Valididazione IQ OQ PQ

  • Eseguiamo convalide di processo con metodologia IQ OQ PQ in ottemperanza alle norme cGMP.

    L’Annex 15 del EU GMP fornisce le linee guida per IQ OQ PQ convalida. Tutte le attività di convalida devono essere pianificate. Gli elementi chiave di un programma di convalida devono essere chiaramente definiti e documentati in un piano generale di convalida (VMP) o documenti equivalenti.

    Il VMP deve essere un documento di sintesi, breve, conciso e chiaro. Il VMP deve contenere dati almeno i seguenti:

    (a) validation policy;
    (b) organisational structure of validation activities;
    (c) summary of facilities, systems, equipment and processes to be validated;
    (d) documentation format: the format to be used for protocols and reports;
    (e) planning and scheduling;
    (f) change control;
    (g) reference to existing documents.

    iq oq pq diagram

    Lo scopo di un DQ validazione / IQ / OQ / PQ è quello di documentare e testare la composizione, il funzionamento e le prestazioni della macchina / processo o di prodotto in questione.

    Il Protocollo di Validazione viene redatto secondo le linee guida GMP (Good Manufacturing Practice) e GAMP 4 (Good Automated Manufacturing Practice) nate ed utilizzate per il settore farmaceutico.

    Attualmente anche il settore dei dispositivi medici e quello dei cosmetici stanno adottando tali linee guida al fine di ottenere uno standard qualitativo elevato delle macchine che realizzano, manipolano e confezionano prodotti rivolti ai suddetti settori merceologici.

    Di seguito alcune definizioni atte a chiarire l’ambito applicativo delle diverse fasi di validazione:

     

    Design Qualification

    The first element of the validation of new facilities, systems or equipment could be design qualification (DQ). The compliance of the design with GMP should be demonstrated and documented.

    Installation Qualification
    Installation qualification (IQ) should be performed on new or modified facilities, systems and equipment. IQ should include, but not be limited to the following:
    (a) installation of equipment, piping, services and instrumentation checked to
    current engineering drawings and specifications;
    (b) collection and collation of supplier operating and working instructions and
    maintenance requirements;
    (c) calibration requirements;
    (d) verification of materials of construction.

    Operational Qualification
    Operational qualification (OQ) should follow Installation qualification. OQ should include, but not be limited to the following:
    (a) tests that have been developed from knowledge of processes, systems and equipment;
    (b) tests to include a condition or a set of conditions encompassing upper and lower operating limits, sometimes referred to as “worst case” conditions.
    The completion of a successful Operational qualification should allow the finalisation of calibration, operating and cleaning procedures, operator training and preventative maintenance requirements. It should permit a formal “release” of the facilities, systems and equipment.

    Performance Qualification
    Performance qualification (PQ) should follow successful completion of Installation qualification and Operational qualification. PQ should include, but not be limited to the following:
    (a) tests, using production materials, qualified substitutes or simulated product,
    that have been developed from knowledge of the process and the facilities,
    systems or equipment;6
    (b) tests to include a condition or set of conditions encompassing upper and
    lower operating limits.
    Although PQ is described as a separate activity, it may in some cases be appropriate to perform it in conjunction with OQ.

    Evidence should be available to support and verify the operating parameters and limits for the critical variables of the operating equipment. Additionally, the calibration, cleaning, reventative maintenance, operating procedures and operator training procedures and records should be documented.

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Der Zweck einer Validierung DQ / IQ / OQ / PQ ist es, die Zusammensetzung, den Betrieb und die Leistung der Maschine / des Prozesses oder des betroffenen Produktes zu dokumentieren und testen.

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