Pellet Capsule Filling Machine Performance Qualification (PQ)

PQ of Pellet Capsule Filling Machine: Scope, Criticality, and GMP Principles

Pellet capsule filling machines play a crucial role in the manufacturing of oral solid dosage forms. These machines are designed to fill hard gelatin or HPMC capsules with pharmaceutical pellets—typically multiparticulate formulations such as taste-masked particles, modified-release pellets, or combination therapies. Performance Qualification (PQ) of these machines is a pivotal step in ensuring consistent, compliant, and safe product output for clinical and commercial supply.

Role of the Pellet Capsule Filling Machine in Oral Solid Dosage Manufacturing

The pellet capsule filling machine is integrated downstream of pellet formulation and upstream of packaging. After granulation and drying, pellets are blended as required and delivered to the filling station. The equipment is responsible for:

• Accurately dosing defined quantities of pellets into individual capsules
• Maintaining capsule integrity (no splits or empty capsules)
• Minimizing product loss and cross-contamination
• Facilitating each batch’s traceability and segregation

Its intended use boundary encompasses GMP production environments where batch consistency, fill weight accuracy, and physical segregation between products/batches must be strictly controlled.

Validation/Qualification Scope for Pellet Capsule Filling Machine PQ

The scope of PQ for pellet capsule filling machines includes:

• Verification of performance parameters under routine and worst-case conditions (e.g., maximum/minimum fill weight, capsule size range)
• Assessment of fill weight accuracy and precision with target pellets
• Testing of mechanical operation (capsule opening/closing, pellet dosing, rejection mechanism)
• Cleanability and changeover capability between batches
• User interface and electronic data management (batch records, alarms)

Out of scope:

• Upstream pellet manufacturing and downstream packaging validation
• Qualification of facility utilities (e.g., HVAC, compressed air) except as directly interfaced with the filling machine
• Software validation beyond PLC/HMI functions directly connected to machine control and data storage
• Raw material (capsule shell or pellet) release testing

This tightly focused approach improves traceability and makes troubleshooting more manageable during production and future audits.

Criticality Assessment: Product & Patient Impact, Data Integrity, and Risk

Qualification of a pellet capsule filling machine directly supports patient safety and drug quality. The table below summarizes core critical requirements, their associated risks, and the control/test approach:

Assessment highlights:

• Patient risk: Any major deviation in pellet fill weight or improper capsule sealing could result in therapeutic failure or adverse reactions.
• Product contamination risk: Poor cleaning or ineffective changeover may transfer potent actives between batches, triggering cross-contamination recalls.
• Data integrity: The machine’s role in recording and verifying process data makes robust controls over HMI, audit trails, and printouts essential.
• EHS risk: Machines must prevent dust escape and pinch-point injuries through robust engineering controls and interlocks.

GMP Expectations for Pellet Capsule Filling Equipment

Regulatory bodies and internal quality teams expect the following for pellet capsule filling machine PQ in GMP facilities:

• Reliable and validated weight control mechanisms for each capsule (e.g., statistical sample checks, automated feedback if present)
• Robust prevention measures for cross-contamination and product mix-ups (e.g., validated cleaning, physical barrier design, recipe change controls)
• Electronic record systems to be ALCOA+ compliant (attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available)
• Mechanical and automated safeguards to avoid filling errors (e.g., capsule count mismatch alarms, reject bin confirmation)
• Cleaning and maintenance procedures must be defined, performed, and recorded with traceable accountability
• Changeover protocols with clear steps for line clearance
• Operator safety and ergonomic considerations to prevent exposure and injuries

These expectations are embedded in site quality systems, SOPs, and are articulated in the machine’s qualification protocols.

User Requirement Specification (URS) Approach for Pellet Capsule Filling Machines

The URS serves as the foundation for procurement, design, and qualification of equipment. For pellet capsule filling machines, the URS should address the following core sections:

• Intended Use: Capability to fill capsules (sizes 0–4) with multiparticulate pellets at target throughput
• Performance Requirements: Fill weight accuracy (+/- 2% RSD), fill rate (e.g., 50,000 capsules per hour), supported pellet size range
• Regulatory/GMP Compliance: Design for cleaning, material traceability, and 21 CFR Part 11-compliant data management
• Safety & Ergonomics: Operator enclosures, dust extraction, emergency stop, interlock requirements
• Integration & Utilities: Interface with MES/SCADA if relevant, compressed air, vacuum, electrical supply specs
• Documentation: Requirement for vendor qualification/validation support documents, user manuals, wiring diagrams

Example URS excerpt:

• Fills hard gelatin capsules size 0–4 with uniformity of fill weight ≤2% RSD
• Supports pellet type A (0.5–1.2 mm diameter), type B (1.2–1.8 mm diameter)
• Equipped with HMI for recipe management and electronic batch record
• All product contact parts to be 316L stainless steel and removable for cleaning
• Integrated dust extraction system with HEPA filtration
• GMP-compliant change part storage and labeling system

Risk Assessment Fundamentals for Qualification Planning

The qualification plan should reflect a risk-based approach, prioritizing systems and process parameters most critical for product and patient safety. FMEA (Failure Modes and Effects Analysis) principles can shape the depth of PQ studies:

• Example: Fill weight control
  Failure mode: Weighing mechanism drifts out of calibration.
  Effect: Sub- or super-potent capsules.
  Control (Test): Simulate extended run PQ to monitor accuracy and robustness of in-process controls.
• Example: Capsule integrity
  Failure mode: Sealing station misaligned.
  Effect: Capsules leak, releasing pellets.
  Test: Routine and stress condition runs, including off-spec capsule shell challenge.
• Example: Cleaning/changeover risk
  Failure mode: Poor design leads to trapped powder.
  Effect: Carry-over between batches.
  Control: Visual inspection, swab/rinse recovery, training verification.

These analyses should be linked directly to PQ protocol test points, ensuring that real-world risks are addressed and documented. Risk tools should be revisited upon any changes in equipment configuration or process parameters.

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

Supplier Controls for Pellet Capsule Filling Machine PQ

Robust supplier controls are fundamental to achieving a compliant and effective pellet capsule filling machine performance qualification (PQ). Selecting a supplier with proven experience in GMP-compliant equipment and reliable quality systems minimizes project risks and ensures a complete, cGMP-ready documentation package. Below are detailed considerations tailored to equipment destined for oral solid dosage production environments.

Vendor Qualification

The initial phase involves thorough vendor assessment. Pharmaceutical companies must verify the supplier’s QMS, regulatory compliance history (including US FDA and EU cGMP track record), and capacity for providing lifecycle support. Audit reports, client references, and evidence of continuous improvement programs represent critical qualification deliverables. Pre-approval may additionally require physical audits focusing on quality control, production, and documentation practices.

Supplier Documentation Package

A comprehensive document package from the equipment vendor is key for PQ readiness. The required files should include, but are not limited to:

• Machine technical data sheet, capacity, and model-specific description
• As-built engineering drawings (P&IDs, pneumatic/hydraulic, GA and detailed views)
• Material certificates for product-contact and non-contact components
• Weld maps and certificates (for hygienic applications)
• Change parts list & interchangeability matrix
• Instrumentation calibration certificates and traceability to national/international standards
• Software documentation: user requirements, functional/logic diagrams, IQ/OQ test scripts, source version control references, and audit trail functionality (if automated machine)
• Quality certificates, FAT/SAT protocols & reports, operations and maintenance manual
• Risk assessment and mitigation actions

Checklist — Essential Supplier Documentation & DQ/IQ Inputs

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

Prior to shipment, the pellet capsule filling machine should undergo a Factory Acceptance Test (FAT) at the manufacturer’s facility. FAT ensures all specification and safety requirements are met. Key FAT activities for this equipment typically include:

• Verification of mechanical and control system function (e.g., fill weights, dosing accuracy, reject mechanism, and safety interlocks)
• Evaluation of operator HMIs, alarms, recipe management (for semi/fully automated systems), and adherence to electrical and explosion safety codes
• Review of calibration status, instrumentation function, and batch reporting logic
• Check of hygiene and cleanability features including smoothness of product-contact surfaces and drainability

Witnessing: Pharmaceutical client representatives (engineering/validation) and QA personnel must witness critical FAT steps. All non-conformances must be recorded within the protocol, supported by a deviation management workflow assigning short-term resolution or open-action recommendations for pre-SAT closure.

Site Acceptance Test (SAT) is typically performed post-installation. SAT verifies as-installed performance, utility integration, and post-transport equipment integrity prior to commencing PQ/IQ. SAT serves as a final confirmation ensuring no transit or site integration damage, and that the filling machine’s as-built configuration aligns with the qualified state.

Design Qualification (DQ) for Pellet Capsule Filling Machine

The design qualification phase confirms, through documented evidence, that the selected equipment design meets user-defined process requirements and regulatory expectations. DQ for pellet capsule filling equipment must focus on:

• Comprehensive review of design documents and revision-controlled drawings (mechanical, process, and controls)
• Verification of materials of construction for product contact components (e.g., 316L stainless steel, FDA-grade polymers)
• Examination of gasket, seal, and closure types: integrity, chemical compatibility, and cleanability certification
• Assessment of hygienic design features: weld finishes, dead-leg minimization, access for cleaning/inspection, residue removal
• Review of risk assessments against cross-contamination, mechanical and software failures, HEPA and electrical safety, and explosion risk (as relevant to the product handled)
• Conformance to URS: capsule size range, filling accuracy, reject logic, batch sizes, sampling capabilities, and cleaning methodology
• Functional description of software—alarms, user access restrictions and audit trail functionality

The DQ document captures gaps and recommendations, which feed into the accepted as-built and maintenance documentation, forming the basis for subsequent IQ and OQ activities.

Installation Qualification (IQ) Planning and Execution

Thorough installation qualification (IQ) is essential to confirm that the pellet capsule filling machine is installed according to design intent and supplier recommendations. IQ planning for this equipment consists of:

• Verification of equipment location within designated GMP area, referencing layout drawings
• Checks on as-built and as-installed machine configuration, confirming delivery of all major modules, accessories, and change parts
• Utility verification: Incoming electrical (voltage, phase, frequency), compressed air (pressure, dew point, oil content), steam (if applicable), and purified water/RO for cleaning when required
• Label check for all piping, instrumentation, and electrical lines per P&ID
• Calibration status and certificates for integrated instruments (sensors, weigh cells, HART devices, etc.)
• Installation of safety devices (emergency stops, guards, interlocks) and function tests
• Environmental conditions: cleanroom/HVAC integrity in accordance with installation location class (typically ISO 8/Class 100,000 or better)
• Documentation assembly: verified as-built dossier, calibration certificates, up-to-date drawings, service agreements, and a log of open punch-list items

Typical IQ activities are documented through checklists, with punch-lists and corrective actions tracked until closure; deviations are escalated in accordance with site SOPs.

Environmental and Utility Dependencies

The performance and compliance of a pellet capsule filling machine depend on the supporting utilities and environmental conditions. Example acceptance criteria include:

• HVAC/Cleanroom Environment: Location confirmed within designated grade (e.g., ISO 8, Grade D), monitored temperature (±2°C), RH (±5%)
• Compressed Air Supply: Oil-free, filtered to 0.01 micron, dew point as per machine vendor specification (< -20°CDP), pressure stable within range (e.g., 6-8 bar)
• RO/PUW or WFI: Source is GMP-qualified, routine monitoring meets microbial and TOC acceptance limits
• Electrical Power Quality: ±5% voltage fluctuation, dedicated neutral, grounding as per electrical code, uninterrupted supply during operation
• Steam Supply (if for cleaning or capsule sealing): Quality checked (no visible particulates or condensate), pressure monitored with independence from process utilities

Traceability Matrix Example: URS to PQ Test Mapping

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

Operational Qualification (OQ) for Pellet Capsule Filling Machine

Operational Qualification (OQ) is a critical phase in the validation lifecycle of pellet capsule filling machines used in Oral Solid Dosage (OSD) manufacturing. The objective of this stage is to comprehensively verify and document that the machine and its supporting utilities function as intended across all critical operating ranges. For pellet capsule filling machine PQ, this means every function impacting dosage accuracy, quality, and compliance must be individually challenged and proven robust under simulated production conditions. The OQ activity provides documented evidence that the equipment is prepared for its intended GMP use, bridging Installation Qualification (IQ) and the subsequent PQ phase.

Functional Tests and Operating Ranges

During OQ, each critical function of the pellet capsule filling machine is subjected to rigorous testing and observation. These tests typically include:

• Main Drive System: Verification of motor start/stop and speed settings. For example, confirming the main drive consistently achieves speeds from 10 to 50 capsules/min as per manufacturer recommendations.
• Capsule Hopper and Feeder: Testing smooth, jam-free capsule feeding at all machine speeds. This includes low-level sensor and agitation function where installed.
• Pellet Dosing System: Challenge tests for dosing accuracy across predefined weight/specification ranges (e.g., ±2% of 150 mg fill weight, sample acceptance criterion).
• Rejection System: Intentionally producing defective capsules (e.g., unfilled or overfilled) to check the performance of automatic rejection and collection mechanisms.
• Operator Interface Panels: Verification of all setpoints, displays, alarm indicators, and HMI screens for clarity and responsiveness.
• Capsule Closing Unit: Checking the alignment and force applied to close capsules securely without damaging shell integrity.
• Locking Mechanism: Confirmation that capsule locking operates within specification, producing leak-proof, tamper-evident seals.

All OQ testing must include both nominal and challenging conditions (minimum, nominal, and maximum settings) to assure robust machine performance under variable production requirements.

Alarm, Interlocks, and Setpoint Verification

• Safety and Process Alarms: All alarms—such as emergency stop, cover open, hopper empty, pneumatic/pressure drops, and overcurrent—are challenged. Acceptance criteria: Alarms must trigger within 1 second of event (sample value); system must move to safe state.
• Interlocks: All interlocks (main door, access covers, outfeed bin, etc.) are functionally tested to confirm the machine cannot operate unless all guards are securely in place.
• Setpoint Verification: OQ ensures all adjustable parameters (fill weight, speed, vacuum level, etc.) can be correctly set, controlled, and displayed accurately on the HMI.
• Challenge Testing: For key safety and process interlocks, challenge tests are performed (e.g., bypass simulation, forced open conditions) to confirm the system fails safe and records the event properly.

Instrumentation Checks and Calibration Verification

Instrumentation forms the backbone of reliable machine operation. During OQ, each critical sensor and instrument is checked for proper installation, calibration status, and function:

• Weighing Systems: Traceability to calibrated reference weights/certified balances is verified. Example acceptance: Reproducible readings within ±0.5% of set reference.
• Pressure/Vacuum Sensors: Function and calibration tags are checked. Readings are challenged with certified test gauges; acceptance: deviation not exceeding ±1% of full scale.
• Temperature Sensors: Where temperature is controlled (e.g., capsule pre-conditioning), probe response and error against traceable standard are documented.
• Level Sensors and Limit Switches: Tested via simulation; status feedback is confirmed at HMI.

All calibration verification should be carried out with reference to current calibration certificates, and results documented in the OQ report.

Data Integrity Controls for Computerized/Automated Systems

Modern pellet capsule filling machines are often equipped with programmable logic controller (PLC)-based, SCADA, or embedded computerized controls. Where present, OQ must include focused verification activities addressing data integrity as per FDA 21 CFR Part 11 / EU Annex 11 requirements:

• User Role Management: Verification that only authorized, uniquely identified users can access and operate or modify critical parameters. Typical roles: Operator, Supervisor, Engineer, QA.
• Audit Trail Testing: Ensuring the system logs all critical user actions, setpoint changes, alarms, and batch actions with date/time/user stamp. Logs must be tamper evident and not user-editable.
• System Time Synchronization: System clock must be correctly set and, where applicable, synchronized with plant master clock.
• Backup and Restore Functionality: Testing successful backup of configuration/data and complete restore to ensure data recovery capability—executed as a simulated disaster recovery scenario.
• Access Control Verification: Confirmation that password rules, lockouts, and session timeouts are enabled according to site IT policy.

GMP Controls: Line Clearance, Status Labeling, Logbooks, and Batch Record Integration

• Line Clearance: Documentation and visual inspection to confirm all previous products, materials, documents, and residues are fully removed prior to OQ and subsequent production use.
• Status Labeling: Applying clear “Under Qualification,” “Qualified,” or “Out of Service” status tags throughout OQ activities. Only equipment with correct, current status labels must be in use.
• Logbooks: Review and update of equipment logbooks during OQ to record qualification activities, issues, and maintenance actions. Entries must be legible, dated, and signed per GMP requirements.
• Batch Record Integration: Confirmation that OQ-validated control parameters (e.g., fill weight, capsule size, rejection limits) can be consistently and clearly transferred to official batch production documentation, facilitating GMP traceability and compliance.

Safety and Compliance Feature Verification (EHS & Regulatory)

• Emergency Stops: All emergency stop buttons on the filling machine and interface panels are challenged for function—machine must halt immediately, power is disconnected to hazardous components (e.g., main drive, servo).
• Mechanical Guarding: Integrity and locking of all operator guards and access panels are checked. Guard removal or improper closure must trigger a machine stop event.
• Pressure Relief/Blow-off Valves: If applicable, these are visually inspected and, where safe, tested for proper function, relieving excessive pressure to prevent operator injury or equipment damage.
• Noise/Ergonomic Factors: Noise levels may be measured (example acceptance: <80 dBA at operator station), and workstation design checked for compliance with EHS policies.
• Electrical Safety: Verification of functional earth (grounding), protection class labeling, and presence of required signs and warning labels on panels and controls.

OQ Execution Checklist – Pellet Capsule Filling Machine

This checklist can be customized to site procedures and supplemented with additional activities or acceptance criteria as specified by local regulatory or corporate validation policies. All OQ execution and data integrity verification for the pellet capsule filling machine should be meticulously documented, reviewed, and approved prior to progressing to the PQ phase.

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

Performance Qualification (PQ) Strategy for Pellet Capsule Filling Machines

The Performance Qualification (PQ) phase is the final critical step in the equipment validation lifecycle, confirming that the pellet capsule filling machine operates consistently and reliably under actual production conditions. PQ validates the system with real production materials, representative operators, and defined process parameters, ensuring dosage integrity, machine yield, and regulatory compliance for oral solid dosage forms.

PQ Approach: Routine and Worst-Case Scenarios

PQ for a pellet capsule filling machine typically includes both routine production runs and deliberate worst-case scenarios. The routine PQ verifies normal operating conditions using standard batch sizes, target speed, and capsules representative of the product family. The worst-case PQ addresses the upper and lower limits of filling range, smallest and largest capsule sizes, most challenging pellet properties (e.g., sticky or highly friable pellets), and extended run durations to evaluate prolonged machine performance, potential wear, and risk of cross-contamination.

Critical process parameters monitored include fill weight accuracy, uniformity of pellet distribution, capsule closure integrity, and reject rates. Environmental influences such as humidity and temperature, which could affect pellet flow, are also monitored when relevant.

PQ Sampling Plan, Repeatability, and Reproducibility

A well-defined sampling plan is essential for effective PQ. Replicate batches (usually at least three consecutive successful runs) help assess repeatability and demonstrate the machine’s ability to consistently meet quality specifications. Sampling points are strategically chosen across a batch—start, middle, end, and during changeovers or speed shifts—to assess reproducibility.

Below is an example table outlining typical PQ tests for a pellet capsule filling machine, suggested sampling schemes, and acceptance criteria:

Cleaning and Cross-Contamination Control Integration

As a product-contact machine, the pellet capsule filling equipment must be shown, during PQ, to allow effective cleaning and minimize cross-contamination risk. PQ batches should be strategically scheduled to support cleaning validation or verification studies—particularly when switching between different pellet formulations or capsule sizes. Swab and rinse samples may be collected after cleaning. The PQ protocol should define sampling locations (e.g., dosing chambers, pellet feed systems, capsule hoppers) and acceptable residue limits, supporting the cleaning validation’s acceptance criteria.

Documented evidence of effective cleaning after the PQ runs demonstrates that, even following a worst-case scenario (e.g., the highest product load, stickiest product), the equipment can be returned to a clean state and is suitable for the next production cycle, as expected under cGMP.

Continued Process Verification (CPV) and Ongoing Qualification

After initial PQ, a Continued Process Verification (CPV) program must be established. This approach involves periodic review of critical process data—fill weights, yield, rejection rates, cleaning outcomes—to verify ongoing performance and detect trends suggesting equipment wear, drift, or systematic issues. CPV may leverage statistical process control charts, trending of deviation/CAPA rates, and ongoing cleaning verification. Triggers for requalification include process changes, major repairs, or deviations indicating the potential for performance shift.

SOPs, Operator Training, Preventive Maintenance, and Calibration

A robust operating framework is essential to maintain PQ status:

• Standard Operating Procedures (SOPs): Clear, equipment-specific SOPs should cover setup, routine operation, cleaning, and troubleshooting of the pellet capsule filling machine. These must align with validated practices and be periodically reviewed.
• Operator Training: PQ only holds meaning if personnel replicate validated practices. Training records must demonstrate that all users are qualified per the SOP before using the system for commercial production.
• Preventive Maintenance: Scheduled maintenance routines (lubrication, part replacement, sensor calibration) prevent unplanned downtime and sustain process capability. Maintenance must be performed by trained staff and documented.
• Calibration Program: Key measurement devices (weight sensors, dosing monitors) must be regularly calibrated. Calibration status must be current before any PQ or production run.
• Spares Inventory: Adequate critical spare parts should be available to minimize downtime and avoid unqualified repairs.

Change Control, Deviations, and CAPA Linkages

Any changes to the pellet capsule filling machine (hardware, control software, settings, or process parameters) must be addressed through a formal change control system. The necessity for requalification is determined via risk assessment, focusing on potential impact to performance or product quality. Deviations observed during PQ or ongoing use must be logged, investigated, and closed out with appropriate corrective and preventive actions (CAPA). Examples include unexpected out-of-spec fill weights, persistent machine jams, or cleaning failures. These are integral to demonstrating a state of control and may trigger partial or full requalification depending on severity and root cause.

Validation Deliverables: Protocols, Reports, and Traceability

The documentation package for PQ should be comprehensive and structured:

• PQ Protocol: Clearly details objectives, scope, responsibilities, test descriptions, sampling plans, data collection forms, and pre-defined acceptance criteria. Includes stepwise instructions for both routine and worst-case scenarios, sampling locations, cleaning validation integration, and contingency plans for failure handling.
• PQ Report: Summarizes results for all tests against their acceptance criteria, includes raw and summary data, deviation investigations, and justifications for any departures from the protocol. Demonstrates traceability of each protocol requirement to raw data and test results.
• Summary Report: May encompass PQ as part of a master validation summary, concisely restating major findings, status of deficiencies/CAPA, and final conclusions as to system suitability for production.
• Traceability Matrix: Links each protocol test to the associated regulatory/user requirements, raw data, and resulting CAPA or follow-ups as necessary.

All validation deliverables must be reviewed and approved in accordance with company quality system procedures, and made readily retrievable for regulatory inspection.

Frequently Asked Questions (FAQ) – Pellet Capsule Filling Machine PQ

What is the primary goal of PQ for a pellet capsule filling machine?

To verify, under actual production conditions, that the capsule filling machine consistently produces capsules within specified quality parameters, including fill weight, content uniformity, and proper capsule closure.

How many PQ batches are required for this equipment?

It is typical to execute at least three consecutive, successful batches during PQ, covering both normal and worst-case operating scenarios. Local regulatory guidance and company SOPs may require more or less, depending on risk assessment.

What makes a scenario “worst-case” in pellet capsule filling machine PQ?

Worst-case conditions usually involve running the largest and smallest capsule sizes, the most difficult-to-handle pellets (e.g., densest, stickiest, or most friable), and operating at the extremes of speed and fill weight. These stress the system more than standard operating conditions.

What types of failures during PQ require immediate requalification?

Failures relating to critical quality attributes—such as consistent out-of-spec fill weights, systematic sealing issues, or cleaning failures that risk cross-contamination—require root cause investigation. Major failures may halt PQ and necessitate equipment requalification after CAPA implementation.

How does PQ interface with cleaning validation?

PQ assesses whether the filling machine can be effectively cleaned after both normal and worst-case production runs. Swab and rinse samples are often taken post-cleaning in PQ to support or confirm cleaning validation, proving the absence of residues or cross-contaminants.

Can operators perform routine production after successful PQ?

Only operators whose training is documented and who follow validated SOPs should perform production after PQ. Demonstrated adherence to trained practices is a regulatory expectation.

Are there circumstances where only partial requalification of the equipment is necessary?

Yes. If a change is limited (e.g., to a component unrelated to dosing accuracy), then targeted PQ tests may be repeated to confirm unaffected functions instead of a full requalification.

Conclusion

Performance Qualification of pellet capsule filling machines is essential to ensure reliable, compliant, and reproducible production of oral solid dosage forms. By incorporating rigorous testing strategies, robust documentation practices, integration with cleaning validation, and a strong emphasis on change management and training, PQ establishes ongoing assurance of equipment suitability. This comprehensive approach underpins both regulatory expectations and internal quality goals, securing product quality and patient safety throughout the equipment’s lifecycle.