Double Rotary Tablet Press Validation Overview

Introduction to Double Rotary Tablet Press Validation

The double rotary tablet press is a pivotal equipment in the manufacture of oral solid dosage (OSD) forms, notably tablets. As an automated, high-output machine, it transforms granulated mass into compressed tablets with precise shape, weight, and hardness. Given its critical function—directly forming the dosage unit for patient administration—comprehensive validation of this equipment is a fundamental expectation in current Good Manufacturing Practice (cGMP) environments. This segment provides a focused exploration of double rotary tablet press validation: its place in OSD manufacturing, validation boundaries, risk considerations, core GMP requirements, user requirements specification (URS) preparation, and how risk assessment underpins its qualification plan.

Understanding the Double Rotary Tablet Press

The double rotary tablet press, sometimes referred to as a “bilayer rotary press” when used for multicomponent tablets, consists of a turret housing both upper and lower punches and dies. As granules are fed via hoppers, rotary motion drives the material through a series of die stations, compressing the tablets in a rapid, continuous cycle. Output can range from tens of thousands to hundreds of thousands of tablets per hour, depending on turret size and configuration.

Location in Manufacturing: This equipment is typically positioned downstream of the blending and granulation steps, and before primary packaging. The press forms the final tablet and is thus a direct impact machine in the OSD process stream.

Intended Use Boundaries: The primary use is compressing pharmaceutical powders or granules into solid tablets within validated process parameters. It is not intended for non-tablet OSD forms, potent/highly active products without containment, or unapproved material classes. Any activity outside the validated range (e.g., different tooling, unqualified speed ranges, or off-spec materials) falls out of scope for typical production applications. Non-pharmaceutical or R&D-grade utilization (such as excipient-only compaction studies) should be explicitly managed by separate procedures.

Validation and Qualification Scope

Scope Includes:

• Installation Qualification (IQ): Ensuring correct installation, electrical connections, utilities, and environmental suitability.
• Operational Qualification (OQ): Verifying functional operation across defined ranges (e.g., speed, compression force, weight variation, safety interlocks).
• Performance Qualification (PQ): Demonstrating consistent tablet production under routine conditions with process-specific materials (matrixed if needed across product families).
• System controls and automation verification (Human-Machine Interface, programmable logic controller logic, safety features).
• Data acquisition, integrity, and batch record outputs.
• Cleaning validation interfaces (when applicable, e.g., direct product-contact parts).

Out of Scope:

• Building infrastructure qualification (HVAC, compressed air beyond point-of-use connections).
• Non-cGMP use (e.g., non-pharmaceutical production, research-scale batches unrelated to commercial supply).
• Tooling sets not specified/qualified in the User Requirements Specification.
• Material handling systems upstream or downstream (except direct interfacing points such as the feed frame).
• Operator training outside equipment operation specifics.

Criticality Assessment: Risk Dimensions

The double rotary tablet press is classed as “direct impact” equipment. Risk assessment is built around critical parameters where failures may translate to product quality or patient safety impact:

• Product Quality: Out-of-spec tablets (weight, hardness, content uniformity) due to mechanical malfunction or control failure.
• Patient Risk: Sub- or supra-potent tablets go directly to patients; undetected, such occurrences present clinical risk.
• Data Integrity: Electronic batch records, programmable settings, and audit trails must be robust; falsification or loss risks regulatory non-compliance.
• Cross-Contamination: Residual product from previous batches; risk mitigated by validated cleaning and design for easy disassembly.
• EHS (Environmental, Health & Safety): Powder containment, operator exposure to dusts or potent APIs, and moving mechanical hazards require strict controls.

GMP Expectations for Double Rotary Tablet Presses

Pharmaceutical regulations and guidelines expect that production-critical equipment like double rotary tablet presses be:

• Specified, designed, and configured to ensure product quality and patient safety throughout their lifecycle
• Maintained and calibrated as per a validated schedule
• Operated within pre-defined, qualified ranges
• Equipped with robust safety and interlock systems (for EHS and product security)
• Fitted, where applicable, with controls for in-process monitoring (e.g., tablet weight, hardness checks)
• Supported with traceable, secure, and archived batch and event data
• Designed for cleanability and prevention of cross-contamination between campaigns

User Requirements Specification (URS) – Approach and Examples

A robust URS for double rotary tablet press validation is foundational. It translates process intent and GMP risk into actionable equipment design and purchasing controls. A good URS addresses:

• Process Capability Requirements: Batch size, tablet shape, maximum compression force, adjustable production speed.
• Quality and GMP Needs: Material contact surface, cleaning design, data integrity features (audit trail, user access).
• Safety Controls: Guards, emergency stops, dust containment features.
• Automation and Control: PLC/HMI capabilities, recipe management, weight feedback controls.
• Integration Points: Feeder system, deduster, metal detector compatibility.
• Documentation: Manuals, certificates, part traceability.

Example URS Excerpt for a Double Rotary Tablet Press:

• Capacity: Minimum 110,000 tablets/hour (single-layer; round tablets 10 mm diameter).
• Compression force: Adjustable, 5–100 kN per station.
• Interface: 10-inch color touchscreen HMI with electronic signature and 21 CFR Part 11-compliant audit trail.
• Product contact parts: 316L stainless steel, USP Class VI certified.
• Tooling: B-type and D-type compatible turrets.
• In-process weight monitoring: ±2% tolerance, reject mechanism for out-of-spec tablets.
• Integrated dust extraction port with HEPA filtration.
• Safety: Light guard shutdown, emergency-off push-button on both sides.
• Comprehensive documentation: FAT/SAT protocols, installation drawings, part lists.

Risk Assessment Foundations for Qualification Planning

Qualification of a double rotary tablet press must be risk-based and traceable to critical process parameters. The Failure Modes and Effects Analysis (FMEA) model is typically adapted:

• Identify how each equipment feature/parameter can affect product quality, process integrity, or EHS.
• Rate severity, likelihood, and detectability of each potential failure (e.g., punch misalignment, sensor malfunction, data loss).
• Define controls: design features, alarms, routine checks, and qualification tests that mitigate each risk.
• Map these to qualification activities (e.g., OQ test for compression force feedback, data integrity challenge).

Illustrative Critical Requirement-Risk-Control Table:

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

Supplier Controls for Double Rotary Tablet Press Validation

Robust supplier management forms the cornerstone of double rotary tablet press validation in GMP environments. Due to the complexity and critical nature of these machines in the oral solid dosage manufacturing process, thorough vendor qualification, comprehensive documentation review, and strict control of supplied components and subsystems are essential to ensure regulatory compliance and product quality.

Vendor Qualification

The equipment manufacturer must undergo a formal qualification process prior to the order. Evaluating competency includes a review of:

• ISO 9001/GMP certifications and audit history
• Experience and references with double rotary tablet presses for pharmaceutical applications
• Quality management practices and supply chain controls
• After-sales service and technical support capabilities

Approved vendors should be listed and reviewed periodically as part of the pharmaceutical company’s supplier quality management system.

Document Package Requirements

Upon procurement, the supplier must furnish a document package tailored to the regulatory and operational complexity of a double rotary tablet press. Typical requirements include:

• Design documents: General assembly and sub-assembly drawings, process and instrumentation diagrams (P&IDs), control logic diagrams, electrical wiring schematics.
• Material certificates: 3.1/3.2 certificates per EN 10204 for all product contact and critical components, verifying material grade, identity, and traceability.
• Welding documents (if applicable): Weld maps, WPS/PQRs, and welder qualifications for product contact welds.
• Software documentation: If the press is equipped with programmable logic controllers (PLC), SCADA, or data acquisition systems, the package must include software versioning, source code summaries, architecture and user manuals, and an electronic record/e-signature (21 CFR Part 11) compliance statement, if needed.
• Calibration certificates: Factory calibration of instrumentation (e.g. load cells, pressure and temperature sensors, weight checkers, etc.), traceable to national/international standards.
• Operating and maintenance manuals: Detailing routine and preventive maintenance procedures, change part replacement, and recommended lubricants.
• Test records: Factory Acceptance Test (FAT) protocols and completed results, with any observed deviations and their rectification summary.

All documents should be delivered in both hard and soft (searchable PDF, native CAD where applicable) formats, controlled via document revision systems, and included in the as-built dossier.

Factory and Site Acceptance Testing (FAT/SAT)

FAT is generally performed at the supplier’s facility prior to shipment. Its purpose is to verify that the double rotary tablet press is built and operates in accordance with the purchase order, User Requirement Specification (URS), and relevant regulatory requirements. SAT is performed upon arrival at the pharmaceutical site to confirm installation integrity and transfer of FAT findings.

• What to Test:
  • Assembly verification versus approved drawings and part lists
  • Power-up and initial safety checks (e-stops, guards, interlocks)
  • PLC/HMI/SCADA control functionality including recipe management and alarm handling
  • Mechanical operation of tablet compression, feeder and discharge
  • Critical setpoint and sensor calibration verification
  • Material traceability (test runs with dummy product, if permitted)
  • Cleaning and sanitation system demonstration (CIP/SIP, if equipped)
  • Data integrity and audit trail functions
• Who Witnesses:
  • Pharmaceutical company subject matter experts (engineering, QA, production SME)
  • Supplier quality and technical leads
  • Third-party inspectors (where contracted)
• Deviation Recording:
  Deviations from protocol must be formally documented, investigated and resolved prior to shipment (FAT) or sign-off (SAT). All open deviations must include detailed impact assessment, correction, and, if not resolved before shipment, a planned action item with assigned responsibility.

Design Qualification (DQ) Focus for Double Rotary Tablet Press

DQ confirms the equipment design satisfies both process requirements and regulatory expectations. For a double rotary tablet press, the key DQ review elements include:

• Design review meetings: Ensuring team agreement on critical features such as turret design, feeder type, tooling compatibility (punches/dies), and integration with upstream/downstream equipment.
• Drawings: Verification of general arrangement, load distribution, cleaning zones, guard locations, and maintenance access according to latest revision controls.
• Materials of construction: All contact parts must be pharmaceutical grade stainless steel (e.g., AISI 316L), free from animal-derived lubricants, and surface finished to Ra ≤ 0.8 μm. Elastomers and plastics must be FDA compliant and traceable.
• Hygienic design: Review of design to ensure absence of dead legs, crevices, non-drainable surfaces, and ability to perform effective cleaning. Welds must be smooth, continuous, and documented. CIP/SIP suitability should be confirmed where required.
• Compliance with safety and environmental requirements: Verification of guarding, interlocks, ATEX zoning (if dust explosion risk), and noise containment.

Installation Qualification (IQ) Planning and Execution

IQ provides documented evidence that the double rotary tablet press is installed as per design and supplier recommendations, and is ready for further qualification and operation. IQ typically involves:

• Installation checks: Location aligns with facility plan, physical anchoring/leveling, integrity of packaging through transit, correct assembly of modules and critical fasteners torqued to specification.
• Utilities: Verification of provided connections against supplier requirements for:
  • Electrical power (voltage, phase, grounding, clean earth)
  • Compressed air (pressure, oil- and water-free, dew point requirements verified at point-of-use)
  • Clean steam (if CIP/SIP or humidity control required)
  • Reverse Osmosis (RO) or Purified Water (PUW) supply, if applicable
  • HVAC airflow and differential pressure in room versus adjacent areas
• Instrumentation: Inventory of all sensors, transmitters, and actuators; factory/setpoint calibration status; labels and tags matching P&ID.
• Calibration status: All critical measurement instruments checked for valid, signed calibration certificates with due dates; overdue calibrations must be resolved before use.
• Labeling and identification: Verification of all safety, warning, and instrument labels; asset tags affixed per plant standards and reconciled with asset management system.
• Safety checks: All e-stops, interlocks, guards and shielding in place and function-tested. Emergency shutdown circuitry and lockout/tagout points verified.
• As-built dossier: Compilation of supplier documentation, installation records, photographs, and updated “as-installed” drawings showing all modifications.

Environmental and Utility Dependencies

The performance and regulatory acceptability of a double rotary tablet press depends critically on its supporting environment and utility supply. Key considerations include:

• HVAC classification: Installation room should meet at least ISO 8/Class D for general tablet manufacturing. If the product is highly potent or moisture-sensitive, higher classification (ISO 7/Class C) with room differential pressure >10 Pa and temperature/humidity control may be mandated.
• Compressed air quality: Supply must be dry (<-40°C dew point), oil-free (<0.01 mg/m³), and bacterial free with suitable filtration and monitoring.
• Water & steam: Press with cleaning-in-place requires validated RO or PUW with conductivity <1.3 μS/cm at 25°C, and pure steam for SIP cycles.
• Power quality: Stable, grounded supply; voltage fluctuations <±5%, harmonics within EN/IEC limits; uninterruptible power supply (UPS) for sensitive PLC/SCADA segments.

Acceptance criteria for these conditions should be clearly listed within IQ protocols, with supporting data from Building Management System (BMS) and regular environmental monitoring records.

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

Operational Qualification (OQ) of Double Rotary Tablet Press: Protocols and Key Considerations

The Operational Qualification (OQ) stage in double rotary tablet press validation is a pivotal phase in confirming that the equipment consistently operates within the predefined limits and parameters under simulated production conditions. OQ systematically verifies that all functions, features, and controls perform as intended, ensuring robust compliance with GMP and regulatory requirements specific to oral solid dosage (OSD) manufacturing. The following sections outline the essential steps and practical details involved in the OQ process for double rotary tablet presses.

Functional Testing and Operating Ranges

At the onset of OQ, the tablet press is tested extensively under a range of operating settings defined by product-specific requirements and process risk assessments. The equipment is operated at designated minimum, normal, and maximum set points for critical process parameters, such as turret speed, main compression force, precompression force, feeder speed, and tablet ejection rate. The goal is to verify that:

• The press delivers consistent output across its specified range.
• Tablets produced at different settings meet predefined physical quality attributes (e.g., weight, thickness, hardness, and friability).
• All process alarms and interlocks function correctly to prevent unsafe or non-compliant operation.

Example acceptance criteria (for demonstration purposes):

• Tablet weight variation: ±2% of target weight across full speed range
• Compression force accuracy: Within ±5% of set value
• Turret speed: Operable from 10–80 rpm without vibration alarms

Challenge Tests and Safety Features

Challenge tests are conducted to intentionally trigger system responses, evaluating the responsiveness of critical alarms and safety features. These typically include:

• Emergency stop (E-Stop): Pressing the E-stop should immediately shut down all mechanical operations and isolate electrical circuits.
• Guard interlocks: Opening safety guards during operation must halt the press and activate visual or audible alarms.
• Overpressure relief: Initiate test sequences to confirm that pressure relief devices actuate at specified thresholds, protecting both operator and equipment.
• Feeder jam simulation: Manually induce feeder blockage and verify that sensors detect the fault and stop the press, with corresponding alarm generation.

During these tests, results must be documented real-time and compared against predefined acceptance criteria (e.g., “Guard interlock response time < 1 second”).

Instrumentation Checks and Calibration Verification

All critical sensors and instrumentation, including load cells (compression force), turret speed encoders, temperature probes, and thickness detection devices, must be verified against calibrated references. Calibration status, stickers, and certificates must be checked and recorded as part of the OQ process. Verification includes:

• Compression force sensor: Calibrated to NIST-traceable standard; error not exceeding ±1%.
• Weight monitoring system: Calibrated with certified test tablets within ±0.5% tolerance.
• Turret speed encoder: Readout matches handheld tachometer within ±1 rpm.

Any discrepancy outside these reference limits requires investigation and may halt further qualification until resolved.

Computerized System Verification and Data Integrity

Modern double rotary tablet presses frequently utilize advanced Human Machine Interface (HMI) control panels integrated with PLCs or SCADA systems. Where automation or data recording is involved, data integrity controls must be specifically tested during OQ:

• User role management: Verify differentiation of permissions for Operator, Supervisor, and Admin roles; test login, password change, and lockout features.
• Audit trail: Simulate parameter changes and confirm unalterable audit log entries containing date, time, user, and action.
• System clock: Check time synchronization with site server; test accuracy and time stamp integrity.
• Data backup & restore: Execute routine backup, simulate a failure, and restore complete configuration and batch data sets without loss.

Example data integrity acceptance criteria may include:

• Audit trail captures parameter changes within 5 seconds, showing exact user identity
• Only Admin can delete user accounts or change system time
• Data backup proven restorable < 30 minutes with full integrity verified

GMP Controls During Operational Qualification

Adherence to GMP controls is critical to ensuring data reliability, traceability, and regulatory compliance during double rotary tablet press validation. The OQ phase integrates the following controls:

• Line Clearance: Before commencing OQ, the area and equipment must be confirmed as clean and free from previous product or material (documented with checklists and supervisor sign-off).
• Status Labeling: Equipment should display a visible status label (e.g., “Under Qualification”) throughout OQ, updated immediately upon changes.
• Logbooks: Each significant event (start/stop, alarm, maintenance action) and test activity must be recorded by the qualification team in the equipment logbook.
• Batch Record Integration: For systems with electronic batch records (EBR), ensure test runs and OQ activities generate correct entries in the batch record system, with clear linkage to test data and QA review trails.

OQ and Data Integrity Checklist for Double Rotary Tablet Press

Environmental, Health, and Safety (EHS) and Compliance Features

EHS compliance is intrinsic to the OQ of double rotary tablet presses. The following features require explicit verification:

• Physical guarding: All moving parts (turrets, punches, feeders) must be shielded with tamper-proof covers. Guards should trigger safety interlocks if opened.
• Pressure relief systems: Devices must engage at specified limits (e.g., 120% of maximum routine compression force) to prevent mechanical overload.
• Emergency stop switches: E-Stops should be present at all operator stations, readily accessible, marked, and function-checked.
• Noise and dust containment: Verify the integrity of dust extraction ports and sound-insulating enclosures as per equipment design and plant EHS criteria.

Appropriate documentation of EHS features, inspection records, and OQ test outcomes are retained within the validation report and accessible for regulatory audits.

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

Performance Qualification for Double Rotary Tablet Presses

Performance Qualification (PQ) is a critical phase in the validation lifecycle of a double rotary tablet press within Oral Solid Dosage (OSD) manufacturing. The aim is to demonstrate consistent, reproducible production under normal and worst-case conditions, thereby ensuring the equipment reliably produces tablets that meet predetermined quality attributes. PQ not only confirms the operational envelope established in Operational Qualification (OQ) but also includes practical, shop-floor runs using actual product formulations and batch sizes.

PQ Strategy: Routine and Worst-Case Scenarios

PQ studies for a double rotary tablet press should encompass both typical (routine) and extremity (worst-case) operational scenarios. Routine PQ involves running the press across its established speed, compression force, and fill depth ranges with normal product blends. Worst-case PQ typically challenges the equipment by using blends with the most challenging properties (e.g., poorest flow, highest dust generation), smallest and largest punch sizes, highest and lowest turret speeds, and longest production runs.

• Routine PQ: Uses standard product and batch size; validates typical operating parameters.
• Worst-Case PQ: Selects product with most challenging characteristics, runs at extremes of compression and speed.

Sampling Plans and Acceptance Criteria

Sampling during PQ should be representative of the entire batch, equipment output, and process variations (e.g., start/mid/end, turret stations, multi-point time-based sampling). The acceptance criteria are derived from product specifications and process capability studies established during development.

Repeatability and Reproducibility

Executing PQ runs a minimum of three times under identical conditions (replicate batches) is standard to demonstrate repeatability and equipment/process robustness. For double rotary tablet presses, monitoring multiple stations ensures reproducibility across all punches and dies, verifying no systemic variation or mechanical bias.

PQ, Cleaning Validation, and Cross-Contamination Controls

As double rotary tablet presses directly contact product, robust cleaning and cross-contamination controls are indispensable. PQ typically links with cleaning validation by running product-changeover scenarios between PQ runs. This demonstrates that validated cleaning SOPs can reliably remove residues and reduce carry-over risk between products. Swab and rinse samples from product-contact surfaces are typically analyzed for API residues, detergent residues, and microbiological contaminants. Acceptance criteria are based on health-based exposure limits (HBELs), visual cleanliness, and established limits for the equipment.

Cross-contamination risk assessments must be revisited after PQ, especially when worst-case products or excipients are used. Verify that dust extraction, machine containment, and cleaning protocols effectively mitigate transfer between product campaigns on the same press.

Continued Process Verification and Ongoing Qualification

Validation is not a one-time activity; after initial PQ, a strategy for continued process verification (CPV) must be established for the double rotary tablet press. This may include:

• Statistical trending of critical process parameters (weight, hardness, turret speed).
• Periodic requalification (e.g., annually or after significant downtime).
• Enhanced sampling during initial commercial production (Stage 3 process validation; per FDA/EMA guidelines).
• Automated or operator-driven in-process controls with documented review of process data.

Deviations from established control limits, recurring minor failures, or process drifts can be signals for targeted requalification or corrective actions.

SOPs, Training, Preventive Maintenance, Calibration, and Spares

Sustained validated status for a double rotary tablet press depends on an integrated site quality system:

• SOPs: Detailed, equipment-specific SOPs must cover setup, operation, cleaning, lubrication, breakdown response, and calibration. These must reflect validated settings, product changeover instructions, and pass/fail criteria.
• Training: Only trained and qualified personnel should operate or maintain the press. Training records should link to validation data and cover routine operation, troubleshooting, and cleaning techniques specific to this make/model.
• Preventive Maintenance: Regular PM activities should be defined for turrets, punches, dies, compression rollers, sensors, dust collection, and critical safety interlocks. Maintenance logs support the ongoing control strategy.
• Calibration: All measurement devices (e.g., weight feedback, pressure sensors, tablet counters) must be calibrated on a defined schedule, and calibration status should be visible on equipment.
• Spares: A risk-based spare-parts inventory should be maintained for high-wear components—punches, dies, seals, electrical fuses, and sensors.

Change Control, Deviations, and CAPA Linkage

Any changes that impact the validated state of the double rotary tablet press, its settings, software, or major wear parts must undergo formal change control. This includes:

• Hardware or software updates/modifications
• Major repairs or replacement parts (e.g., new turret, sets of punches and dies)
• Changes to cleaning agents or procedures
• Altered product types or significantly different formulations

Deviations during PQ (e.g., OOS weight, compressed tablet sticking, mechanical faults) require documented investigation and risk assessment. Corrective and preventive action (CAPA) processes should robustly address root cause, and may lead to partial or full requalification of the equipment depending on the nature/impact of the issue.

Triggers for requalification may include recurring deviations, major process or equipment changes, equipment relocation, or after a prolonged period of inactivity.

Validation Deliverables: Protocols, Reports, and Traceability

All phases of double rotary tablet press validation require robust documentation, typically including:

• PQ Protocol: Defines scope, test plan, acceptance criteria, sampling methods, data recording templates, and criteria for success/failure.
• PQ Report: Presents execution data, deviations, investigations, statistical analyses, and overall summary (with clear statement of equipment fitness).
• Summary/Final Validation Report: Compiles DQ/IQ/OQ/PQ, risk assessments, deviations/justifications, and lifecycle recommendations.
• Traceability Matrix: Cross-references requirements through specification/design/protocol/report, ensuring complete coverage and auditability.

These records must be archived in compliance with data integrity standards and be readily available for regulatory or internal review.

Frequently Asked Questions (FAQ) about Double Rotary Tablet Press Validation

What are the unique qualification challenges of double rotary tablet presses?

These presses have numerous stations (punches/dies) and high throughput, making uniformity and reproducibility across all stations essential. Synchronizing both turrets and verifying all stations requires comprehensive PQ sampling.

How often should PQ be repeated for a double rotary tablet press?

PQ should be repeated after any major change to the equipment or process, or at a defined interval based on risk (commonly one to three years), and whenever issues are encountered that suggest process drift or equipment malfunction.

Is cleaning validation required for every product?

Not always. Typically, a matrix approach is used, identifying worst-case products by cleaning difficulty or potency. However, specific products may demand dedicated studies, especially highly active APIs or those prone to adhesion.

What are key signs that requalification may be needed?

Frequent deviations in tablet weight, hardness, or friability; major mechanical failures; and persistent cleaning failures all indicate that the press may require partial or full requalification.

How is change control managed for minor vs. major changes?

Minor changes (e.g., non-product-contact spares) may only require documentation and risk assessment, while major changes (e.g., turret replacement) demand full change control with impact assessment and potentially new validation runs.

What is the difference between PQ and routine validation sampling?

PQ is a formal, time-bound study to demonstrate repeatability/reproducibility under specified conditions. Routine sampling is an ongoing GMP activity for batch release, but is less extensive and typically follows established SOPs.

Does software upgrade require revalidation?

Any change to software (e.g., HMI, SCADA, control algorithms) that could impact data integrity, compliance, or critical operation parameters must undergo change control and be assessed for partial or complete requalification.

Conclusion

Implementing a robust double rotary tablet press validation program is fundamental to ensuring product quality and regulatory compliance in oral solid dosage manufacturing. By establishing disciplined PQ strategies, integrating cleaning validation, linking equipment maintenance and calibration, and supporting every activity with comprehensive procedures and documentation, facilities can maximize process control, minimize contamination risks, and sustain equipment qualification status. Ultimately, this integrated approach supports both regulatory expectations and manufacturing performance, ensuring high-quality tablets and a successful validation lifecycle.