Single Rotary Tablet Press Performance Qualification (PQ)

Single Rotary Tablet Press PQ: Performance Qualification for Oral Solid Dosage Forms

The single rotary tablet press is a core piece of GMP manufacturing equipment, specifically designed for the compression of powder blends into uniform tablets within the oral solid dosage (OSD) production process. Its compact footprint, reliability, and ease of operation make it the favored solution for batch production in both R&D and commercial settings. Ensuring robust single rotary tablet press PQ (Performance Qualification) is critical for confirming that the equipment consistently produces tablets meeting predefined quality and performance specifications under routine operating conditions.

Understanding the Single Rotary Tablet Press in OSD Manufacturing

In the manufacturing flow for tablets, the rotary tablet press sits after blending and granulation, directly preceding any dedusting, coating, or packaging steps. Its function is to compress measured amounts of powder or granulate into tablets of consistent weight, thickness, and hardness. It is designed to operate using a rotating turret fitted with a predetermined number of punches and dies, enabling the mass production of tablets with precise control over compression force and dwell time.

The intended use boundaries for a single rotary tablet press include:

• Processing specified formulations qualified during development
• Operation within manufacturer-recommended limits for speed, fill depth, and compression force
• Production of tablet shapes and sizes commensurate with the equipment’s turret and tooling design
• Use with non-hazardous, free-flowing powders (unless designed for potent/cytotoxic containment)

Validation/Qualification Scope

The Performance Qualification (PQ) of a single rotary tablet press demonstrates, with documented evidence, that the equipment can operate within defined process parameters to consistently yield product meeting specification in an actual production environment.

In Scope:

• Verification of tablet physical quality (weight, thickness, hardness, friability, etc.) during extended production runs
• Assessment of process variability and reproducibility under normal and boundary operating conditions
• Compliance with predefined operational limits and alarms (press speed, compression force, ejection force)
• Data integrity verification for electronic records if equipped
• Performance under conditions representative of routine cleaning and changeover

Out of Scope:

• Mechanical qualification and initial installation checks (addressed via IQ/OQ)
• Validation of environmental conditions (HVAC, controlled areas) not directly tied to press PQ
• Downstream processing (e.g., tablet coating or packaging) beyond demonstration of in-spec tablet output
• PEMS/automation network qualification (unless directly linked to control and data capture)

Criticality Assessment: Product and Patient Risk Landscape

The single rotary tablet press has a direct role in determining the critical quality attributes (CQAs) of the final oral solid dosage product. Its criticality can be evaluated against several risk domains:

• Product Impact: Incorrect press settings or malfunctions can cause out-of-specification (OOS) tablet weight, hardness, or content uniformity, directly affecting product efficacy and patient safety.
• Patient Risk: Double compression, tablet lamination, or capping may introduce non-uniform dosing; undetected failures could expose patients to overdose or subtherapeutic dose.
• Data Integrity Impact: For computerized presses, data integrity failures (in record generation or storage) can compromise batch traceability and release decisions.
• Contamination Risk: Cross-contamination can occur due to inadequate cleaning or improper changeover procedures. Trapped powder and tooling residues are major risk sites.
• EHS Risk: Improper use or bypass of safety interlocks can expose operators to pinch points, moving parts, or dust containment failures.

Key GMP Expectations for Single Rotary Tablet Presses

Regulatory expectations center on consistency, traceability, and control:

• The press must be validated as suitable for the intended process and routinely produce product that meets defined specifications
• Changeover, cleaning, and maintenance protocols must ensure no carryover between batches/formulations
• Any critical parameter (e.g., compression force, press speed) must be annually calibrated and controlled, with limits enforced and alarms set
• If equipped with electronic controls or recorders, audit trails and data integrity features are required, and must be appropriately validated
• All critical settings should be locked or access-controlled (passwords/keys), minimizing risk of unauthorized changes
• Deviations and alarms must be captured and acted upon per documented procedures

User Requirement Specification (URS) Approach for Single Rotary Tablet Press

Drafting an effective URS is foundational for ensuring equipment selection, qualification, and long-term compliance. The URS for a single rotary tablet press should capture:

• Process Capability: Range of tablet weights, sizes, shapes, and production batch volumes
• Materials Compatibility: Types of APIs/excipients, cleaning regimes, potential for potent compound operation if applicable
• Control Systems: Requirements for press monitoring, recipe management, and alarm handling
• EHS and Containment: Dust control, safety interlocks, and ergonomic considerations
• Data Integrity: Integration with MES/LIMS, audit trail requirements, electronic batch record compatibility
• Maintenance and Changeover: Tooling compatibility and rapid changeover features

Example URS excerpt:

• Capable of producing round tablets 6–12 mm diameter at up to 60,000 tablets/hour
• Compression force programmable up to 80 kN, accuracy within ±2%
• Must provide automated weight control and sampling every 500 tablets
• Equipped with HEPA-filtered dust extraction and operator interlock system
• Integrated 21 CFR Part 11 compliant data recording with audit trail

Risk Assessment Foundations for Tablet Press PQ Planning

The PQ strategy is shaped by an FMEA-style risk assessment, emphasizing identification and mitigation of potential failure modes that could impact product quality or patient safety. Examples include:

• Out-of-specification tablet weights/fill variation due to feeder issues
• Improper cleaning/changeover leading to cross-contamination between products
• Unrecognized drift in compression force resulting in under- or overhard tablets
• Software or electronic data integrity failures affecting batch data reliability

The risk assessment forms the backbone of the PQ protocol by mapping critical requirements to risk and defining the corresponding control or test. See example below:

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

Supplier Controls for Single Rotary Tablet Press PQ

Robust equipment qualification in GMP environments relies heavily on the assurance provided by supplier controls. For a single rotary tablet press, the supplier’s ability to consistently deliver compliant, documented, and verifiable machinery is critical. Vendor qualification should involve both quality and technical assessments, capturing not only the manufacturer’s capability and track record but also their quality management system, regulatory inspection history, and support for after-sales and validation activities.

The supplier qualification process should establish:

• Audit of vendor’s facility, with focus on GMP-compliance, engineering controls, production practices, and quality systems.
• Review of supplier’s change control procedures, deviation management, and non-conformance resolution mechanisms.
• Evaluation of previous installation references, after-sales service responsiveness, and spare part availability.
• Confirmation of training programs for operators and maintenance staff if included in scope.

Document packages provided by suppliers are core to qualification. For a single rotary tablet press, this package must include:

• Detailed drawings and P&IDs
• As-built specification sheets
• Welding and fabrication certificates where relevant (for product-contact parts)
• Material certificates for all process-contact components (e.g., 316L for contact surfaces), gasket and seal origin/tracking, and elastomer specifications
• Complete list and certification of purchased components (drive motors, gearboxes, sensors, etc.)
• Calibration certificates for all instrumentation supplied with the equipment
• Declaration of conformity (CE/GMP/21 CFR as applicable)
• Operational manuals, preventive maintenance instructions, and troubleshooting flowcharts
• Where software is supplied (for HMI, PLC, or SCADA integration): software functional specifications, version control logs, validation test records, and cybersecurity compliance documentation

Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT)

A well-planned FAT ensures that the single rotary tablet press meets purchasing and regulatory requirements prior to site arrival. FAT typically takes place at the manufacturer’s facility and should include:

• Mechanical, electrical, and control system verification
• Verification of critical components (turret, punches, dies, feeder mechanisms) and their assembly
• Dry run of mechanical operation: rotation speed, lubrication, and alignment tests
• Simulation of basic tablet compression process (without product, unless permitted)
• Inspection of safety functions: emergency stops, guards, and interlocks
• Software interface demonstration (for HMI/PLC systems)

Clients typically witness the FAT, with QA/QC representatives and end users present to observe, ask questions, and sign off results. Any deviations from specifications must be clearly recorded, justified, and a remediation/re-inspection plan agreed upon.

SAT complements the FAT after installation at the user’s site. It may duplicate some FAT tests but under actual site conditions, emphasizing:

• Utility integration (site HVAC, compressed air, power, water)
• Verification of site-specific control and safety interlocks
• Initial full-system runs in the operational environment

Deviations or failures during SAT must be managed under the site’s deviation control process, with corrective actions tracked.

Design Qualification (DQ): Critical Reviews for Tablet Presses

DQ provides documented confirmation that proposed designs meet URS, GMP, and intended process requirements. Key DQ activities for a single rotary tablet press include:

• Review and approval of general arrangement and assembly drawings
• Verification of selected materials of construction for contact and non-contact parts
• Assessment of hygienic design: accessibility for cleaning, smooth surfaces, elimination of dead-legs, drainability, prevention of cross-contamination
• Review of environmental specifications: suitability for operation in designated cleanroom class (e.g., ISO 8 or Class D)
• Safety assessments in design: guarding, access panels, labeling, emergency stops
• Review of control systems: software, automation, data integrity and audit trail capabilities (where applicable)
• Verification of compliance with local and international regulatory requirements

The DQ must be thorough, involving engineering, validation, production, and quality departments for multidimensional assurance.

Installation Qualification (IQ): Planning and Execution Specifics

IQ establishes that the single rotary tablet press is delivered, installed, and configured according to DQ and manufacturer specifications. IQ should include:

• Installation checks: Location, orientation, leveling, anchoring (if required), vibration dampening arrangements
• Utilities: Power supply compatibility (voltage, frequency, earthing), compressed air quality and pressure, vacuum connection integrity, water (if needed)
• Instrumentation: Sensors, gauges, and transmitters are installed correctly with serial number traceability
• Calibration: Verification that all measurement equipment is within calibration. Documentation to be attached for each instrument (e.g., pressure, flow, temperature sensors inside control panels or the compression chamber)
• Labels and signage: GMP-compliant labeling of instruments, control switches, access panels, and safety zones
• As-built dossier: Verification that all “as-built” drawings and manuals are updated to reflect site installation, including red-lined modifications
• Safety checks: Confirmation of operational safety interlocks, integrity of guards, clear emergency exit paths, fire extinguisher proximity, and absence of electrical hazards

Any non-compliance at this stage must be documented in the IQ deviation log, with impact assessment and required corrective actions.

Environmental and Utility Dependencies

The performance and compliance of a single rotary tablet press are directly linked to the quality of its environment and connected utilities. Key dependencies and their suggested acceptance criteria include:

• HVAC/Room Class: Equipment must be installed in an area that meets ISO 8 or equivalent (Class D) environmental classification. Particle count, temperature (typically 18–27°C), and relative humidity (30–60%) should be regularly monitored and logged.
• Compressed Air: Oil-free, dry, and filtered (minimum 0.01 μm filtration) air supplied at required pressure (commonly 6 bar ±0.5 bar). Air quality should meet ISO 8573-1:2010 [class 1.2.1 or better]
• RO/PUW Connections: Where cleaning-in-place (CIP) is envisaged, connection to purified or reverse osmosis water must be confirmed at specified flow rates and quality (conductivity, TOC)
• Steam (if present): Clean or culinary steam quality, at correct pressure, with condensate drainage
• Electrical Power Quality: Stable 3-phase or single-phase supply as required, spike/surge protection present; earthing resistance below 1Ω; dedicated MCB, RCD in control panel; phase sequence and voltage checks must be completed and documented
• Vacuum: Operational vacuum pump/system with validated filter change and condensate management procedures

These utility and environmental checks should be formally reviewed as part of site readiness prior to installation.

Traceability Table: URS Requirement to Test and Acceptance Criteria

Checklist for Supplier Document Package and DQ/IQ

Equipment-Specific Procedures and Acceptance Criteria

Additional qualification considerations unique to single rotary tablet presses include:

• Turret Alignment and Punch/Dies Fitting: Use gauge blocks and feeler gauges to check concentricity and run-out, complete test logbook entries; acceptance: deviation ≤ 0.03 mm.
• Lubrication System Check: Simulate lubrication cycle, inspect each distribution point for functional delivery; acceptance: all points deliver lubricant within 5 seconds of cycle start.
• Operator HMI Functionality: Test all modes (manual, semi-auto, auto), review access levels for user roles, simulate warnings/alarms; acceptance: operational modes selectable, unauthorized access locked, alarms visible/audible.
• Machine Cleanability: Dismantle, inspect accessibility, conduct swab tests post-CIP/SIP (if applicable); acceptance: contact surfaces cleanable to <10 ppm carryover, swab results documented.
• Product Flow and Recovery: Simulate material flow (using placebo) through feed hopper to dies, measure residual mass remaining, check powder recovery system (if present); acceptance: residual < 1% of batch mass, recovery system effective (≥98%).
• Noise and Vibration Monitoring: Operate at max speed, record db(A) at 1 m; acceptance: noise ≤ 85 db(A), vibration on mounts within manufacturer spec.
• Emergency Shutdown Test: Simulate power failure/emergency stop, verify safe shutdown and no risk of mechanical damage; acceptance: immediate halt, no unguarded movement.

Each of these procedures must be supported by detailed protocols, executed by qualified personnel, and rigorously documented to ensure traceability, reproducibility, and compliance.

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

Operational Qualification (OQ) of Single Rotary Tablet Press: Methodology and Controls

The Operational Qualification (OQ) phase is a critical step in the validation lifecycle of equipment used in Good Manufacturing Practice (GMP) environments. For a single rotary tablet press, OQ confirms that the machine and its subsystems operate within defined limits throughout the intended operating ranges. To ensure robust single rotary tablet press PQ (Performance Qualification), OQ must be thoroughly executed, capturing both mechanical and computerized system controls.

Functional Testing and Operating Ranges

OQ begins with rigorous functional testing of the single rotary tablet press. All major assemblies—such as the turret, feeding system, compression stations, and ejection mechanisms—are challenged under both minimum and maximum operating parameters. The goal is to verify correct response to setpoints and commands, including both manual and automated mode operation, if applicable.

• Operating Speed Test: The press is operated at its lowest, midpoint, and highest RPMs (e.g., 10, 35, and 70 RPM, respectively) to assure consistent motion, correct dwell times, and stable tablet formation. Example criterion: Tablet weight variation ≤ 2% at all speeds.
• Compression Force Range Test: Lower and upper compression forces (e.g., 10 kN and 50 kN) are applied to verify actuator and load cell responses, and to confirm the force display meters accurate readings at each setpoint.
• Feeder Consistency: Powder feeding is validated at both minimal and maximal fill-rates, ensuring uniform die fill and absence of bridging or material segregation.

Verification of Alarms and Interlocks

Proper functionality of machine alarms and interlocks must be established during OQ. Interlocks preventing start-up with open guards, misaligned tooling, or missing feeders are tested. Typical alarm conditions—such as door opening, overload, hopper empty, and abnormal compression force—are triggered intentionally to evaluate both visual and audible alarm responses and safe-system shutdown.

• Guard Interlock Test: The tablet press must halt when safety guards are opened, and an alarm should activate. Sample acceptance: System stops within one second of guard opening; warning light and buzzer engage.
• Overload Protection: Applying force above upper threshold should trip the overload circuit and prevent further operation until reset.
• Emergency Stop: All E-stop buttons are verified to ensure immediate system cut-off and no reset without supervisor intervention.

Setpoint Verification and Challenge Testing

Each critical setpoint—turret speed, pre-compression and main compression force, feeder rate, and tablet thickness—is programmably set, then measured and observed for stability and accuracy. Challenge tests include repeated toggling between setpoints and abrupt changes, confirming that PID controllers and feedback systems manage these transitions smoothly.

• Setpoint Holding: At 35 RPM and 30 kN target compression, achieved production must sustain ±2% of setpoints over 30-min continuous run (example).
• Auto-stop on Deviations: Simulate abnormal readings (e.g., simulate sensor failure) to ensure the machine enters safe mode and records alarm event.

Instrumentation Checks and Calibration Verification

Integrated sensors—such as compression force load cells, turret speed encoders, tablet thickness gauges, and weight control devices—must be verified for calibration status. Calibrated master instruments traceable to recognized standards are used for cross-verification.

• Compression Force Sensor: Using a calibrated dead weight tester, measured readings should be within ±1% of applied reference value.
• Turret RPM Sensor: Tachometer readings compared to the panel display should match within ±1 RPM across the operating range.
• Tablet Thickness Gauge: Calibration and linearity are checked using certified gauge blocks.

Calibration certificates of all critical instrumentation must be verified as current before initiating OQ.

OQ for Computerized Systems and Data Integrity

Single rotary tablet presses equipped with Human Machine Interface (HMI) or SCADA-based controls require additional OQ efforts to confirm GMP-compliant data handling. The following data integrity checks are essential:

• User Role Verification: Access controls are challenged so only authorized users (e.g., Operator, Supervisor, QC, Engineering) can perform specific actions such as start/stop, parameter changes, and alarm reset.
• Audit Trail Functionality: The system must record all critical GMP actions—setpoint adjustments, alarm acknowledgements, batch changeover—with time stamping and user identification. The audit trail should be uneditable by standard users.
• Time Synchronization: Device clock is checked against an external standard (e.g., NTP server or master plant clock) to within ±1 minute.
• Backup and Restore Testing: Batch recipe data and event logs are backed up, deleted, and restored to ensure retrieval reliability and integrity.

GMP Controls and Documentation Requirements

OQ execution is closely integrated with GMP procedures for handling material, equipment, and records. Line clearance—confirming area and equipment are free from previous product and residues—is performed before OQ runs. Status labeling (e.g., “Under OQ”, “Do Not Use”) and proper documentation (equipment logbooks, maintenance records) are strictly maintained.

• Status Labeling: The tablet press is prominently tagged with status during OQ execution, preventing unauthorized use.
• Logbooks: Utilization and maintenance logbooks are filled in real time, recording every activity and deviation throughout OQ. Entries are made in ink, signed, and dated according to GMP.
• Batch Record Integration: Simulated batch documentation is used to demonstrate the machine’s capability to integrate with manufacturing records, ensuring traceability and reconciliation.

Safety and Compliance Feature Verification

EHS (Environment, Health, Safety) controls are reviewed to confirm that the single rotary tablet press does not pose undue risk to operators or the facility.

• Safety Guards and Interlocks: All moving parts (turret, compression rollers) must be shielded, and guards equipped with tamper-proof interlocks.
• Pressure Relief: Dust extraction points and pressure relief devices are validated to operate per manufacturer specs.
• Emergency Stop Functionality: All E-stop switches on the press and local operator panels are tested for immediate power isolation.

OQ and Data Integrity Checklist for Single Rotary Tablet Press

By rigorously pursuing these OQ activities for single rotary tablet press PQ, pharmaceutical manufacturers assure not only equipment performance but also the integrity, traceability, and safety of the processes carried out on such critical production assets.

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

Performance Qualification (PQ) for Single Rotary Tablet Presses

The performance qualification (PQ) stage for a single rotary tablet press determines whether the press can reliably and consistently produce tablets that meet predefined quality criteria under routine and challenge conditions. Thorough PQ ensures the equipment meets operational expectations in actual GMP manufacturing scenarios for oral solid dosage forms, supporting product quality and patient safety.

PQ Strategies: Routine and Worst-Case

PQ is executed through a series of runs under normal operating conditions (routine) and anticipated worst-case scenarios. For a single rotary tablet press, worst-case considers factors such as:

• Maximum and minimum fill weight settings
• Maximum turret speed
• Most complex product and tooling setup
• Lowest and highest compression forces
• Longest run duration
• Use of edge-case tablets (largest/smallest, high/low potency)

PQ runs include both standard and challenge batches, establishing the robustness of the press control systems, tablet quality, and process repeatability.

Sampling Plans

Sampling during PQ must be statistically justified and span all critical process steps, including start-up, steady-state, and end-of-batch. For a single rotary tablet press, sample points should include:

• Initial 10–20 tablets (to monitor start-up variance)
• Periodic samples at regular intervals (e.g., every 30 minutes or X,000 tablets)
• End-of-batch samples (to confirm final product quality)
• Samples from known positions on the turret (e.g., first, middle, last punch stations)

Repeatability and Reproducibility

Demonstrating repeatability involves executing at least three consecutive batches at identical setpoints, confirming consistent performance (e.g., weight, hardness, output, quality). Reproducibility may include using different operators, shifts, materials, or tooling, to show that result consistency is maintained irrespective of these variables.

Acceptance Criteria in PQ

• All measured physical parameters (weight, hardness, friability, dimensions, content uniformity) meet approved specifications across all sampled locations and times
• No significant trends or out-of-specification (OOS) results across PQ batches
• Operational alarms, rejection systems, and safety functions perform as designed
• No evidence of unusual wear, sticking, or uncontrolled machine downtime
• Yield and output meet process expectations

Cleaning Validation and Cross-Contamination Controls

As a product-contact machine, the single rotary tablet press must be subjected to validated cleaning procedures to ensure no cross-contamination. PQ either directly includes or is closely linked to cleaning validation by:

• Verifying the machine can be effectively cleaned at required frequencies
• Ensuring that sampling after cleaning (swab/rinse) meets residue and carryover limits
• Challenging worst-case products (highest potency, most difficult-to-clean excipients)
• Confirming cleaning process repeatability and reproducibility

PQ summary reports should reference cleaning verification results, ensuring integration with overall equipment and area contamination control programs.

Continued Process Verification and Ongoing Qualification

Qualification does not end with initial PQ. Continued process verification (CPV) or continued qualification mandates that the single rotary tablet press’s critical parameters remain within validated ranges through routine operation. This is achieved by:

• Regular trending of process data (e.g., weight, hardness, downtime patterns) via Statistical Process Control (SPC)
• Periodic review of batch records
• Annual qualification/biannual maintenance qualification tests
• Triggering requalification if parameters trend out of specification, significant mechanical changes, or process deviations occur

SOPs, Training, Preventive Maintenance, Calibration, and Spares

• Standard Operating Procedures (SOPs): Well-defined SOPs for operation, cleaning, setup, breakdown, and emergency situations are mandatory.
• Training: Operators and technicians must be trained and qualified on both SOPs and the specific press model.
• Preventive Maintenance: Scheduled inspections, lubrication, parts replacement, and function checks are to be performed per manufacturer and GMP requirements.
• Calibration Program: Instruments (e.g., pressure gauges, speed sensors) must be on an approved calibration schedule; calibration status must be documented.
• Spares: An inventory of critical spare parts (e.g., punches, dies, motors) should be maintained to minimize downtime and ensure PQ continuity.

Change Control, Deviations, CAPA, and Requalification Triggers

A robust change control system must be implemented around the single rotary tablet press. Typical triggers for change management and potential requalification include:

• Major repairs or part replacements (e.g., new turret, replacement of control system components)
• Process parameter changes (e.g., new speed, new compression settings exceeding validation window)
• Introduction of new products/formulations
• Recurring deviations or out-of-trend PQ outcomes
• Upgrades to machine software or firmware

All deviations encountered during PQ or routine runs must be recorded and investigated per the site’s deviation management process. If required, Corrective and Preventive Actions (CAPA) are implemented, with effectiveness checks tied to PQ or requalification outcomes.

Validation Deliverables: Protocol and Report Structure

PQ protocols must be detailed, pre-approved documents outlining the scope, objective, test methods, selection of batches, sampling plans, acceptance criteria, responsible personnel, deviation handling procedures, and reference to all supporting documentation (e.g., SOPs, cleaning validation, maintenance records).

Key sections of a PQ protocol/report include:

• Scope and objectives
• Equipment and tooling details (including serial numbers, calibration status)
• List of critical process parameters to monitor
• Stepwise description of each test and sampling point
• Data collection templates and checklists
• Deviation and change management instructions
• Summary analysis and conclusion
• Summary of product-contact cleaning verification
• Comprehensive traceability matrix mapping each requirement to test results and objective evidence

The PQ summary report wraps up compliance or identifies gaps, includes all raw data in appendices, and provides final recommendations, linking to change control, CAPA, and requalification criteria.

Frequently Asked Questions (FAQ): Single Rotary Tablet Press PQ

How many batches are generally required for demonstrating PQ?

Usually, three consecutive batches are required for PQ, but specific requirements may vary based on risk assessment and regulatory expectations.

What’s the difference between PQ and routine in-process controls?

PQ is a formal, protocol-driven validation of equipment performance under predefined scenarios, while in-process controls are ongoing, batch-level checks during routine manufacturing.

How is cleaning validation integrated with PQ?

PQ references cleaning validation outcomes to confirm the press can be effectively cleaned after use, with sample analysis demonstrating removal of product residues and prevention of cross-contamination.

Can PQ be skipped if there is extensive vendor data?

No. Vendor data may support qualification but cannot substitute for site-specific, product-relevant PQ under actual use conditions within the manufacturing facility.

What should I do if a PQ test fails?

A documented deviation must be raised, investigated, and resolved with corrective/preventive actions. Depending on findings, partial or full PQ repetition and possible requalification may be required.

When is requalification of the single rotary tablet press necessary?

Triggers include major repairs, process changes beyond validated ranges, repeated deviations, or after a prolonged shutdown. Change control mechanisms dictate the specific actions required.

How often is ongoing qualification or CPV required?

CPV activities are typically continuous, with periodic formal reviews (annually or upon significant process/product changes) to confirm validated state.

Which documentation should be maintained for GMP compliance?

Full records of protocols, executed test results, validation reports, calibration and maintenance logs, deviation/CAPA records, and approved SOPs; all must be readily retrievable for regulatory inspection.

Conclusion

Performance Qualification of a single rotary tablet press represents a critical milestone in GMP equipment lifecycle management for oral solid dosage manufacturing. Rigorous and well-documented PQ confirms that the tablet press, under both routine and worst-case operating conditions, consistently meets product quality and regulatory requirements. Linking PQ with cleaning validation, robust SOPs, trained personnel, calibrated instrumentation, change control, and an ongoing process verification program ensures that the validated state is both achieved and maintained over time. Properly executed and supported by comprehensive validation deliverables, single rotary tablet press PQ provides strong assurance of equipment reliability, product integrity, and regulatory compliance—protecting both the patient and the manufacturer.