Qualification of manufacturing equipment & analytical instruments

M. Pharm. Pharmaceutical Quality Assurance
Subject:- Pharmaceutical Validation
Presented By :- Mohd Sameer
Presented To :- Dr. Yasmin Sultana
Qualification of manufacturing
equipment & analytical instruments:

Introduction
Equipment Qualification:
Equipment is a collective analytical measurement assembled to perform a mechanical process.
▶
Without an equipment, we cannot manufacture a product.
▶
So, EQ (Equipment Qualification) is an action of proving that an equipment works correctly and
▶
accordingly so, as to give the accurate and reliable result.
If equipment is validated, we can ensure that our product is of best quality.
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So, term validation and qualification are interlinked to each other.
▶
QUALIFICATION:
Qualification is a process of proving and documenting that an equipment or its ancillary system is
installed properly, works accordingly, and leads to the actual expected result.
So, term QUALIFICATION is categorized into four different parts as follows:
I. Design Qualification
II. Installation Qualification
III. Operational Qualification
IV. Performance Qualification

WHY IT IS REQUIRED?
▶ To increased throughput
For reduction in rejections and reworking
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For reduction in utility costs
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For avoidance of capital expenditures
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Fewer complaints about process-related failures
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Reduced testing in-process and in finished goods
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More rapid and reliable start-up of new equipment
▶
Easier scale-up from development work
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Easier maintenance of equipment
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Improved employee awareness of processes
▶
More rapid automation
▶

Who should do Equipment Validation?
▶ The vendor or the user has the ultimate responsibility for the accuracy of
the analysis results and also for equipment qualification.
▶ DQ should always be done by the user.
▶ While IQ for a small and low-cost instrument is usually done by the user,
IQ for large, complex, and high-cost instruments should be done by the
vendor.
▶ OQ can be done by either the user or the vendor.
▶ PQ should always be done by the user because it is very application-
specific, and the vendor may not be familiar with these.
▶ As PQ should be done on a daily basis, this practically limits this task to
the user.

Design Qualification (DQ):
▶ "Design qualification (DQ) defines the functional and operational
specifications of the instrument and details for the conscious decisions in
the selection of the supplier."
▶ The steps that should be considered for inclusion in a design
qualification:
•Description of the analysis problem
•Description of the intended use of the equipment
•Description of the intended environment
•Preliminary selection of the functional and performance specifications
•Preliminary selection of the supplier
•Final selection of the equipment
•Final selection of the supplier
•Development and documentation of final functional and operational
specifications

Installation Qualification (IQ):
▶ "Installation qualification establishes that the instrument is
received as designed and specified, that it is properly installed in the
selected environment, and that this environment is suitable for the
operation and use of the instrument."
The qualification involves the coordinated efforts of:
The vendor.
▶
The operating department.
▶
The project team (which provides input into the purchase,
▶
installation, operation, and maintenance of the equipment).

Operational Qualification (OQ):
▶ "Operational qualification (OQ) is the process of demonstrating that an
instrument will function according to its operational specification in the selected
environment."
▶ The proper operation of equipment is verified by performing the test functions
specified in the protocol.
▶ A conclusion is drawn regarding the operation of equipment after the test
functions are completed and all data has been analyzed.
Following are the contents of equipment operation qualification:
1.Application S.O.P’s
2.Utilization List
3.Process Description
4.Test Instrument Utilized To Conduct Test
5.Test Instrument Calibration
6.Critical Parameters
7.Test Function (List)
8.Test Function Summaries

Performance Qualification (PQ):
▶ "Performance Qualification (PQ) is the process of demonstrating
that an instrument consistently performs according to a specification
appropriate for its routine use."
▶ PQ should always be performed under conditions that are similar
to routine sample analysis.
▶ PQ should be performed on a daily basis or whenever the
equipment is being used.
▶ In practice, PQ can mean system suitability testing, where critical
key system performance characteristics are measured and compared
with documented specifications.

Types of Powder Blender:
•V cone Blender
•Double Cone Blender
•Drum mixture
•Ribbon Blender
•Conical Screw Mixer
•Tumble Blender
Qualification of Dry Powder Mixer:

I. Design Qualification (DQ)
✅ Ensures the mixer meets process, safety, and regulatory requirements.
✅ Key aspects: Equipment type, capacity, material of construction
(SS316/SS304), mixing efficiency, power supply, and safety features.
✅ Compliance with GMP, FDA 21 CFR Part 11, and ISO standards.
✅ Verification of supplier credentials, design specifications, and
documentation.
II. Installation Qualification (IQ)
✅ Confirms correct installation and assembly.
✅ Checklist: Equipment verification, utility connections, component
identification, and software/system checks.
✅ Safety validation: Emergency stop, interlocks, and compliance with
manufacturer’s guidelines.
✅ Documentation: Calibration certificates, manuals, and IQ report
approval.

III. Operational Qualification (OQ)
✅ Verifies mixer functionality under controlled conditions.
✅ Tests include: Speed validation, mixing time efficiency, interlock
checks, load testing, and cleaning validation.
✅ Ensures blending uniformity and proper operation of discharge
mechanisms.
✅ Documentation: OQ test reports, calibration records, and QA
approval.
IV. Performance Qualification (PQ)
✅ Confirms consistent performance in routine production.
✅ Tests: Mixing uniformity, batch reproducibility, capacity validation,
and environmental impact assessment.
✅ Cleaning validation: Swab tests to prevent cross-contamination.
✅ Documentation: PQ reports, batch records, and validation team
approval.

Qualification of Fluid Bed Dryer:

✅ Ensures the FBD design meets process, safety, and regulatory requirements.
✅ Key aspects: Capacity (kg/batch), material of construction (SS316/SS304), air
handling system, filters, inlet/outlet temperature range, and control systems.
✅ Verification of supplier credentials, design specifications, and documentation.
✅ Confirms correct installation as per manufacturer’s specifications.
✅ Checklist: Equipment identification, utility verification (compressed air,
electrical supply, exhaust system), filter installation, and airflow validation.
✅ Safety validation: Emergency stop, interlocks, explosion protection, and
grounding verification.
✅ Documentation: Calibration certificates, user manuals, and IQ report
approval.

✅ Verifies FBD functionality under controlled conditions.
✅ Tests include:
•Blower speed and airflow validation
•Heating system efficiency (inlet/outlet temperature checks)
•Filter integrity testing
•Drying cycle time and uniformity tests
•PLC/SCADA system validation (if applicable)
✅ Documentation: OQ test reports, calibration records, and QA approval.
✅ Confirms consistent drying performance in routine production.
✅ Tests:
•Moisture content uniformity in dried product
•Batch reproducibility with different loads
•Cleaning validation (swab test for cross-contamination)
•Energy consumption efficiency
✅ Documentation: PQ reports, batch records, and validation team approval.

✅ Ensures the tray dryer design meets process, safety, and regulatory requirements.
✅ Key aspects: Capacity (number of trays), material of construction
(SS316/SS304), air circulation system, heating elements, temperature range, and
control panel.
✅ Verification of supplier credentials, design specifications, and documentation.
✅ Checklist:
•Equipment identification and verification
•Utility connections (power supply, exhaust system, airflow direction, and
ducting)
•Tray alignment and positioning
•Temperature control panel and safety interlocks
✅ Documentation: Calibration certificates, user manuals, and IQ report approval.

✅ Verifies tray dryer functionality under controlled conditions.
✅ Tests include:
•Blower speed and air circulation efficiency
•Heating system uniformity (temperature mapping across trays)
•Safety checks (overheating protection, emergency shutdown, alarms, and
interlocks)
•Tray positioning and heat distribution validation
✅ Documentation: OQ test reports, calibration records, and QA approval.
✅ Confirms consistent drying performance in routine production.
✅ Tests:
•Moisture content uniformity across trays
•Batch reproducibility with different loads
•Cleaning validation (swab test for residue and cross-contamination)
•Energy efficiency and operational stability

Qualification of Tablet Compression
Machine :

✅ Ensures that the tablet compression machine design meets process, safety, and regulatory
standards.
✅ Key aspects:
•Machine capacity (compression force, tablet output per hour)
•Material of construction (SS316 for contact parts)
•Type of tooling (B, D, BB, DB punch sets)
•Pre-compression and main compression force settings
•Control system (HMI, automation, data integrity compliance - 21 CFR Part 11)
✅ Compliance with GMP, WHO, FDA, and ISO standards.
✅ Checklist:
•Power supply, lubrication system, air supply, and dust extraction setup
•Die and punch alignment with turret
•Control panel installation and emergency stop testing
✅ Documentation: Calibration certificates, manuals, and IQ report approval.

✅ Verifies machine functionality under controlled conditions.
✅ Tests include:
•Compression force uniformity
•Tablet weight, thickness, and hardness variation testing
•Punch and die movement synchronization
•Ejection system and rejection of defective tablets
•Speed control and noise level verification
✅ Documentation: OQ reports, calibration records, and QA approval.
✅ Confirms consistent performance during actual tablet production.
✅ Tests:
•Batch-to-batch weight uniformity and hardness consistency
•Dissolution and disintegration time validation
•Rejection system efficiency (detecting defective tablets)
•Cleaning validation (residue analysis and cross-contamination check)
✅ Documentation: PQ reports, batch records, and validation approval.

Qualification of Dry Heat
Sterilization / Tunnels :

✅ Ensures the sterilizer/tunnel design meets process, safety, and regulatory standards.
✅ Key aspects:
•Temperature range (160°C – 250°C) for sterilization & depyrogenation
•Airflow pattern (laminar flow for uniform heat distribution)
•Material of construction (SS316 for product-contact parts)
•HEPA filter efficiency (99.97% for particle removal)
•Belt speed & dwell time for depyrogenation validation
•Compliance with GMP, FDA, ISO 13485, and 21 CFR Part 11.
✅ Verifies proper installation as per manufacturer’s specifications.
✅ Checklist:
•Equipment verification (chamber, filters, temperature sensors, conveyors)
•Utility connections (electrical supply, compressed air, exhaust system)
•Thermocouple placement & calibration of temperature sensors
•Filter integrity testing (DOP/PAO test for HEPA filters)
✅ Documentation: IQ report, calibration certificates, manuals, and approval.

✅ Ensures proper functioning under controlled conditions.
✅ Tests include:
•Heat distribution uniformity (empty chamber)
•Dwell time validation at set temperatures (≥ 30 min at 250°C for depyrogenation)
•Cold spots identification using thermocouples
•HEPA filter air velocity measurement & leak test
•Safety interlocks & alarm system verification
✅ Documentation: OQ reports, thermal mapping, and QA approval.
✅ Confirms consistent sterilization/depyrogenation performance during actual use.
✅ Tests:
•Sterility assurance (Biological Indicator validation with Bacillus atrophaeus spores
for dry heat sterilization)
•Endotoxin reduction test (≥ 3-log reduction using LAL test for depyrogenation)
•Thermal validation with load (glassware, vials, stoppers)
•Particulate count monitoring (before & after sterilization)

✅ Ensures that the autoclave design meets process, safety, and regulatory
requirements.
✅ Key aspects:
•Sterilization method: Saturated steam (121°C–134°C, 15–30 psi)
•Chamber material: SS316L (corrosion-resistant)
•Temperature & pressure sensors calibration
•Drainage system for condensate removal
•Compliance with GMP, FDA, ISO 17665, and 21 CFR Part 11
✅ Confirms proper installation as per manufacturer’s specifications.
✅ Checklist:
•Verification of chamber, gaskets, steam source, piping, and control panel
•Utility connections (water supply, drain, electricity, and compressed air)
•Calibration of pressure gauges, temperature probes, and cycle timers
•Safety features check (pressure release valves, alarms, door interlocks)
✅ Documentation: IQ report, calibration certificates, manuals, and approvals.

✅ Ensures proper functioning under controlled conditions.
✅ Tests include:
•Heat distribution study (empty chamber mapping)
•Bowie-Dick test for steam penetration (for vacuum autoclaves)
•Leak test (vacuum integrity check)
•Cycle performance at different loads (e.g., porous loads, liquids, instruments)
•Sensor calibration verification
✅ Documentation: OQ reports, thermal mapping, and QA approval.
✅ Confirms consistent sterilization performance during routine operation.
✅ Tests:
•Biological Indicator (BI) validation (Geobacillus stearothermophilus spores at
121°C)
•Chemical indicator verification (autoclave tapes, integrators)
•Load pattern validation (worst-case load scenario testing)
•Moisture check for sterilized loads (to prevent wet packs)
•Cycle reproducibility (3 consecutive successful runs)

Qualification of Membrane
Filtration :

✅ Ensures the membrane filtration system meets required specifications for sterility
assurance.
✅ Key considerations:
•Membrane material (PVDF, PES, Nylon, PTFE)
•Pore size (typically 0.22 µm for sterile filtration)
•Compatibility with process fluids
•Flow rate, pressure, and temperature limits
•Compliance with regulatory standards (USP <1227>, FDA, EU GMP, ISO 13408-2)
✅ Confirms proper installation as per manufacturer’s guidelines.
✅ Checklist:
•Filter housing installation and integrity
•Utility connections (compressed air, water, steam-in-place compatibility)
•Sealing and gasket verification
•Pressure gauge, flow meter, and sensor calibration
✅ Documentation: IQ report, SOPs, calibration records, supplier certificates.

✅ Ensures proper functioning under standard conditions.
✅ Tests include:
•Bubble point test (integrity check of membrane filters)
•Diffusion test (membrane integrity verification)
•Pressure hold test (detects leaks in the system)
•Filtration efficiency test (removal of microbial and particulate contaminants)
✅ Documentation: OQ reports, validation protocols, test records.
✅ Confirms consistent performance during routine operation.
✅ Tests:
•Filter validation using microbial challenge test (Brevundimonas diminuta for
0.22 µm filters)
•Flow rate consistency across multiple filtration cycles
•Sterility assurance and endotoxin removal validation
•Filter life cycle and reusability assessment
✅ Documentation: PQ reports, batch records, and quality assurance approvals.

Qualification of Capsule Filling
Machine :

✅ Ensures the capsule filling machine meets process, safety, and regulatory
requirements.
•Capsule size compatibility (e.g., Size 000 to 5)
•Filling type (powder, granules, pellets, liquids, tablets-in-capsule)
•Material of construction (SS316 for product contact parts)
•Filling accuracy and speed (capsules per minute)
•Vacuum system for capsule separation
•Control system compliance (21 CFR Part 11 for electronic records)
•Compliance with GMP, FDA, ISO, and WHO guidelines
✅ Verifies correct installation as per manufacturer’s specifications.
✅ Checklist:
•Power supply, compressed air, and vacuum system setup
•Alignment of capsule loading, filling, and sealing stations
•Safety interlocks and emergency stop functionality
✅ Documentation: IQ report, calibration certificates, manuals, and approvals.

✅ Ensures proper functionality under controlled conditions.
✅ Tests include:
•Capsule separation efficiency
•Filling weight variation test (±5% of target weight)
•Machine speed adjustment and performance validation
•Dust collection and vacuum system efficiency
•Reject system functionality for defective capsules
✅ Documentation: OQ reports, validation records, and QA approval.
✅ Confirms consistent performance during routine production.
✅ Tests:
•Weight uniformity of filled capsules
•Capsule locking integrity (sealing effectiveness test)
•Batch-to-batch reproducibility check
•Cleaning validation (swab test for residue detection)
•Yield calculation (acceptable rejection rate within limits)

Qualification of UV-Visible
Spectrophotometer :

✅ Ensures the UV-Visible spectrophotometer meets analytical and regulatory
requirements.
•Wavelength range (typically 190–1100 nm)
•Light source (Deuterium & Tungsten-Halogen lamps)
•Optical system (single or double beam)
•Detector type (Photodiode array, PMT, or Silicon detector)
•Software compliance with 21 CFR Part 11 for data integrity
•Compliance with USP, Ph. Eur., ICH Q2(R1), and ISO 17025
✅ Checklist:
•Verification of instrument components (cuvette holder, lamps, detector, control unit)
•Proper electrical connections and environmental conditions (temperature, humidity,
vibration-free surface)
•Software installation and user access control setup
•Calibration of wavelength and absorbance scale
✅ Documentation: IQ report, SOPs, user manuals, and calibration certificates.

✅ Tests include:
•Wavelength accuracy check using Holmium oxide filter (Certified Standard Reference
Material, SRM)
•Photometric accuracy using potassium dichromate solution (±0.005 Abs deviation at specified
wavelengths)
•Baseline stability test (Absorbance drift over a defined time period)
•Stray light test using potassium chloride (for UV region) and sodium nitrite (for visible region)
•Resolution test using Toluene in hexane (ratio of peak absorbance at 269 nm & 266 nm ≥1.5)
✅ Documentation: OQ reports, calibration logs, and QA approval.
✅ Confirms consistent performance during routine use.
✅ Tests:
•Precision & repeatability check using standard solutions (multiple scans and RSD ≤1.0%)
•Linearity test (Absorbance vs. concentration plot, R² ≥ 0.999)
•System suitability test with known reference standards
•Reproducibility and inter-day variation study
•Cleaning validation (residue check on cuvettes & optical surfaces)

Qualification of FTIR (Fourier
Transform Infrared)
Spectrophotometer :

✅ Ensures the FTIR spectrophotometer meets analytical and regulatory requirements.
•Wavelength range (typically 4000–400 cm ¹)
⁻
•Detector type (DTGS, MCT, or Photoconductive detector)
•Beam splitter material (KBr, ZnSe, or CaF )
₂
•Interferometer type (Michelson interferometer with laser reference)
•Sampling accessories (ATR, transmission, or diffuse reflectance modes)
•Compliance with USP <854>, Ph. Eur., ICH Q2(R1), and ISO 17025
✅ Checklist:
•Verification of instrument components (interferometer, light source, sample holder,
detector)
•Proper electrical connections and environmental conditions (temperature, humidity,
vibration-free surface)
•Calibration of wavelength and interferometer alignment

✅ Tests include:
•Wavelength accuracy using polystyrene film (Certified Standard Reference Material,
SRM, with peaks at 1601 cm ¹, 3060 cm ¹, etc.)
⁻ ⁻
•Resolution test using polystyrene film (ratio of 2870 cm ¹/2849 cm ¹ ≥ 1.3)
⁻ ⁻
•Signal-to-noise ratio (baseline stability and sensitivity check)
•Repeatability test (multiple scans of the same sample with consistent results)
✅ Tests:
•Precision & repeatability check using standard materials (e.g., polystyrene film, USP
reference standards)
•Linearity test using known concentration standards (R² ≥ 0.999)
•Reproducibility test with inter-day variation study
•System suitability test with reference spectra comparison
•Cleaning validation (checking ATR crystal or sample holder for contamination)

Qualification of DSC (Differential
Scanning Calorimeter) :

✅ Ensures the DSC system meets analytical and regulatory requirements.
•Temperature range (e.g., -180°C to 750°C depending on the model)
•Heating and cooling rate control (e.g., 0.1–100°C/min)
•Sensor type (heat flux or power compensation DSC)
•Atmosphere control (nitrogen, oxygen, or inert gases)
•Compliance with USP <891>, Ph. Eur., ICH Q2(R1), and ISO 11357-1
✅ Checklist:
•Verification of instrument components (sample holder, furnace, cooling system, purge
gas setup)
•Electrical connections and system calibration check
•Verification of thermocouples and heat flow sensors

✅ Tests include:
•Temperature accuracy check using Indium, Zinc, and Tin standards (Melting point
verification)
•Heat flow calibration using Sapphire standard
•Baseline stability test (measuring a blank run at different heating rates)
•Reproducibility test (multiple scans of the same material with consistent results)
✅ Tests:
•Precision & repeatability check using reference materials (e.g., indium, lead,
aluminum)
•Glass transition temperature (Tg) verification for polymers
•System suitability test with known standard samples
•Reproducibility and inter-day variation study
•Cleaning validation (checking sample pans and furnace for contamination)

Qualification of Gas Chromatography
(GC) :

✅ Ensures the GC system meets analytical and regulatory requirements.
•Injector type (Split/Splitless, PTV, Headspace, etc.)
•Column type (Capillary, Packed, stationary phase selection)
•Detector type (FID, TCD, ECD, MS, etc.)
•Carrier gas compatibility (Helium, Hydrogen, Nitrogen, Argon)
•Flow control (Electronic Pneumatic Control - EPC)
•Temperature control for the injector, column oven, and detector
✅ Checklist:
•Verification of instrument components (injector, column, detector, gas supply, autosampler,
data system)
•Electrical connections and pressure regulator installation
•Carrier gas purity check and leak test

✅ Tests include:
•Injector precision test (repeatability of injections, RSD ≤ 2%)
•Column oven temperature accuracy verification (±1°C deviation allowed)
•Flow rate accuracy check using soap bubble flowmeter or EPC validation
•Retention time reproducibility (RSD ≤ 1.0%)
•Detector response test using known concentration standard solutions
•Baseline stability test (noise level and drift measurement)
✅ Tests:
•Precision & repeatability check using a standard reference mixture
•Linearity test (Response vs. concentration plot, R² ≥ 0.999)
•Resolution test (Baseline separation of critical peaks)
•Carryover test (blank injection after a high-concentration sample)
•Reproducibility test (inter-day variation study with RSD ≤ 2%)
•Cleaning validation (residue check in the injection port, detector, and column)

Qualification of High-Performance
Liquid Chromatography (HPLC) :

✅ Ensures the HPLC system meets analytical and regulatory requirements.
•Pump type (Isocratic, Gradient, Quaternary, Binary)
•Injector system (Manual, Autosampler, Loop size compatibility)
•Column compatibility (C18, C8, Phenyl, Size, Particle size, Pore size)
•Detector type (UV-Vis, PDA, Fluorescence, Refractive Index, MS)
•Flow rate range (e.g., 0.01–10.0 mL/min)
•Column oven temperature control (±0.1°C precision)
✅ Checklist:
•Verification of instrument components (pump, injector, column oven, detector, data system,
autosampler)
•Mobile phase degassing system functionality check
•Leak test and system pressure validation

✅ Tests include:
•Flow rate accuracy test (±1% deviation from set value using a gravimetric method)
•Injection volume accuracy test (RSD ≤ 1% for multiple injections)
•Column oven temperature accuracy test (±0.5°C deviation allowed)
•Detector linearity test using standard solutions (R² ≥ 0.999)
•Wavelength accuracy test using Holmium oxide filter or Caffeine (UV-Vis at 273 & 205 nm)
•Baseline stability test (noise level and drift measurement)
✅ Tests:
•Precision & repeatability test (RSD ≤ 2% for six injections of a standard solution)
•System suitability test (resolution, peak symmetry, tailing factor, theoretical plates)
•Retention time reproducibility (RSD ≤ 1%)
•Carryover test (blank injection after a high-concentration sample)
•Gradient accuracy test (for gradient systems, ensuring composition accuracy)
•Cleaning validation (residue check in flow path, column, and detector cell)

Qualification of HPTLC (High-
Performance Thin Layer
Chromatography) :

✅ Ensures the HPTLC system meets analytical and regulatory requirements.
•Applicator type (Automated sample application system - spray-on, band, or spot
application)
•Plate type (Silica gel, C18, Alumina, etc.)
•Chamber type (Glass twin-trough, Horizontal, or Automated development chamber)
•Detector system (UV, Fluorescence, Densitometric, Mass detection)
✅ Checklist:
•Verification of system components (Applicator, Development Chamber, Scanner, Data
system)
•Environmental condition verification (temperature, humidity, vibration-free surface)
•UV lamp and fluorescence detector verification

✅ Tests include:
•Sample application accuracy (spot size, volume, and position accuracy verification)
•Development chamber uniformity test (solvent migration distance and time control)
•Scanner calibration (Wavelength accuracy using Holmium filter, linearity check with
reference standards, R² ≥ 0.999)
•Densitometric detector sensitivity test (signal-to-noise ratio and baseline stability)
•Reproducibility test (spot intensity and migration pattern should be consistent across runs)
✅ Tests:
•Precision & repeatability test using standard reference samples (RSD ≤ 2%)
•System suitability test (Rf value consistency, peak symmetry, resolution)
•Retention factor (Rf) reproducibility check (≤ ±5% deviation from standard Rf values)
•Carryover test (blank plate run after high-concentration sample)
•Cleaning validation (residue check on plates, scanner, and development chamber)

Qualification of LC-MS (Liquid
Chromatography-Mass
Spectrometry) :

✅ Ensures the LC-MS system meets analytical and regulatory requirements.
•HPLC system (Pump type: Isocratic, Binary, Quaternary)
•Injection system (Manual or Autosampler)
•Column compatibility (C18, C8, Phenyl, etc.)
•Ionization source (ESI, APCI, MALDI, etc.)
•Mass analyzer type (Quadrupole, TOF, Ion Trap, Orbitrap, Hybrid MS)
•Detector sensitivity and dynamic range
•Compliance with USP <621>, ICH Q2(R1), Ph. Eur., and ISO 17025
✅ Checklist:
•Verification of all components (HPLC, Ionization source, Mass analyzer, Data system)
•Electrical and gas connections (N2, Ar, He) verification
•Vacuum system and exhaust setup check
•Calibration gas verification

✅ Tests include:
•HPLC system validation (Flow rate accuracy, Injection precision, Column temperature control)
•Mass accuracy test using standard calibration compounds (±0.2 Da for low-res MS, ±5 ppm for
HRMS)
•Signal-to-noise ratio test (for sensitivity verification)
•Ionization efficiency and stability test
•Baseline stability and mass drift evaluation
•Peak resolution and reproducibility test
✅ Tests:
•Precision & repeatability test (RSD ≤ 2% for standard injections)
•System suitability test (Mass resolution, Peak symmetry, Retention time consistency)
•Mass spectral library matching test
•Dynamic range and linearity test (R² ≥ 0.999 for quantification standards)
•Carryover test (Blank injection after high-concentration sample)
•Cleaning validation (No residue in LC column, ionization source, and MS inlet)

Qualification of manufacturing equipment & analytical instruments

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