Scribd Logo
Upload

Welcome to Scribd!

  • 84 views

    16.0 Re-Validation / Requalification

    Uploaded by

    Bhavik Yadav
    The document outlines revalidation requirements for various systems and processes. It specifies that all validated processes, equipment, instruments, analytical methods, cleaning validations, and utilities like air handling units, water systems, gases must be revalidated under certain circumstances. Critical equipment must be revalidated every 5 years and non-critical equipment every 3 years. Analytical methods must be revalidated if methods or specifications change. Cleaning validations must be revalidated if acceptance criteria, procedures, or products change. Air handling units and water systems must be revalidated every 3 years or if the systems undergo major changes.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd

    16.0 Re-Validation / Requalification

    Uploaded by

    Bhavik Yadav
    84 views3 pages
    The document outlines revalidation requirements for various systems and processes. It specifies that all validated processes, equipment, instruments, analytical methods, cleaning validations, and utilities like air handling units, water systems, gases must be revalidated under certain circumstances. Critical equipment must be revalidated every 5 years and non-critical equipment every 3 years. Analytical methods must be revalidated if methods or specifications change. Cleaning validations must be revalidated if acceptance criteria, procedures, or products change. Air handling units and water systems must be revalidated every 3 years or if the systems undergo major changes.

    Original Description:

    Equipment revalidation criteria

    Original Title

    Revalidation Criteria

    Copyright

    © © All Rights Reserved

    Available Formats

    DOCX, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    The document outlines revalidation requirements for various systems and processes. It specifies that all validated processes, equipment, instruments, analytical methods, cleaning validations, and utilities like air handling units, water systems, gases must be revalidated under certain circumstances. Critical equipment must be revalidated every 5 years and non-critical equipment every 3 years. Analytical methods must be revalidated if methods or specifications change. Cleaning validations must be revalidated if acceptance criteria, procedures, or products change. Air handling units and water systems must be revalidated every 3 years or if the systems undergo major changes.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    84 views3 pages

    16.0 Re-Validation / Requalification

    Uploaded by

    Bhavik Yadav
    The document outlines revalidation requirements for various systems and processes. It specifies that all validated processes, equipment, instruments, analytical methods, cleaning validations, and utilities like air handling units, water systems, gases must be revalidated under certain circumstances. Critical equipment must be revalidated every 5 years and non-critical equipment every 3 years. Analytical methods must be revalidated if methods or specifications change. Cleaning validations must be revalidated if acceptance criteria, procedures, or products change. Air handling units and water systems must be revalidated every 3 years or if the systems undergo major changes.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    You are on page 1of 3
    At a glance
    Powered by AI
    The document outlines various events that trigger re-validation or re-qualification of processes, equipment, analytical methods, cleaning validation, air handling units, water systems, compressed gases and raw material vendors.

    All validated processes must be re-validated every 3 years or if there are changes in manufacturing location, chemistry, specifications, batch size or annual product quality review findings.

    Critical equipment must be re-qualified every 5 years and non-critical every 3 years or if relocated or modified. Instrument re-qualification is triggered by relocation, calibration frequency, major part changes or serviceable part replacement.

    16.

    RE-VALIDATION / REQUALIFICATION:

    All
    validated system including equipment, instruments, product, processes, environment,
    analytical method, cleaning, product contact utilities, water shall be re-validated.
    16.1 PROCESS: All the validated process shall be re-validated for the following events,
    16.1.1 All the validated process shall be re-validated after 3 years concurrently.
    16.1.2 Change in manufacturing location.
    16.1.3 Change in the chemistry manufacturing and control.
    16.1.4 Change in specification for quality impacting parameter.
    16.1.5 Change in batch size more than 10 fold.
    16.1.6 Follow of the Annual product quality review, if required.
    .
    16.2 EQUIPMENT:
    All the qualified equipments shall be re-validated for the following events,
    16.2.1 Critical Equipment shall be re-validated every 5 years from date of operational
    qualification completion and subsequent re-validation every 3 years. Critical
    equipments, who directly involved on the product quality i.e. Reactor, Centrifuge,
    Dryer, Multimill and Microniser.
    16.2.2 Re-location of the equipment.
    16.2.3 Any major modification in the existing equipment since last qualified, which
    can have an adverse impact on the equipment or product performance.
    A planner shall be maintained to schedule the requalification.
    The re-qualification shall be carried out as per Annexure-VI, but not limited to.
    16.3 INSTRUMENT:
    All the qualified instruments shall be re-validated for the following events,
    16.3.1 Re-location of the instrument.
    16.3.2 Instrument shall be re-qualified through periodic calibration.
    16.3.3 Incase change of major parts i.e. pump and software shall be re-qualified as per
    recommendation of supplier / manufacturer.
    16.3.4 Incase of serviceable part replacement i.e. detector lamp, pump seal shall be requalified through calibration.
    16.3.5 For Microbiological laboratory like autoclave, incubator and depyrogenerator
    shall be re-qualified every six month.
    16.4 ANALYTICAL METHOD:
    All the analytical method shall be re-validated for the following events,
    16.4.1 Any change in the analytical method, which is beyond the validated parameters.
    16.4.2 Change in specification, due to change in route of synthesis of the drug substances
    or for any other reason.
    16.5 CLEANING VALIDATION:

    16.5.1
    16.5.2
    16.5.3
    16.5.4

    Cleaning process shall be re-validated for the following events,


    Change in the acceptance criteria.
    Change in cleaning procedure along with change the solvent.
    Introduction of new product in the system.
    Change in minimum batch size out put quantity.

    16.6 AIR HANDLING UNIT / LAF:


    All the qualified equipments shall be re-validated for the following events,
    16.6.1 AHU shall be re-qualified after 5 year from the date of operational qualification completion and
    subsequent re-qualification every 3 year.
    16.6.2 Major change / modification in the existing system which affect the performance of the system
    and quality of the Air and requirement for the product.
    16.6.3 Major modification in the room, the AHU shall be re-validated.
    16.6.4 AHU performance also shall be re-qualified at regular interval as defined belowTest
    Frequency
    HEPA filter integrity (DOP) test
    Half yearly
    Non-viable particle count
    Half yearly
    Air Velocity and air Changes
    Half yearly
    Air Pressure differential
    Half yearly
    Airflow Visualization (Smoke Pattern test)
    Annually
    16.6.5

    After shutdown / major modification area shall be qualified for microbiological quality also.

    16.7 WATER SYSTEM (Purified / Process Water):


    16.7.1 Every 3 years shall be re-validated periodically based on protocol.
    16.7.2 If any changes in the system, which may affect the quality of the water.
    16.8 COMPRESSED AIR :
    Compressed Air system shall be re-qualified after 5 year from the date of operational
    qualification completion and subsequent re-qualification every 3 year
    Its performance shall be re-validated half yearly for the following parametersDew Point : -40 oC
    Oil Content : Free
    Moisture
    : <300 ppm
    Limit for microbiological: NMT 50 cfu/ml.
    Incase of major break down. Also the compressed air needs to be qualified.
    16.9 COMPRESSED NITROGEN GAS:
    Compressed Nitrogen Gas system shall be re-qualified after 5 year from the date of
    operational qualification completion and subsequent re-qualification every 3 year.
    Its performance shall be re-validated half yearly for the following parameters-

    Oil Content
    : Free
    Purity
    : NLT 99.0%
    Oxygen Content : Less than 500 ppm.
    Limit for microbiological: NMT 50 cfu/ml.
    Incase of major break down. Also the compressed air needs to be qualified.
    16.10 VENDOR FOR STARTING RAW MATERIAL:
    16.10.1 Any change in the specification of the starting material.
    16.10.2 Change in Route of Synthesis or change in manufacturing location.
    16.10.3 The vendor shall be re-audited every two year.

    You might also like