Periodic Review & Requalification

Overview

Qualification does not end after initial approval. Facilities, utilities, equipment, and systems must continue to perform reliably and remain in a controlled state throughout routine operation.

Mediature GxP Solutions Pvt. Ltd. (MGS) supports pharmaceutical, biopharmaceutical, API, medical-device, laboratory, and other regulated organizations with periodic review, requalification planning, change-impact assessment, documentation review, execution support, and lifecycle maintenance.

Our approach considers system performance, maintenance history, calibration status, deviations, change controls, alarms, failures, environmental or process trends, previous qualification results, and current intended use to determine whether continued qualification status is adequately supported.

Our Periodic Review & Requalification Services

Periodic Review Strategy

Development of risk-based periodic-review programs defining review frequency, system categorization, responsibilities, documentation requirements, and escalation criteria.

Qualification Status Review

Assessment of whether facilities, utilities, equipment, and systems continue to meet approved requirements and remain within a qualified state.

Change Impact Assessment

Evaluation of modifications, upgrades, relocations, software changes, process changes, component replacement, or other changes that may affect qualification status.

Requalification Planning

Development of requalification scope based on system criticality, performance history, change impact, regulatory expectations, and identified risks.

Performance History Review

Evaluation of deviations, alarms, breakdowns, maintenance, calibration, monitoring data, failures, CAPA, and operational performance.

Documentation Review

Assessment of qualification records, SOPs, drawings, calibration status, preventive-maintenance records, change controls, and supporting technical documentation.

Requalification Protocol Development

Preparation or review of protocols defining tests, acceptance criteria, responsibilities, and evidence required to reconfirm system performance.

Requalification Execution Support

Support for field testing, documentation, deviation handling, result review, and qualification closeout.

When Requalification May Be Required

Depending on risk and applicable requirements, requalification may be considered following:

• Significant equipment modification
• Facility renovation
• HVAC modification
• Utility-system change
• Equipment relocation
• Major maintenance
• Critical component replacement
• Software or control-system upgrade
• Repeated deviations or failures
• Out-of-trend performance
• Extended shutdown
• Change in intended use
• Change in operating range
• Process modification
• Periodic qualification review
• Regulatory or quality-system remediation

Key Periodic Review Areas

MGS may review:

• Qualification status
• System criticality
• Current intended use
• Change-control history
• Deviation history
• CAPA
• Preventive maintenance
• Breakdown history
• Calibration records
• Alarm history
• Environmental trends
• Utility trends
• Process-performance data
• Equipment performance
• Cleaning status, where applicable
• Software or automation changes
• SOP revisions
• Training status
• Previous qualification deviations
• Outstanding actions
• Regulatory or audit observations

Our Approach

• Identify

Define systems requiring periodic review and establish review frequency based on risk and criticality.

• Collect

Gather qualification records, change controls, maintenance data, calibration history, deviations, monitoring trends, and other relevant lifecycle information.

• Assess

Evaluate whether system performance, documentation, and changes could affect the validated or qualified state.

• Determine Action

Conclude whether continued qualification is supported or whether partial or full requalification is required.

• Execute

Where necessary, develop and support requalification protocols, testing, deviation handling, and documentation.

• Report & Track

Document conclusions, actions, qualification status, due dates, and future review requirements.

Deliverables

Depending on scope, MGS can provide:

• Periodic-review procedure
• Periodic-review schedule
• System criticality assessment
• Periodic-review checklist
• Qualification status assessment
• Change-impact assessment
• Requalification strategy
• Requalification protocols
• Execution support
• Deviation assessment
• Periodic-review report
• Requalification report
• Action tracker
• Qualification status tracker
• Future review schedule

Why Choose MGS

Risk-Based Lifecycle Approach

MGS focuses review and requalification effort according to system criticality, performance history, and actual risk.

Integrated Data Review

Our approach considers qualification, maintenance, calibration, deviations, changes, monitoring, and operational performance together.

Practical Requalification Strategy

Not every change requires complete requalification. MGS helps define an appropriate and justified scope based on impact and risk.

Cross-Functional Expertise

Our team can integrate engineering, validation, quality, manufacturing, laboratory, CSV, and maintenance perspectives.

Controlled-State Focus

The objective is not only to complete periodic documentation, but to demonstrate that the system continues to remain fit for intended use.

Who We Support

MGS can provide periodic-review and requalification support for:

• Pharmaceutical manufacturing facilities
• API facilities
• Biopharmaceutical organizations
• Medical-device companies
• Laboratories
• HVAC and cleanrooms
• Utility systems
• Manufacturing equipment
• Laboratory equipment
• Containment systems
• Existing facilities
• Facilities undergoing modification, expansion, or remediation