Dust Extraction System Validation Overview

Introduction to Dust Extraction System Validation in Oral Solid Dosage Manufacturing

In the manufacturing of oral solid dosage forms—such as tablets and capsules—effective dust control is a fundamental requirement for maintaining product quality, personnel safety, and preventing cross-contamination. Dust extraction systems, also known as dust collectors or containment systems, serve a critical function in controlling airborne particulates generated during blending, granulation, compression, coating, and packaging processes. These systems keep the environment compliant with current Good Manufacturing Practice (GMP) expectations while supporting robust occupational health and safety standards.

Validating a dust extraction system ensures that it performs as intended and consistently controls airborne dust within upper acceptable limits. The scope, risk profile, and GMP expectations for this equipment differ from other utilities, requiring specific attention during qualification phases.

Role and Intended Use of Dust Extraction Systems

A dust extraction system is engineered to capture, contain, and remove dust particles generated from various process steps in oral solid dosage (OSD) areas. It typically comprises extraction hoods, ductwork, filtration units (e.g., HEPA or bag filters), fans/blowers, and sometimes integrated monitoring or alarm features. The primary intentions of this equipment are:

• Preventing cross-contamination between different product streams.
• Protecting operators from inhalable pharmaceutical particulates.
• Containing hazardous, potent, or allergenic APIs (Active Pharmaceutical Ingredients).
• Maintaining production environments within defined cleanliness and airflow standards.
• Ensuring product quality by reducing particulate-related defects or risks.

Intended Use Boundaries

• Designed solely for airborne nuisance or hazardous dust—does not control vapors, solvents, or biological hazards.
• Protection focus: process areas involving direct material handling (e.g., transfer, sieving, compression).
• Not a substitute for full cleanroom HVAC but serves as an engineering control within the room.
• Not suitable for explosive dust without ATEX or NFPA-compliant design and validation.
• Should not be relied upon for environmental monitoring; dedicated systems cover this aspect.

Validation and Qualification Scope

For dust extraction system validation, a clear scope is essential. The in-scope elements are those that affect GMP compliance, product quality, operator safety, or data records. Items typically out of scope include non-GMP areas and building HVAC unless they directly interface with the process extraction zone.

In-Scope Elements

• Extraction equipment installed in or servicing GMP production areas.
• Process interfaces: hoods, points of capture, and connection points to process equipment.
• Filtration systems (primary, secondary, HEPA) and filter monitoring/alarm mechanisms.
• Instrumentation related to flow, pressure, and operational status alarms.
• Control systems and critical data recording devices.
• System components subject to maintenance controls (filters, fans, ductwork).

Out-of-Scope Elements

• Extraction for non-GMP support or utility areas.
• Air conditioning or comfort cooling unrelated to containment.
• Building management system elements unless controlling GMP-relevant features.
• Portable cleaning or housekeeping vacuum units not dedicated to process areas.
• Explosion-protection systems unless required by risk assessment for combustible dust.

Criticality Assessment

Assessing the criticality of dust extraction systems is fundamental to determine the extent and rigor of qualification required. The following points summarize key risk areas:

• Product Impact: Ineffective dust capture may lead to product cross-contamination and compromise batch purity.
• Patient Risk: Cross-contaminated products can pose life-threatening risks, especially with potent APIs or allergens.
• Data Integrity Impact: Inadequate monitoring or recording of filter status/alarms may obscure operational failures.
• Contamination Risk: Poorly maintained extraction systems may become sources of contamination.
• Environmental, Health & Safety (EHS) Risk: Uncontrolled dust increases operator exposure and fire/explosion hazards, especially with combustible materials.

Key GMP Expectations

Regulatory authorities expect that dust extraction systems are appropriately designed, qualified, and maintained, particularly in environments with a high contamination or occupational exposure risk. Typical GMP expectations for this equipment type include:

• System is designed and commissioned according to a written, risk-based user requirement specification (URS).
• Extraction performance is qualified under process-representative operating conditions.
• Critical filter elements (e.g., HEPA) are challenged to demonstrate integrity and monitored for ongoing effectiveness.
• Control systems, including alarms and interlocks, are tested for correct operation and response to fault conditions.
• Records are maintained for operational status, maintenance, calibration, and filter changes.
• Cleaning, maintenance, and filter replacement are managed under controlled change or preventive programs.
• Data associated with automated monitoring are managed and reviewed for data integrity.

User Requirement Specification (URS) for Dust Extraction Systems

A well-crafted URS is the foundation of compliant selection, design, and validation for dust extraction systems. The URS should reflect the process needs, GMP expectations, and risk controls identified through prior risk assessments. Key sections typically include:

• General Description – Overview of application, products handled, and main process steps.
• Performance Requirements – Dust removal efficiencies, airflow/pressure specifications at each point, and filter grades (e.g., HEPA class).
• Control & Monitoring – Required alarms, data logging, user access control, and interface expectations.
• EHS Requirements – Operator protection, dust containment performance, filter change-out automation, safe disposal.
• Compliance – Standards that must be met (e.g., CE, ATEX, GAMP5), relevant GMP clauses, data integrity assurance.
• Maintenance & Validation – Expected intervals and methods for cleaning, filter integrity checks, and documentation needs.

Example URS Excerpt for a Tablet Compression Area Dust Extraction System:

• Minimum average airflow at each extraction point: 1200 m³/hr
• HEPA filters (H14 class) installed downstream of primary dust collector; filters must achieve >99.995% removal of >0.3μm particles
• Real-time differential pressure monitoring across each filter stage; alarms must trigger if pressure exceeds +60%/-30% of setpoint
• Data integrity features: 21 CFR Part 11-compliant audit trail for all alarm and maintenance events
• System must permit filter change-out without process room exposure (sealed bag-in/bag-out mechanism)
• Extraction must auto-stop with interlocked alarm in event of critical failure (power, blockage)

Risk Assessment Approach Shaping Qualification Strategy

The rationale for qualification planning relies on formal risk assessment, commonly employing Failure Modes and Effects Analysis (FMEA) style logic. This enables prioritization of controls, defines the extent of testing, and sets the verification regimen for ongoing performance. Key considerations in risk assessment include:

• Identifying likely failure modes (e.g., filter breach, blocked duct, alarm failure, inadequate airflow).
• Assessing the probability and detectability of each failure mode (e.g., filter clogging is likely but easily detected by pressure monitoring).
• Evaluating severity based on product quality, cross-contamination, and operator safety consequences.
• Defining specific qualification tests (e.g., airflow velocity mapping, HEPA integrity test, alarm simulation) for high-severity or high-likelihood risks.
• Linking periodic verification and preventive maintenance to failure modes with moderate likelihood or high detectability.
• Identifying which data elements must be recorded to support product release decisions or compliance checks (e.g., alarm status, filter change log).

For example, failure of the HEPA filter stage in a tablet compression area is a high-severity, low-likelihood event—controlled by direct integrity testing, differential pressure monitoring, and alarm verification as part of the qualification protocol.

The next sections continue the qualification storyline with practical tests, evidence expectations, and lifecycle controls appropriate for this equipment.

Supplier Controls and Vendor Qualification for Dust Extraction Systems

An essential first step in dust extraction system validation is establishing robust supplier controls. Dust extraction units for oral solid dosage (OSD) manufacturing are classified as GMP-critical equipment, responsible for containment of airborne particulates and safeguarding product, operator, and environment. Selecting a qualified vendor, therefore, significantly impacts long-term compliance and equipment performance.

Vendor Qualification Process

The process begins with a formal vendor qualification, incorporating an evaluation of the supplier’s track record in the pharmaceutical sector, especially regarding supplying, installing, and validating dust extraction systems. Due diligence includes review of the supplier’s quality management systems (ISO 9001 is typically expected), after-sales support, calibration service capabilities, and history of regulatory compliance.

• Site audits: Where possible, perform on-site audits to assess manufacturing, FAT facilities, and documentation control.
• Past performance: Check reference installations, ideally for equivalent OSD applications.
• Quality documentation: Evaluate the contents and format of their document package (e.g., validation protocols, test certificates).

Supplier Document Package and Material Certificates

The document package accompanying the dust extraction system should be detailed and structured. As part of the acceptance process, the following documents must be included, reviewed, and referenced in validation plans:

• Certificates of compliance: Materials contact certificates (EN 10204, 3.1B or equivalent) for all product-contact parts, referenced to as-built serial numbers.
• Welding and surface finish records: Especially for systems with suck-back/recirculation involved in sensitive manufacturing processes.
• Electrical conformity: CE/UKCA/UL certificates, hazardous area compliance if installed in classified zones (ATEX/IECEx etc.).
• Drawings and O&M manuals: P&IDs, wiring diagrams, system layouts, and full operations and maintenance manuals.
• Control software documentation: If PLC/SCADA or local HMI is present, provide software versions, configuration backups, and user manuals. Any software-related GAMP 5 documentation (e.g., FAT software test results, configuration specifications) must be included and reviewed.

Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) Approach

The FAT is designed to ensure that the dust extraction system, as fabricated, meets both the manufacturer’s specifications and the User Requirement Specification (URS). Typically conducted at the supplier’s site with QA and engineering representatives, the FAT should address all functional, safety, and performance aspects without the complexities of site-specific utilities.

• FAT scope: Visual inspection, verification of construction materials, demonstration of airflow (using calibrated test equipment), filter integrity, interlocks, alarms, and start/stop logic.
• Witnesses: At least one user site QA/engineering lead, with the vendor’s test engineers; sometimes include third-party QA if corporate policy, or when multiple sites are involved.
• Deviation management: Clear documentation of all deviations to specification, including root cause, risk assessment, and agreed corrective actions, with traceable closure.
• SAT: Performed post-installation to confirm operational compliance under site-specific utility conditions, with particular focus on integration with environmental control and facility interlocks.

Design Qualification (DQ) of Dust Extraction Systems

Design Qualification drives assurance that the supplier’s proposed system will meet essential GMP and performance criteria. The DQ is a systematic review, typically jointly conducted by the end user, project engineering, and QA, focusing on:

• Reviewing key drawings: General arrangement, P&ID, electrical/pneumatic diagrams, and filter/hopper layout.
• Confirming materials of construction: Stainless steel grades (e.g., 304/316L for cGMP contact), FDA/USP Class VI elastomers/gaskets for product-touching zones, ATEX-rated parts for explosion protection if needed.
• Assessing hygienic/cleanable design: Minimize dust retention zones, provide smooth internal finishes, ensure adequate CIP/SIP access if specified, and adequate cleaning/maintenance access.
• Utility interfaces: Power, compressed air (to actuate dampers or vibrators), differential pressure tapping for filter monitoring, and integration to BMS/HVAC if fan speed or airflows are monitored centrally.
• Filter technology: Type (HEPA, bag filter, cartridge), performance rating, change-out procedures and monitoring provisions (ΔP sensors).

Installation Qualification (IQ) Activities – Planning and Execution

IQ formally verifies that the dust extraction system is installed according to design and GMP requirements, with all components properly integrated and ready for operational qualification.

• Installation checks: Inspect the physical location, anchoring, orientation, and adequacy of clearance for maintenance/safety.
• Utility supply verification: Validate utility connections (power supply – correct phase/voltage, compressed air outlet pressure/quality, grounding); test circuit integrity, power quality (especially where systems include VFDs or servo-driven fans).
• Instrumentation calibration: Verify all critical pressure, airflow, and temperature sensors (as applicable) are present, with calibration certificates traceable to standards. Document calibration status and next due date.
• Labeling and tagging: Confirm equipment ID tags, safety labels, flow direction markings, ESD/ATEX signage, and instrument serial numbers match the project documentation.
• As-built dossier completion: Capture final P&ID/as-built layouts reflecting any permitted deviations; file all certificates and punch list items for closure.
• Safety checks: Validate all emergency stops, isolators, alarm functions, and ensure machine guards/interlocks are in place.

Environmental and Utility Dependencies

Dust extraction systems’ validation is tightly interlinked with broader facility controls. Critical dependencies include:

• HVAC class: The connected process or production room should match the specified cleanliness class (e.g., Grade D or ISO 8) to assure filtration and extraction logic supports room differential pressures and air change requirements.
• Compressed air: Where system actuators rely on compressed air, supply must meet ISO 8573-1:2010 air quality level (particulate, moisture, oil) matching product and equipment risk. Dew point and oil carryover must be regularly checked.
• RO/PUW/Water steam: While not typically used for standard dust collection, any integrated CIP/SIP (if present) must be linked to the validated quality water/steam supply, per system specifications.
• Power quality and grounding: The system’s fan motors and controls must be protected from voltage fluctuations/harmonics; grounding integrity should be periodically verified, especially in high-dust explosive environments (see EN 1127, NFPA 654, etc.).

Typical acceptance criteria specify minimum/maximum airflow rates, maximum allowable particulate release, differential pressure startup and block setpoints, and confirmation that under worst-case HVAC/facility operation, dust migration into GMP spaces is within limits.

Traceability Table: URS to Test and Acceptance

Checklist: Supplier Documentation, DQ, and IQ Essentials

The next sections continue the qualification storyline with practical tests, evidence expectations, and lifecycle controls appropriate for this equipment.

Operational Qualification of Dust Extraction Systems for Oral Solid Dosage Forms

The operational qualification (OQ) phase is a critical stage in dust extraction system validation for oral solid dosage manufacturing in GMP environments. OQ focuses on verifying that the installed system performs consistently within specified operating ranges and under actual usage conditions. This ensures that the system reliably controls dust emissions, safeguarding both product quality and operator safety.

OQ Scope and Approach

OQ is conducted using test protocols designed based on user requirements (URS), functional specifications (FS), and system design documentation. The primary goals of OQ for dust extraction include:

• Verifying operational functionality of all system components and controls
• Establishing and documenting operating ranges, setpoints, and system responses
• Checking all measured and controlled parameters (e.g., airflow, negative pressure, filter differential pressure) under simulated load
• Validating safety and compliance features (e.g., alarms, interlocks, emergency stops)
• Testing system responses to challenge scenarios

Functional Tests and Operating Ranges

Execution of OQ involves a stepwise demonstration that the dust extraction system operates as intended in all clinical and routine production scenarios. Key tests and their objectives include:

• System Startup/Shutdown: Confirm that the system powers up and powers down smoothly following SOPs. All components (motors, blowers, dampers, filters) must show correct sequence operation.
• Airflow and Differential Pressure Measurements: Measure and verify that airflow (e.g., 2000–2500 m³/hr as a dummy acceptance range) and negative pressure (e.g., -1200 to -1800 Pa) meet specifications at key extraction points.
• Filter Integrity and Monitoring: Observe and log pressure drops across primary and secondary filters. Automatic filter monitoring alarms and status indications must be functional.
• Setpoint Verification: Test and confirm the proper functioning of adjustable parameters; for example, high differential pressure alarm set at 2000 Pa (dummy value) should trigger at or very close to this value.
• System Response to Challenge Scenarios: Simulate events such as partial duct blockage, filter saturation, or air velocity drop. Confirm the correct activation of alarms and system responses.
• Alarms and Interlocks: Activate low/high airflow, excessive dust collection, and over-temperature simulation to verify alarm visibility, sound, and logging. Equipment interlocks (e.g., preventing operation without dust extraction active) must be demonstrated.

Instrumentation Checks and Calibration Verification

Precise instrumentation is essential for process consistency in dust extraction. During OQ, each critical instrument is verified for both correct type and calibration status as per manufacturers’ certificates or in-house calibration program records. Required actions include:

• Verification of installation integrity and correct scale use on pressure gauges, airflow sensors, and differential switches
• Calibration status checks for each device (sticker, certificate, or CMMS record—no expired calibrations allowed)
• In-situ verification of readings against calibrated, traceable standards—e.g., confirming differential pressure gauge shows within ±3% of standard under test
• Recording as-found/as-left values and deviations, with traceable documentation

All findings and calibration certificates are appended to the OQ report. If any instrument is found out of tolerance, root cause and re-testing steps are mandated.

Computerized System OQ and Data Integrity Controls

Many modern dust extraction systems for oral solid dosage forms incorporate Programmable Logic Controllers (PLC) or higher-level Building Management System (BMS) integration. In such cases, computerized system OQ steps specifically address data integrity and compliance with 21 CFR Part 11 and EU Annex 11:

• User Access and Security: Verify unique logins, password policy enforcement (e.g., minimum 8 characters, automatic timeout), role-based access to critical functions (e.g., only supervisors can alter alarm setpoints).
• Audit Trail: Activate and review audit trail features to confirm all key actions (setpoint changes, alarm acknowledgments, system resets) are logged with date/time/user identification.
• System Time Synchronization: Confirm that system clocks are set correctly and events are recorded in actual time, checking synchronization to site time server.
• Data Backup and Restore: Simulate data loss scenarios (backup, then restore) and confirm that all configuration, operational, and audit trail data are intact post-recovery.
• Electronic Record/Signature Controls: Where electronic logs are used for production documentation, ensure that signature controls and review functionalities are active and functioning.

GMP Operational Controls

Integrating OQ outcomes into the facility’s daily operations is an essential GMP requirement. This encompasses:

• Line Clearance and Cleaning: Before every production run or equipment change, executed and documented line clearance to confirm dust extraction system is clean, assembled, and free from prior product residues.
• Status Labeling: Clear visible tags/stickers indicating equipment status: “Qualified,” “Ready for Use,” “In Maintenance,” or “Not for Use.” These labels help prevent inadvertent use of non-qualified systems.
• Logbook and Recordkeeping: Log entries for each use, including batch number, time, any deviations, and maintenance/inspection actions, either on paper or via validated electronic systems.
• Batch Record Integration: Ensure dust extraction run parameters and relevant alarms/resets are referenced or attached to the batch manufacturing records as evidence of GMP compliance during each product run.

Verification of Safety and Compliance Features

Environmental Health and Safety (EHS) controls are embedded into dust extraction systems to protect personnel, products, and the facility itself. The following features are examined during OQ:

• Guarding and Enclosure Checks: Confirm that all rotating equipment, high-voltage panels, and filter housings have proper safety covers; attempts to operate with open guards must result in stoppage.
• Emergency Stop Functionality: Activation of E-stop buttons at all designated locations should cut power/control to all moving components instantly and generate a record in the alarm log.
• Pressure Relief Devices: Verify the presence, accessibility, and proper setting of pressure relief valves or rupture panels. For example, burst pressure set at 2,500 Pa (dummy value) is confirmed by secondary instrumentation.
• Interlock Verification: Simulate failure of one safety system (e.g., open filter door) and confirm that process operation is impossible until the issue is rectified.
• Alarm and Notification Systems: Visual/audible alarms must be functional and provide clear information to operators.

All EHS and compliance checks are documented with “pass/fail” results, and any non-conformances trigger immediate investigation and remediation.

OQ and Data Integrity Checklist Example

Completion of thorough OQ for the dust extraction system, including robust checks of functional capability, calibration, computerized controls, and GMP/EHS requirements, is essential for qualified operation in oral solid dosage manufacturing.

The next sections continue the qualification storyline with practical tests, evidence expectations, and lifecycle controls appropriate for this equipment.

Performance Qualification (PQ) for a Dust Extraction System

In the validation lifecycle of a dust extraction system for Oral Solid Dosage (OSD) forms, Performance Qualification (PQ) is pivotal. PQ focuses on demonstrating that the dust extraction system consistently performs in accordance with pre-established criteria under simulated or actual manufacturing conditions. Both routine and worst-case scenarios must be considered to establish system robustness and ensure patient safety.

Routine and Worst-Case Strategies

Routine PQ involves operating the dust extraction system during typical production runs with regularly processed products, representing day-to-day conditions. In contrast, worst-case PQ challenges the system with the highest expected dust loads, most difficult-to-remove dust types, and maximum throughput or batch sizes. This might involve producing highly dusty products or operating at the upper edge of capacity and duration limits.

For OSD manufacturing, worst-case PQ may include:

• Using products known to generate the finest, most adhesive dust.
• Testing the system at its highest rated flow and negative pressure levels for maximum duration.
• Deliberate partial clogging of the filter elements to assess alarm and shutdown triggers.

PQ Sampling Plan, Repeatability, and Acceptance Criteria

Sampling should be statistically justified, typically covering the system’s inlets, outlets, ducts, and critical exhaust points. Repeatability is demonstrated by performing at least three consecutive PQ runs for each critical parameter. Reproducibility may be shown by conducting PQ runs across different operators or shifts if manual system interventions are involved.

Example dust extraction system PQ assessment table:

Cleaning and Cross-Contamination Controls

Even though dust extraction systems are generally not in direct product contact, their effective operation is vital to prevent cross-contamination. Residual dust can harbor active pharmaceutical ingredients (APIs) and excipients. PQ must demonstrate that system cleaning (vacuuming, filter changeout, wipe down of accessible ductwork) consistently reduces residues to below defined safe thresholds.

If a swab/rinse sampling approach is used within ductwork accessible parts, cleaning validation/verification should be scheduled post-PQ runs, especially after worst-case product use. Acceptance limits for residues should be set based on product toxicology, batch size, and operator safety.

Continued Process Verification and Ongoing Qualification

The validated state of the dust extraction system must be maintained through ongoing process verification. Typical approaches include:

• Routine monitoring of key parameters (airflow, pressure differentials) as part of batch release protocols.
• Periodic re-verification of cleaning effectiveness, especially after product changes or system modifications.
• Annual reviews of system performance data for trending and early detection of drift from validated parameters.
• Incorporating continued qualification tasks into preventive maintenance and calibration schedules.

SOPs, Training, and Maintenance/Calibration Requirements

The robustness of dust extraction system validation is heavily dependent on sound procedures and practices, including:

• SOPs: Comprehensive SOPs must cover operation, routine monitoring, cleaning procedures, filter replacement, system shutdown, and troubleshooting. Documented user instructions for performing and recording PQ activities are essential.
• Training: Operators, maintenance, and quality personnel must be trained and periodically requalified on SOPs related to dust extraction system control and qualification.
• Preventive Maintenance and Spares: Scheduled filter replacements, ductwork inspections, and fan calibration must be documented. A robust spares program ensures critical components (e.g., HEPA filters, motor drives) are readily available.
• Calibration: All monitoring instruments (manometers, differential pressure gauges, airflow meters) should be on a routine calibration program traceable to national/international standards.

Change Control, Deviations, and CAPA Linkage

Any modification to the dust extraction system (hardware, software/automation controls, duct routing, filter types) must go through formal change control. The risk assessment underlying change control should determine the need for requalification or PQ repeat, based on potential impact on system performance or cleaning ability.

Deviations encountered during PQ or routine use—such as alarm failures, airflow drops, or dust breakthrough—must be investigated. Corrective and Preventive Actions (CAPA) should address root causes, prevent recurrence, and may trigger partial or full requalification, depending on impact severity.

Validation Deliverables and Documentation

Comprehensive and traceable documentation is a compliance cornerstone. For dust extraction system validation, deliverables typically include:

• PQ Protocol: Describes test objectives, methodology, sampling locations, acceptance criteria, equipment to be used, and responsibilities.
• PQ Report: Summarizes execution, results (including data tables, graphs), deviations and their disposition, and overall conclusions.
• Traceability Matrix: Links executed test steps and results back to specific User Requirements Specifications (URS) and risk assessments.
• Validation Summary Report: Integrates findings from DQ, IQ, OQ, and PQ for complete end-to-end traceability.
• Supporting Records: Includes raw data, calibration certificates, maintenance logs, training records, and any CAPA or change control documentation relevant to the scope of PQ.

Frequently Asked Questions: Dust Extraction System Validation

How often should PQ be repeated for a dust extraction system?

PQ should be repeated following any significant change (hardware/software modifications, major repairs, new product introduction), as well as on a periodic (e.g., 2-3 years) cycle based on risk assessment and system criticality.

Is cleaning validation mandatory for dust extraction systems?

While not all parts are product-contact, cleaning validation is important for sections where cross-contamination risk exists—e.g., filters and accessible ducts that may become contamination sources if cleaning is inadequate.

What are typical acceptance criteria for dust extraction system PQ?

Acceptance criteria vary, but commonly include sufficient airflow at all intake hoods, filter pressure within range, and ambient dust levels below threshold. All system trips, alarms, and interlocks must function per design.

What records should be kept to support ongoing verification?

Operators should maintain logbooks for system checks, calibration certificates, maintenance and part replacement records, and periodic performance verification data (e.g., airflow, dust measurements).

How does change control impact PQ status?

Any change to the system must be evaluated for validation impact. Major changes may require complete or partial PQ repetition, while minor parameter tweaks might only require documentation and risk assessment.

Who should be trained on dust extraction system SOPs?

Operators, mechanics, and cleaning or QA personnel who interact with the system or its validation material must be trained and their records kept current.

What should be included in the PQ protocol for a dust extraction system?

The protocol must describe procedural steps, sampling plan, pass/fail criteria, data recording method, handling of deviations, and references to applicable SOPs.

What triggers a CAPA during PQ?

Any deviation from test procedures or failure to meet acceptance criteria should initiate a deviation investigation and, if systemic or recurring, a CAPA process for corrective action.

Conclusion

Robust dust extraction system validation is essential to ensuring GMP compliance and product quality in oral solid dosage manufacturing. A clear focus on PQ strategies, ongoing verification, disciplined documentation, and proactive change management provides assurance that airborne cross-contaminant risks are controlled and regulatory expectations are met. With well-defined protocols, trained personnel, and robust maintenance, a validated dust extraction system continuously supports both patient safety and operational excellence.