed technical requirements before dispatch.

Mediature GxP Solutions Pvt. Ltd. (MGS) provides independent FAT audit and witnessing support for pharmaceutical, biopharmaceutical, API, medical-device, laboratory, and other regulated projects.

Our experts review critical equipment functions, documentation, alarms, interlocks, utilities, materials of construction, software controls, drawings, and acceptance criteria to help identify issues before equipment is shipped to the installation site.

MGS follows a structured, risk-based approach aligned with the equipment’s intended use, criticality, User Requirement Specification (URS), technical specifications, and applicable GMP expectations.

Our FAT Services

FAT Protocol Review

Review of FAT protocols to confirm that critical functions, specifications, alarms, interlocks, safety features, and acceptance criteria are adequately covered.

FAT Witnessing

Independent witnessing of agreed FAT activities at the equipment manufacturer or vendor facility.

URS Verification

Verification that equipment design and functionality align with approved User Requirement Specification requirements.

Functional Testing Review

Assessment of equipment operation, sequences, controls, alarms, interlocks, emergency functions, and critical operating parameters.

Documentation Review

Review of equipment manuals, drawings, certificates, datasheets, calibration records, material certificates, software documentation, and other agreed technical records.

Mechanical & Engineering Verification

Verification of key mechanical, electrical, instrumentation, utility, and engineering aspects against approved specifications.

Automation & Software Checks

Review of relevant HMI/PLC functions, user access, alarms, recipes, interlocks, data handling, and software features where applicable.

Deviation & Punch-Point Review

Identification and documentation of deficiencies, incomplete items, deviations, and punch points requiring resolution before equipment dispatch or installation.

Key FAT Focus Areas

Depending on the equipment and project scope, MGS may verify:

• Equipment identification and configuration
• Compliance with URS
• Approved drawings and specifications
• Materials of construction
• Product-contact parts
• Surface finish, where applicable
• Equipment dimensions and layout
• Electrical and instrumentation systems
• Utility requirements
• Control panels
• HMI / PLC functionality
• Operating sequences
• Alarms and interlocks
• Emergency-stop functions
• Safety controls
• Speed and capacity parameters
• Critical process parameters
• Recipe or parameter controls
• User-access controls
• Calibration status
• Instrument identification
• Equipment manuals
• Certificates and datasheets
• Spare-parts lists
• Preventive-maintenance requirements
• Cleaning accessibility
• Drainability and cleanability, where applicable
• Software backup
• Documentation completeness
• Open punch points
• FAT acceptance criteria

Our FAT Approach

• Understand the Equipment

Review equipment type, intended use, process criticality, URS, specifications, and project requirements.

• Review FAT Documentation

Evaluate the FAT protocol, drawings, technical specifications, and supporting documents before execution.

• Witness Testing

Observe agreed functional, mechanical, automation, safety, and performance checks at the vendor site.

• Record Observations

Document deviations, non-conformities, incomplete items, and punch points identified during testing.

• Verify Closure

Where required, review evidence of corrective action and closure of critical FAT observations before shipment.

• Report

Provide a structured FAT report summarizing testing witnessed, observations, open items, and overall status.

FAT Deliverables

Depending on scope, MGS can provide:

• FAT protocol review
• FAT witness plan
• URS verification checklist
• FAT execution support
• Independent FAT observation record
• Punch-point list
• Deviation summary
• Documentation review comments
• FAT report
• Corrective-action follow-up
• Pre-dispatch readiness review

Why Choose MGS for FAT Audits / Witnessing

Engineering & GMP Expertise

MGS combines equipment and engineering understanding with practical GMP and validation knowledge.

Independent Verification

An independent FAT witness provides objective confirmation that critical requirements have been tested before shipment.

Risk-Based Focus

Testing is prioritized according to equipment criticality, process impact, product quality, and validation requirements.

Qualification Alignment

FAT review can help ensure that equipment documentation and test evidence support later commissioning, SAT, IQ, OQ, and validation activities.

Early Issue Detection

Identifying technical or documentation gaps at the vendor site can reduce installation delays, rework, and qualification issues after delivery.

Multidisciplinary Support

MGS can involve engineering, validation, CSV, quality, and process expertise depending on the equipment and project scope.

Equipment We Can Support

MGS can provide FAT audit / witnessing support for equipment such as:

• Manufacturing equipment
• Packaging equipment
• Filling and sealing systems
• Granulation and blending equipment
• Tablet compression machines
• Coating systems
• Autoclaves
• Sterilization equipment
• Isolators and containment systems
• HVAC equipment
• Cleanroom systems
• Water-system equipment
• Utility skids
• Laboratory equipment
• Process equipment
• Automated and computerized equipment
• Other critical GxP equipment