Laboratory Instrument Qualification Demonstrate ... 7... · Laboratory Instrument Qualification...

Laboratory InstrumentQualification

Demonstrate Suitability for use

Jerry Lanese

The Lanese Group, Inc.

IVTLaboratory Compliance Week

Why are you here?

Outline

Requirement for instrument qualification

The industry solution

Maintaining qualification

Interactive exercise

It is the goal of every analyst and every quality control laboratory to report data

that accurately reflect the measured parameters of the material under test.

It is:

–Good business

–Good science

That we provide assurance that each instrument performs as intended with appropriate uncertainty.

It is:

Also required by the regulations.

Where?

Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such equipment is so used, it shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections shall be maintained.

21CFR211.68

It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process.

Annex 15

Each laboratory should implement procedures that provide the highest level of assurance of the quality of

the data reported.

Components of Data Quality

Analytical Instrument Qualification

Analytical Method Validation

SystemSuitability Tests

QualityControl

Check Samples

USP <1058>

Components of Analytical Instrument Qualification

Design QualificationInstallation Qualification

Operational QualificationPerformance Qualification

Define your terms

The boundaries of qualifications activities are fuzzy.

Define your terms

Components of Instrument Qualification

Instrument Lifecycle

ICH Q10 Pharmaceutical Quality System

Pharmaceutical

Development

Technology

Transfer

Commercial

Manufacturing

Product

Discontinuance

GMPInvestigational

Products

Management Responsibilities

Knowledge Management

Quality Risk Management

Process Performance and Product Quality Monitoring System

Corrective Action/Preventive Action (CAPA) System

Change Management System

Management Review

Elements

Enablers

User RequirementsDesign Qualification

Installation QualificationOperational Qualification

Performance Qualification

Development Technology

Transfer

Commercial

Testing

Instrument

Discontinuance

Instrument Lifecycle

Stage 1

Process Design

Stage 2

Process

Qualification

Stage 3

Continued Process

Verification

Measuring Process Lifecycle

Identify and document intended use

Laboratory Instrument and Equipment Lifecycle

Intended use includes:

What material will be tested?

What other analytes will be present?

What stage of the product lifecycle.

Pharmaceutical

Development

Technology

Transfer

Commercial

Manufacturing

Product

Discontinuance

GMPInvestigational

Products

Management Review

Elements

Enablers

Intended use includes:

What material will be tested? What other analytes will be present? What stage of the product lifecycle. What stage of the production process? What attribute will be determined? What are the attribute specifications? What laboratory will be performing the test? What analysts will be performing the test?

– Education– Training– Experience

Identify intended use DQQualify vendor

Review Instrument capabilities

Specifications

Receive instrumentInstall IQ PQ

Laboratory Instrument and Equipment Lifecycle

Decommission

IQ OQ PQ

Continued use

Routine, periodic

Change Control

Move Instrument and original application

Change Intended

The 4Q Model

What should be included in the qualification?

Intended use

Risk analysis

IQ OQ PQ

Change Control

The establishment of any specifications, standards, sampling, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.

21CFR211.160(a)

Pharmaceutical

Development

Technology

Transfer

Commercial

Manufacturing

Product

Discontinuance

GMPInvestigational

Products

Management Review

Elements

Enablers

Master Plan

The organization should have a Master Plan for all validation activities. (VMP)

Site or laboratory

Includes instrument/equipment qualifications.

Provides general guidance on each step of the validation and qualification process.

Supported by specific activity SOPs

May include IQ, OQ and OQ templates.

Validation Master Plan

Determining intended use

Receiving new laboratory

instruments

Preparing Installation

Qualification Protocols

Archival of Qualification

Reports

Operational Qualification of Balances

Operational Qualification

of HPLCs

Handling Deviations to

Validation Protocols

Quality Review of Validation Protocols

and ReportsTrending of

Qualification of Laboratory Instruments and Equipment

Items that might be included in instrument/equipment qualification master plan

Scope of the plan (total site, laboratory)

Responsibilities

Reference to related plans and procedures

Equipment that is to be qualified

Overview to the approach to qualification

Requirement and guidance for risk assessment

The steps of instrument/equipment qualification

Evaluation (qualification) of vendors

Change control

Decommissioning of instruments

Templates

Design Qualification

The documented collection of activities that define the functional and operational specifications of the instrument and criteria for the selection of the vendors, based on the intended purpose of the instrument.

USP <1058>

DQ should include:

Design and produce instrument that meets defined requirements.

Determine intended use.

Identify vendors who operate under a robust quality system and produces an instrument that meets intended use

Select vendor

Qualify vendor

Record all observations. Use templates where possible

Design QualificationPerformed by

Developer (instrument manufacturer)Robust design

Based on functional requirements

Product specifications

Discussions

User (Organization installing the unit)Understand the test process and why it was selected.

Define intended use of instrument/equipment.

Determine functional requirements and specifications.

Design Qualification

VMP may include template for any or all of the information that should be collected.

Understand and document the intended use of the instrument.

• Type of test

• Location

• Monitored process

• Specifications

• Technical competence of users

Installation Qualification

The documented collection of activities necessary to establish that an instrument is delivered as designed and specified, and is properly installed in the selected environment, and that this environment is suitable for the instrument.

USP <1058>

IQ should include:

Assure that the laboratory utilities and facility meet vendor requirements.

If critical, assure that environmental conditions are controlled and recorded.

Assure that all items listed on purchase order have been received.

Determine that there has been no damage to the instrument/equipment during shipment.

Record all observations. Use templates where possible.

IQ should include:

Verify that the materials and construction are consistent with vendor specifications and user requirements.

Assure that all documents (operating manuals, maintenance and testing procedures, safety procedures, validation certificates) are present and complete.

Install hardware: fittings, tubing for fluid or gas flow, HPLC or GC columns, power cables, date or network cables, other cables.

IQ should include:

Switch instrument and modules on. Ensure that modules power up and software boots up.

Perform any self test routines.

List equipment manuals and pertinent SOPs

Record system and component model numbers and serial numbers.

Record firmware and software revisions.

IQ should include:

Enter instrument model number, serial number and other required instrument data into the instrument asset management database.

Prepare required installation report(s).

Prepare, review and sign IQ documentation.

IQ OQ PQ

Continued use

Routine, periodic

Change Control

Change Intended

Will IQ be repeated?

The documented collection of activities necessary to demonstrate that an instrument, or equipment, will function according to its operational specifications in the selected environment.

USP <1058>

Typical issues:

What should be tested?

What process should be used for the testing

What are the acceptance criteria?

Who should perform the testing?

USP guidance

Users, or their qualified designees, should perform appropriate tests to verify that the instrument meets manufacturer or user specifications in the user’s environment.

USP <1058>

What should be tested?

Parameters that will demonstrate that the instrument is consistently operating in a state of control in conformance with applicable specifications.

What process should be used for the testing?

All tests should be defined in the protocol.

Vendor protocol and testing may be used.

As much as possible rely on SOPs.

Where internal SOPs do not exist, tests should be described in detail in the protocol.

Any vendor protocol or test should have appropriate internal technical

review and quality approval.

What are the acceptance criteria?

Acceptance criteria should be based on the intended use of the equipment or instrument. They should be based on good science, risk and process uncertainties.

Who should perform the testing?

Testing may be performed by vendors, contractors or internal resources.

All individuals involved in the qualification process should be qualified with the appropriate education, training and/or experience.

Should be repeated routinely according to a program.

IQ OQ PQ

Continued use

Routine, periodic

Change Control

Change Intended

The 4Q Model

The documented collection of activities necessary to demonstrate that an instrument consistently performs according to the specifications defined by the user, and is appropriate for the intended use.

USP <1058>

Continued Process Verificationis a part of

Analytical Instrument Qualification

Analytical Method Validation

SystemSuitability Tests

QualityControl

Check Samples

Consistent

TrendSystem capability

Statistical evaluation

Pharmaceutical

Development

Technology

Transfer

Commercial

Manufacturing

Product

Discontinuance

GMPInvestigational

Products

Management Review

Elements

Enablers

Conditions should replicate routine testing process.

Performed whenever instrument is used.

Frequency dependent on:

Test criticality.

Instrument and system robustness.

Component dependability.

USP <1058>

The organization should develop a laboratory equipment and instrument qualification

program that covers the 4Qs.

Complete, in depth qualification of all laboratory equipment and

instruments requires extensive resources

Is there an efficient way to accomplish instrument qualification?

Industry recognition of the issue

Formation of an industry committee

Evaluation of the risk associated with equipment and instruments

Identification of risk groups

USP <1058>

Instrument/equipment Groups

The Laboratory Instrument/Equipment World

Group A

Standard equipment with no measurement capability, or requirement for calibration. The manufacturers specification of the functionality is accepted as user requirement.

Nitrogen evaporators

Magnetic stirrers

Vortex mixers

centrifuges

Group A

Conformance of equipment with user requirements may be verified and documented through visual observation of its operation.

Basic IQLimited OQ

Group A

Magnetic stirrer

Verify that specifications for the identified stirrer demonstrate that it will stir the target liquid at the desired rpms.

Verify that ordered item and accessories were delivered.

Verify that the stirrer will stir the target liquid.

Group B

Standard equipment and instruments that provide measured values. Also, equipment controlling physical parameters that need calibration where the user requirements are typically the same as the manufacturer’s specification of functionality and operational limits

Group B

Balances

Melting point apparatus

Microscopes (light)

pH meters

Variable pipets

Refractometers

Thermometers

Titrators

Viscometers

Muffle furnaces

Refrigerators

Freezers

Water baths

dilutors

Group B

Conformance of the instrument or equipment to user requirements is determined in accordance with SOPs for the item. It is documented during IQ or OQ.

Basic IQDetailed OQ based on site SOPsRoutine PQ based on site SOPs

Group B

Analytical balance

Careful with terminology

Group B

Analytical balance

Careful with terminology

Group B

Analytical balance

• Identify vendors that market analytical balances that operate in a range that meets the intended use.

• Identify which models will operate in the desired range.

• Determine if vendor provides desired support.

• Determine if marketed balance performs, in accordance with user requirements and specifications.

Group B

Analytical balance

• Verify that the correct item and accessories were delivered without damage.

• Verify that the area environment is consistent with manufacturers or users requirements and USP <1251>.

• HVAC

• Free of vibration

• Free of air currents

• Low humidity

Group B

Analytical balance

IQ (continued)

• Verify balance is in the appropriate asset control system.

• Verify that appropriate SOPs are in place.

• Operating

• Operational Qualification

• Calibration

• Other, as appropriate

• Performance qualification

• Weight checks

Group B

Analytical balance

IQ (Continued)

• Verify that operators have documented and appropriate training.

• Education, training, experience

• Verify that balance is installed correctly.

• Verify that balance will turn on and execute defined start-up routine.

• Verify that appropriate standards and accessories are in place.

Group B

Analytical balanceOQ

• Verify that balance performs in accordance with USP <1251>

• Mechanical mobility

• Control of stable indication

• Manually triggered or automatic adjustments

• Operation of ancillary equipment

• Tare function

• Calibration

• Sensitivity

• Linearity

• Eccentricity

• Repeatability

• Minimum weight

Group B

Analytical balancePQ

• Perform check weigh procedures

• Perform other items listed in USP <1251>, as appropriate.

Group B

Oven, Refrigerator, Freezer

• Verify that the correct item and accessories were delivered without damage.

• Verify that the area environment is consistent with manufacturers specifications.

• Verify item is in the appropriate asset control system.

• Verify that appropriate SOPs are in place.

• Operating

• Operational Qualification

• Calibration

• Performance qualification

Group B

IQ (Continued)

• Verify that operators have documented and appropriate training.

• Education, training, experience

• Verify that item is installed correctly.

• Verify that item will turn on.

Group B

• Turn on equipment

• Demonstrate that it will come to and hold a defined temperature. (Dependent upon intended use.)

• Where required (dependent upon intended use) map the temperatures throughout the chamber.

Group B

• Monitor controlled parameter.

• Trend the parameter.

Group C

Instruments and computerized analytical systems. User requirements for functionality, operational limits and functional limits are specific to the intended use (the analytical application).

Group C

Atomic absorption spectrometer Differential scanning calorimeter Thermal gravimetric analyzer Dissolution system Electron microscope HPLC GC Mass spectrometer Microplate reader X-ray fluorescence X-ray diffraction Densitometer Elemental analyzer IR and NIR spectrometer Vis/UV Spectrophotometer

Group C

Conformance to user requirements is demonstrated by specific function tests and performance tests.

Installation (and qualification) of the instrument is complicated and may require assistance.

A full qualification process is required.

Group C

Extensive IQ

Extensive OQ – in part based on site SOPs

Routine or continuing PQ, in part based on specific test system suitability, control sample testing or specific site SOPs.

In order to have an effective instrument qualification program, other Quality System systems must be in place and functional. These include:

– Training

– Documentation (policies and procedures)

– Records

– Maintenance

– Calibration

– Deviation

– Investigation

– CAPA

– Control samples

– Total validation program

Implementing the concepts

Qualification of laboratory equipment and instruments is a requirement.

There is no requirement that an organization use the concepts of USP <1058>

If the organization has an adequate, alternate plan –use it.

Design and implement a system for the qualification of laboratory equipment and

instruments!

Implementing AIQ

Validation system

Instrument qualification SOP

Divide all instruments into the three categories.

Establish general procedures for the qualification of instruments in each category.

Establish procedures for specific instrument calibration, performance testing and related activities.

Create a priority list based on risk.

Qualify each instrument according to a plan.

Interactive Exercise

Good Luck!

Questions

For further reference – start with:

A Primer:

Analytical Instrument Qualification and System Verification

By: Ludwig Huber

Agilent Technologies

Laboratory InstrumentQualification

Demonstrate Suitability for use

Jerry Lanese

IVTLaboratory Compliance Week

Contact Information

Jerry LanesePh.D.

913 915 3276

jerry@lanesegroup.com

www.lanesegroup.com

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