Double Rotary Tablet Press Operational Qualification (OQ)

The double rotary tablet press is a cornerstone technology in the manufacturing of oral solid dosage forms such as tablets. Designed for high-output environments, it rapidly compresses granulated material into uniform tablets utilizing two sets of rotary punches and dies. Its continuous production capability, coupled with in-process control provisions, positions the double rotary tablet press as a critical asset in modern pharmaceutical operations. Understanding the operational qualification (OQ) of this equipment is crucial to ensure robust performance, batch-to-batch consistency, and regulatory compliance.

Role of the Double Rotary Tablet Press in the Oral Solid Dosage Process

Positioned downstream of the blending and granulation stages, the double rotary tablet press transforms uniform granulated blends into final dosage forms. It can accommodate a wide range of tablet sizes, shapes, and formulations, making it highly versatile. Its intended use boundaries are defined by:

• Compressing pharmaceutical powder or granulate blends into tablet form
• Operating within specified material attributes (flow properties, compressibility, particle size)
• Supporting automatic tablet ejection and collection systems
• Integrating with in-process control systems for weight, thickness, and hardness measurements
• Operating within predefined environmental and occupational safety boundaries

The equipment is not intended for non-pharmaceutical products, products prone to high cross-contamination risk (e.g., potent or cytotoxic drugs without dedicated containment), or non-tablet oral dosage forms (capsules, softgels).

Validation Scope and Boundaries for Double Rotary Tablet Press OQ

A well-defined scope ensures that the operational qualification rigorously demonstrates the press’s fit for intended pharmaceutical application, while also clarifying activities that fall outside the OQ remit. For a double rotary tablet press, the typical OQ scope includes:

• Verification of operational functions (routine and safety operations)
• Testing alarm and interlock performance
• Assessment of critical parameter ranges (compression force, turret speed, fill depth)
• Evaluation of Human-Machine Interface (HMI) and control software performance
• In-process sample collection features and data recording
• Assessment of cleaning and changeover procedures (if applicable to operation)
• Review of calibration status for integrated sensors and parameter settings

Out of scope for OQ:

• Physical installation checks (covered in Installation Qualification, IQ)
• Product-specific performance runs (addressed in Performance Qualification, PQ)
• Maintenance protocols validation
• Long-term reliability and wear-and-tear studies
• Qualification of upstream/downstream auxiliary systems (e.g., HVAC, dedusters)

Criticality Assessment: Risks Inherent in Double Rotary Tablet Press Operations

Double rotary tablet presses present several potential risks to product quality, patient safety, and data integrity, making their qualification paramount. A comprehensive criticality assessment covers:

• Product Impact: Inconsistent compression force or fill depth might yield tablets that do not meet hardness or content uniformity specifications.
• Patient Risk: Failing to detect defects (capping, lamination, inaccurate dose) could result in suboptimal therapy or adverse events.
• Data Integrity: Automated data capture and reporting must be reliable, with ensured audit trails, to maintain traceability and meet regulatory standards.
• Contamination Risk: Inadequate cleaning or faulty equipment seals could introduce cross-contaminants or foreign particulates into the product.
• EHS Risk: Machine guarding, noise levels, and dust containment features are essential to protect operator health and safety.

GMP Expectations for Double Rotary Tablet Presses

Good Manufacturing Practices (GMP) set clear standards for equipment used to manufacture medicinal products for human use. For double rotary tablet presses, critical GMP expectations encompass:

• Consistent Output: The press must operate reliably at specified speed and pressure settings while producing tablets within approved specifications.
• Control and Traceability: HMI, batch records, and electronic data must be complete, accurate, and protected from unauthorized changes.
• Cleanability: Equipment design should minimize crevices and allow effective routine cleaning to prevent product carryover or cross-contamination.
• Changeover Capability: Systems should support rapid, documented changeovers with minimal risk of mix-ups.
• Calibration and Maintenance: All sensors and critical controls must be regularly calibrated and maintained to ensure reliable operation.

User Requirements Specification (URS) for Double Rotary Tablet Presses

A robust User Requirements Specification (URS) guides both procurement and qualification activities. It articulates the minimum functional, performance, and compliance criteria for the equipment. URS for a double rotary tablet press should include (but is not limited to):

• Capacity and Throughput Requirements: Minimum and maximum tablet size/weight, batch volumes, speed (tablets/hour)
• Critical Process Controls: Compression force, fill depth control, speed regulation
• Automation and Data Integration: Details of HMI requirements, electronic audit trails, data export functions
• Cleaning and Access: Fully accessible parts for cleaning, ease of disassembly/reassembly without special tools
• Compliance and Safety: CE/UL certification, interlock systems, dust extraction compatibility

Example URS Excerpt:

• Maximum turret speed: 55 RPM
• Minimum compression force: 2 kN
• Number of stations: 45
• Integrated weight control with auto-reject for out-of-spec tablets
• 21 CFR Part 11 compliant electronic records and audit trails
• All product-contact parts manufactured from AISI 316L stainless steel

Risk Assessment Foundations for OQ Planning

An effective OQ protocol is shaped by a risk-based approach, focusing efforts where failures would most significantly impact product quality or patient safety. Applying Failure Modes and Effects Analysis (FMEA) principles to the double rotary tablet press, typical risk considerations include:

• Compression Force Out of Range: Tablets too soft (risk: dissolution failure) or too hard (risk: disintegration, swallowability)
• Filling System Malfunction: Dose variability, risk to label claim
• Sensor Failure: Undetected process deviations, data gaps
• Interlock Bypass: Increased EHS risk (operator exposure to moving parts)
• Data Loss or Tampering: Loss of batch record integrity, regulatory non-compliance

For each risk, the OQ should define targeted functional tests and acceptance criteria.

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

Establishing a Robust Supplier Control and Qualification Approach

The foundation of an effective double rotary tablet press OQ (Operational Qualification) program begins with stringent supplier control. Selecting a qualified vendor impacts equipment compliance, lifecycle reliability, and ease of validation. For such critical GMP machinery, supplier assessment should rigorously evaluate both manufacturing capabilities and documentation standards.

Vendor Qualification

Vendor qualification for tablet presses involves a structured process:

• Quality Management System (QMS) Evaluation: Confirm the vendor maintains a certified QMS (e.g., ISO 9001:2015), including documented SOPs for equipment manufacturing, inspection, and change control.
• Technical Competence: Assess history with similar pharmaceutical OSD (Oral Solid Dosage) equipment, documented training of personnel, and after-sales support provision.
• Audit and Pre-Approval: Conduct on-site audits or remote assessments to review production controls, calibration practices, and previous regulatory findings.

Supplier Document Package Requirements

The double rotary tablet press document package must support traceability, regulatory compliance, and subsequent validation steps. An optimal supplier documentation bundle includes:

• Material Certificates: For all direct product contact parts (e.g., turret, punches, dies, feeders), include 3.1 MTCs per EN 10204 or equivalent, confirming grade, heat number, and traceability.
• Mechanical Drawings and Schematics: As-built engineering drawings, including GA (general arrangement), part lists, electrical and pneumatic diagrams.
• Software Documentation (if applicable): For presses with HMI/PLC controls, require configuration settings, logic descriptions, and software version control logs. Source code may be secured if agreed under confidentiality.
• Certificates of Origin & Compliance: Declaration of conformity to applicable directives (e.g., CE mark), FDA food-grade compliance certificates for elastomers/gaskets.
• Assembly & Commissioning Records: Inspection and test records from manufacturing and any factory pre-assembly runs.
• Operation and Maintenance Manuals: Detailed instructions for set-up, calibration, troubleshooting, and cleaning.
• Calibration Certificates: For integrated instrumentation such as pressure/vacuum gauges, weighing systems, torque wrenches used in assembly.

Checklist: Supplier Documentation and Qualification Deliverables

Factory and Site Acceptance Testing (FAT/SAT) Strategy

Thorough acceptance testing of the double rotary tablet press is essential to verify utility, safety, and functional compliance prior to full-scale qualification onsite.

Factory Acceptance Test (FAT)

• Scope: FAT covers core mechanical operations, safety interlocks, PLC/HMI functionality, basic compression runs (dummy or actual product), and utility simulation.
• Test Elements:
  • Operation of main drive and turret rotation
  • Punch and die alignment checks
  • HMI display functions, alarms, emergency stops
  • Compression force feedback—sensor signal test
  • Changeover procedures for quick cleaning evaluation
• Witnessing and Reporting: End-user validation, engineering, QA, and possibly a third-party inspector should be present. Observations, deviations, and resolution steps are recorded in controlled FAT protocols. Document photos/videos, and attach all deviation closeout actions.

Site Acceptance Test (SAT)

• Re-verification: On-site SAT confirms as-shipped condition, re-assembly integrity, and utility compatibility at the installation site.
• Scope:
  • Machine reassembly cross-checked with as-built drawings
  • Verification of connected utilities (power, compressed air, vacuum)
  • Alarm and interlock test under site-specific scenarios
  • Initial empty and then product-based dry runs
• Deviation Handling: All test discrepancies are formally logged, root-cause analysis performed, and corrective action tracked to closure prior to OQ lot runs.

Design Qualification (DQ) Milestones for Tablet Press Validation

DQ ensures that the procured double rotary tablet press meets predefined functional, regulatory, and user criteria as documented in the URS (User Requirement Specification). The DQ phase involves systematic assessment of the press’s specification against process needs and GMP standards.

• Design Document Review: Cross-check all user requirements versus vendor technical files—dimensions, output capacity, control modes, and safety features.
• Drawings & Specification Approval: Approve general arrangement, part detail, material certificates, and surface finish standards for product contact items (e.g., SS304/316 with specified Ra finish).
• Material of Construction: Validate that direct-contact materials (compression zone, chutes) are corrosion-resistant and suitable for intended cleaning agents. Ensure gaskets/seals are compatible with all products and detergents.
• Hygienic / Sanitary Design: Assess cleanability, and inspect for dead legs, unsealed horizontal surfaces, and crevices. Confirm the drainability and accessibility for swab/rinse sampling as per GMP and EHEDG guidelines.
• Functional and Safety Review: Verify logic diagrams, safety relay wiring, emergency disconnects, and interlocks for turret guards and ejection chutes.

Installation Qualification (IQ): Planning and Execution

The IQ phase transitions the double rotary tablet press from delivery to an installed, validated asset. IQ protocols should be pre-approved, risk-based, and harmonized with the site’s engineering and quality frameworks.

IQ Checks and Documentation

• Location & Foundation: Confirm placement aligns with approved plant layout; assess physical anchoring/leveling as per vendor specs.
• Utility Connection Verification: Methodically check:
  • Power supply—voltage, phase and earthing within tolerances (e.g., 400V ±10%, 50Hz, 3-phase with dedicated earthing)
  • Compressed air—pressure, dewpoint, filtration (oil-free, 6 bar min, 0.1 μm filter per machine requirements)
  • Vacuum—flow rates adequate for encapsulated dust extraction
  • Process water (if clean-in-place functions exist)—ensure RO or PW/PUW quality, stagnation avoidance
  • HVAC—qualified environment, e.g. ISO8 or Class D or better, temperature/humidity controlled and monitored
• Instrumentation & Calibration: Check all integrated measurement devices for valid, traceable calibration status; labels and certificates should match instrument IDs.
• Component Verification: Confirm all critical and ancillary parts have been supplied, installed, and verified against the parts list.
• Identification/Labeling: Equipment tagged with unique ID, flow direction, safety hazard symbols, and do-not-operate signs until OQ clearance.
• As-Built Documentation: Dossier includes signed-off installation checklists, utility hook-up lists, as-built drawings, part certificates, and maintenance logs.
• Safety and Housekeeping: Inspect all guards, barriers, emergency stops, warning labels, e-stops, enclosure integrity, and area clearance.

IQ & DQ Acceptance Criteria: Traceability Matrix Example

Environmental and Utility Preconditions

The operational reliability and GMP fitness of a double rotary tablet press are tightly linked to its supporting environment and utilities. Pre-qualification approval hinges on documented, quantified conformance to the following:

• HVAC Class: The press should operate within a classified area matching product risk—typical OSD production areas demand ISO8/Class D or better with validated air handling, pressure differentials ≥10 Pa, and controlled temperature (20–25°C) and humidity (≤60% RH).
• Compressed Air: Direct contact or purge air must be free from oil, particulates, and microbiological contamination. Inline filters (0.1μm or better), pressure regulation, and dewpoint monitoring (<-40°C) are mandatory; logs reviewed in IQ and OQ.
• Purified Water (PW/PUW) or RO Water: Required if product or punch lubrication interfaces with water. Must meet relevant pharmacopeial standards and avoid cross-contamination; distribution validated for micro and endotoxin limits.
• Electrical Power Quality: Confirm stable, spike-free supply within the machine’s tolerance—phase monitoring relays, earth leakage detection, and ground continuity must be verified and records filed.
• Clean/Service Steam (if required): For presses with integrated cleaning or heat-based tooling, ensure steam meets clean utility standards—filtered, condensate-free, with temperature/pressure monitoring.

Acceptance criteria for each utility and environmental parameter must be documented in the qualification protocol, and utility logs incorporated into the batch record or OQ report. Deviations from specified standards demand CAPA (Corrective and Preventive Actions) before routine OSD production.

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

Operational Qualification (OQ) of a Double Rotary Tablet Press

Operational Qualification (OQ) ensures that the double rotary tablet press consistently functions according to the process requirements and defined parameters under simulated operating conditions. OQ is pivotal in confirming that all controls, instrumentation, safety interlocks, and process parameters perform as intended, securing the reliability, repeatability, and integrity demanded by Good Manufacturing Practice (GMP) regulations for oral solid dosage form production.

1. Functional Tests and Operating Ranges

During OQ, the double rotary tablet press is subjected to comprehensive functional testing. Each operating mode and major function is exercised and observed for correct performance in alignment with the equipment’s design and user requirements specification (URS). These operational test cases include:

• Main Drive Operation: Confirm smooth start, steady-state running, speed control, and accurate speed indication over the full specified range (e.g., 10–60 rpm*).
• Feeder System: Verify proper feeding and agitation at various hopper fill levels, ensuring uniform material flow to die cavities.
• Compression Force Controls: Assess low and high compression force setpoint responses. Tablet press should maintain selected pre-compression (e.g., 2–5 kN*) and main compression (e.g., 10–80 kN*) forces within defined tolerances (±5%*).
• Tablet Ejection: Evaluate tablet discharge, adjust for different formats, and check for jam-free operation throughout the batch cycle.
• Lubrication System: Verify functioning of automatic lubrication pumps, proper pressure, and alarm interlocking.

*Sample values provided as illustrative acceptance criteria; actual ranges subject to equipment/model specification.

2. Setpoint Verification and Challenge Tests

OQ rigorously challenges each key process setpoint by adjustment to operating limits, followed by system verification:

• Speed, pressure, and dwell time adjustments are subjected to incremental changes, ensuring the HMI/SCADA accurately reflects setpoint inputs and actual values. The process response is validated for stability without alarms or unexpected behavior.
• Challenge tests—such as simulated power loss, hopper refill, or temporary over-pressure—are performed to confirm robust system recovery and proper trigger of alarms and interlocks.

3. Instrumentation Checks and Calibration Verification

Instrumentation used to monitor or control the tablet press is thoroughly assessed during OQ. This includes pressure transducers, load cells (for compression force), speed encoders, and temperature or humidity sensors (where applicable). Key OQ actions:

• Calibration Verification: Recorded calibration status is confirmed to be within due date. Spot checks at operating points are performed using certified traceable standards; deviations must remain within allowable tolerances (e.g., force sensor ±1%*).
• Display/Readout Cross-Check: Digital readouts on the HMI and any ancillary displays are compared with manual or reference measurements for consistency.
• Alarm System for Instrumentation Failure: Simulate disconnection or out-of-range signals to ensure the system responds with appropriate error messages and process stoppage as per safety design.

*Example tolerance; confirm per site SOP and URS.

4. Data Integrity Controls for Computerized/Automated Systems

Where the double rotary tablet press integrates PLC, SCADA, or standalone control systems, data integrity is a GMP critical control point:

• User Roles and Access Rights: OQ verifies that only qualified personnel can access, operate, or change setpoints, through unique logins and well-defined roles (e.g., Operator, Supervisor, Engineer).
• Audit Trail Functionality: Confirm that every critical operation—including setpoint changes, alarm overrides, maintenance access, and batch start/stop—is recorded in a non-editable, time-stamped audit trail. Attempts to alter records should be denied and logged.
• System Time Synchronization: System clock synchronizations are checked with site reference clocks. Time drift limits might typically be strict (e.g., <2 minutes per month*).
• Data Backup and Restore: Backup and restore functions are challenged to ensure all critical operational data, recipes, and audit logs can be restored to the system without data loss.

Data integrity compliance is further verified by attempting to perform unauthorized actions, reviewing rejected attempts, and ensuring failed logins or unexpected actions are properly captured.

5. GMP Controls and Documentation

GMP compliance within the OQ stage centers on operational controls, system documentation, and status management:

• Line Clearance: Documented checks of the equipment and surrounding line area occur prior to OQ, ensuring no residual material or labels from prior activities are present.
• Status Labeling: Clear “UNDER QUALIFICATION” or “NOT IN USE” labels are affixed to the double rotary tablet press to alert personnel to non-production status during OQ.
• Logbook Use: Each test activity, observed alarm, parameter change, and system intervention is logged in the equipment logbook with initials, date, and reference to OQ protocol section.
• Batch Record Integration: All validated setpoints, instrument IDs, user roles, and output test results are cross-referenced for integration into the standard production batch record template, supporting traceability and audit readiness.

6. Safety, Environmental, and Compliance Features

The OQ protocol verifies all physical and system safety mechanisms on the double rotary tablet press, including:

• Guard Interlocks: All access panels, hoppers, and safety shields are tested for proper operation and loss-of-signal simulation. Attempted operation with a guard open must trigger system shutdown and a clear alarm.
• Pressure Relief and Dust Extraction: Safety relief valves and collection systems are challenged for correct activation in abnormal pressure or dust overload scenarios.
• Emergency Stop Functions: Every emergency stop button is tested at each location; the press must halt instantly and not restart until proper reset and acknowledgement.
• Noise, Vibration, and EHS: Compliance with operator environmental health and safety (EHS) limits is assessed using calibrated meters. Typical example limits: Noise <85 dB(A)* at operator positions; vibration <2.5 m/s²* at hand contact points.

*Dummy acceptance criteria for illustration—actual thresholds may vary by model and site EHS standards.

7. OQ Execution & Data Integrity Checklist (Sample)

This checklist should be tailored for the specific double rotary tablet press make and model, with documented results and objective evidence supporting each acceptance within the OQ protocol.

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

Performance Qualification (PQ) for Double Rotary Tablet Press

The Performance Qualification (PQ) phase is critical in establishing documented evidence that a double rotary tablet press consistently operates within predetermined specifications under routine and worst-case production scenarios. PQ not only verifies operational effectiveness but also assures product integrity for oral solid dosage forms, such as tablets.

PQ—Routine and Worst-Case Strategies

During PQ, the tablet press is evaluated using representative product formulations. Scenarios must be designed for both routine and worst-case conditions. Worst-case runs include batches at upper and lower weight limits, maximum turret speed, minimum tablet size, and extremes of environmental conditions (e.g., highest humidity or temperature within the validated range). These stresses help demonstrate that the press maintains quality performance even at operational boundaries.

PQ Sampling Plans

A scientific and risk-based sampling plan is essential. Samples are typically collected at multiple stages: start-up, steady-state (at intervals), and shut-down. Sampling should cover output from all tablet stations, ensuring uniformity across turrets and compression rollers. Sampling locations and sizes must align with statistical and regulatory expectations.

Repeatability and Reproducibility

The PQ protocol requires at least three consecutive successful production runs, each meeting all acceptance criteria. This demonstrates the repeatability and reproducibility of the double rotary tablet press under defined equipment, operator, and process variables.

PQ, Cleaning Validation, and Cross-Contamination Controls

As a product-contact machine, the double rotary tablet press is subject to cleaning validation and verification requirements. PQ cycles must include at least one cleaning verification (post-product run) to ensure cross-contamination risks are controlled. Swab and rinse sampling from direct-contact parts (e.g., dies, punches, feed frame) should demonstrate residues are within established safety limits. PQ data, when integrated with cleaning validation, confirm the effectiveness of routine cleaning SOPs and allow determination of suitable cleaning frequencies and parameters for continued operation.

Continued Process Verification & Qualification Maintenance

Once PQ is complete, Continued Process Verification (CPV) encompasses routine monitoring throughout the equipment’s lifecycle. Key elements include:

• Trending of process critical parameters (e.g., compression force, turret speed, feeder performance)
• Periodic review of product quality attributes against specifications
• Scheduled review of OEE (Overall Equipment Effectiveness) and deviation histories
• Routine cleaning and product changeover checks with periodic analytical verification

The CPV program ensures the validated state is continuously demonstrated. Triggers for requalification include major repairs, significant changes (hardware, software), or recurring deviation patterns.

SOPs, Training, Preventive Maintenance & Calibration

Robust Standard Operating Procedures (SOPs) underpin operational controls. Critical SOPs include:

• Setup, start-up, and shutdown procedures for the double rotary tablet press
• Routine in-process checks (weight, thickness, hardness measurements)
• Cleaning, sanitation, and changeover procedures
• Preventive maintenance schedules, including checks for punch/die wear, lubrication, and sensor/switch function
• Calibration of instrumentation (load cells, thickness gauges, feeders) with traceable standards
• Management and inventory of essential spare parts

Operators, maintenance, and QA staff must be trained and qualified on these procedures, with records maintained per cGMP requirements. Preventive maintenance and calibration logs support both ongoing qualification and inspectional readiness.

Change Control, Deviations, CAPA, and Requalification

Any proposed change relating to the double rotary tablet press—including software updates, hardware replacement, process parameter adjustments, or cleaning regimen modifications—must be managed through a formal Change Control process. Impact assessment must consider whether requalification (partial or full) is warranted based on the potential to affect GMP compliance or validated status.

Deviations identified during PQ or routine operation should be traced, investigated, and linked to Corrective and Preventive Actions (CAPA). Root cause analysis ensures that systematic failures are addressed and documented, supporting a state of control for both quality and regulatory requirements.

Validation Deliverables

Deliverables for the double rotary tablet press OQ/PQ include:

• PQ Protocol: Pre-approved document detailing test parameters, sampling plans, acceptance criteria, and responsible personnel.
• PQ Execution Records: Raw data, completed test forms, logs, and calibration certificates generated during qualification batches.
• PQ Summary Report: Comprehensive document compiling results, deviation assessments, acceptance status, conclusions, and recommendations. Must map all critical tests back to the protocol via a traceability matrix.
• Traceability Matrix: Ensures traceable linkage among user requirements, test scripts, results, and acceptance conclusions—addressing regulatory expectations for data integrity.
• Final Validation/Qualification Summary Report: Optional higher-level document aggregating PQ with prior IQ and OQ findings, deviations, CAPA implementation, and overall qualification status.

Frequently Asked Questions (FAQ)

What are common worst-case scenarios during double rotary tablet press OQ/PQ?

Worst-case tests include using the lowest and highest compressible tablet weights, operating at both the maximum and minimum turret speeds, and running the press with the smallest and largest tablet tooling allowed. Testing low bulk density granules or highly abrasive formulations often represents challenging product characteristics.

How is cleaning validation integrated with PQ for this equipment?

PQ cycles typically end with a thorough cleaning verification. Swab samples are analyzed for residual actives and detergents, confirming cleaning procedures effectively mitigate cross-contamination risks. Validation includes establishing acceptance limits based on toxicological and product carryover assessments.

What are the requalification triggers for a validated double rotary tablet press?

Triggers include major hardware replacements (turret, compression stations, control system), significant software updates, process parameter changes, or persistent/critical deviations suggesting the validated state may have been compromised.

How frequently should the press be calibrated and maintained?

Calibration intervals are set based on manufacturer recommendations, process criticality, and historical performance—commonly every 6 to 12 months. Preventive maintenance is performed in accordance with risk-based schedules, typically monthly and annually, with checks on punches/dies, lubrication, sensors, and safety devices.

What happens if a PQ batch fails to meet acceptance criteria?

Failure triggers a documented deviation and investigation. Root cause analysis guides necessary corrective actions before re-executing affected PQ tests. Only successfully completed PQ batches are included in the final validation report.

How does CPV differ from initial qualification?

Initial qualification (IQ/OQ/PQ) is a one-time activity for bringing new equipment into service, whereas Continued Process Verification (CPV) is an ongoing program to ensure validated performance is maintained throughout the equipment lifecycle.

Must all test equipment be calibrated before PQ runs?

Yes. All analytical instruments, weight balances, hardness testers, and other devices used during PQ testing must have valid calibration status documented to ensure measurement reliability and traceability.

Conclusion

Operational Qualification (OQ) and Performance Qualification (PQ) for a double rotary tablet press are foundational to achieving a state of GMP control in oral solid dosage manufacturing. Leveraging robust sampling plans, integrating cleaning validation, maintaining strict documentation, and ensuring comprehensive lifecycle management ensures process consistency, regulatory compliance, and patient safety. Ensuring all support systems—training, SOPs, maintenance, calibration, and change control—function as an integrated whole fortifies the validated status of the equipment for reliable, high-quality tablet production.