Regulatory Open Forum

 View Only

  • 1.  OQ/PQ

    This message was posted by a user wishing to remain anonymous
    Posted 20-Sep-2021 09:32
    This message was posted by a user wishing to remain anonymous

    Hello RA group,

    I am bit curious to understand in what cases we do not require OQ/PQ for a manufacturing site move. Are these related to process output verification? or, do we have any guidance around this?

    Thanks!


  • 2.  RE: OQ/PQ

    Posted 20-Sep-2021 11:23
    Hello,

    Per 21 CFR 820.75, the QS/GMP does not require the validation of all manufacturing processes.  However, the output requires verification via an inspection or test.  What does your SOP state?

    ------------------------------
    Gretchen Upton
    RAC, CQA, CCRP
    QA/RA consultant
    San Antonio, TX
    ------------------------------

    Original Message


  • 3.  RE: OQ/PQ

    Posted 20-Sep-2021 19:35
    If the output can be verified by subsequent monitoring or measurement, then the consideration should be made as to whether or not verification alone is sufficient to eliminate unacceptable risk and is a cost effective solution. If yes, the output should be verified and the process should be appropriately controlled. 

    If the output of the process is not verifiable then the decision should be to validate the process. Also, a change in a manufacturing process may result in the need for process validation even though the process formerly only required verification and control.

    Refer to the GHTF SG3 - QMS - Process Validation Guidance -January 2004 (imdrf.org) for more details.

    ------------------------------
    Ajit Basrur
    Worcester MA
    United States
    ------------------------------

    Original Message


  • 4.  RE: OQ/PQ

    Posted 21-Sep-2021 12:36

    Ditto the prior comments that process validation (i.e., PQ) is only required for those processes (traditionally called "special" processes) the output of which can't be fully verified.  I'll presume that your mention of PQ indicates that such processes are the subject of the question.

    In short, such a process may need additional OQ due to a relocation, and will typically always require some amount of PQ due to a relocation.  Here's more background for this:

    When considering the need for supplemental OQ and/or PQ for a manufacturing site move, it's important to:

    a) properly consider the fundamental and distinct purposes of OQ and PQ; and
    b) apply a risk-based approach to screen the nature and complexity of the relocated process so as to fashion a proper OQ/PQ strategy.

    Remember that in plain terms, OQ is a process exploration, characterization, and development exercise.  More technically, it's where we establish process control limits and action levels that have the fundamental attributes to result in product that meets predetermined requirements.  Accordingly, if the relocation doesn't affect these attributes, then that opens the door for a justification that OQ doesn't need to be repeated.

    But as mentioned above, some level of PQ is typically always required and expected after relocating a special process.  In plain terms, PQ's basic purpose is to assure that the process developed during OQ is sufficiently robust and capable.  It is about the process's ability to repeatably / consistently achieve the desired result.

    Combine the proper consideration of these principles with a risk-based approach in order to ultimately determine whether or not OQ needs to be repeated/supplemented, and to determine how much PQ needs to be done for a relocated special process.



    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 5.  RE: OQ/PQ

    Posted 21-Sep-2021 13:08

    I infer this is device manufacturing.

    In the traditional model a manufacturer performs process validation for those production processes where the output is not fully verified. Typically, this means product verification using a sampling plan (or no product verification). The most common approach uses the IQ/OQ/PQ paradigm.

    When moving a manufacturing site, people ensure that the equipment move is successful and often use the term "validation". I don't like to use verification or validation without a corresponding adjective to avoid confusion; let's call this equipment validation.

    The first thing to check for the equipment validation is in 820.70(g) Production and Process Controls -- Equipment. Ensure you meet all the requirements at the new location. In addition, in the US, be sure to meet all the OSHA requirements on Lock-Out/Tag-Out and on Machine Guarding.

    IQ deals with the equipment's installation. At a minimum it should include 820.70(g) and OSHA requirements. I also recommend maintenance supplies (MRO) as well as maintenance schedules and maintenance SOPs. It should all have been in place before the move, check that that it still works after the move. Develop an IQ checklist for each piece of equipment.

    If you had a validated process before the move then you have one after the move. OQ determines the input settings to the process (where to set the knobs on the machine) and should not change after the move. PQ determines that the process operates correctly at established points. Often PQ uses a sampling plan that has more samples. I recommend that you repeat the original PQ as a check that the move was successful.



    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 6.  RE: OQ/PQ

    Posted 21-Sep-2021 14:42
    Edited by Kevin Randall 21-Sep-2021 17:43

    My understanding is that the FDA, the GHTF/IMDRF, ISO/TC 210, and others like AAMI, all recognize that a manufacturing site move can most definitely lead to a scenario where, if you had a validated process before the move, then you WON'T have a validated process after the move.  For example, the GHTF states that a "transfer of processes from one facility to another" may warrant revalidation.  AAMI also states that a relocation can cause the need for revalidation, for example when water quality (think steam sterilization), air quality, facility size (think capacity and build sizes/volumes) change.

    I betcha we can find FDA Warning Letter citations or 483 Observations citing a failure to revalidate a process after a relocation; I'll have look into my past to see if I can find an example of such an FDA citation/observation.

    With such a large cloud of expert witnesses indicating that relocations can require revalidation, I think we should be careful not to dismiss that need.

    Some real-world examples of relocation scenarios that would require revalidation are:

     

    • Moving a sterilization process to a facility with higher bioburden (often associated with moves to warmer, more humid environs).
    • New process operators at the new location can also trigger the need for revalidation.
    • Relocations may involve different raw material sources or suppliers, which can demand the need for revalidation.

    But getting back to the original question (i.e., in what cases do we NOT have to do revalidation after a move):  I think it's risky to try and create boilerplate / universal rules governing when we DON'T need to revalidate after a move.  It seems to make more sense to be able to determine when we DO need to revalidate.  And that needs to be determined for each process on a case-by-case basis in the relocation master validation strategy.  As noted above, my experience has been that some degree of revalidation is typically expected after a move.  But there are certainly going to be cases, maybe many, where we can justify otherwise.  I'll step aside and let others offer some examples of where revalidation is NOT required after relocation.



    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 7.  RE: OQ/PQ

    Posted 21-Sep-2021 14:00
    The GHTF Guidance is a good place to begin.  But your company policies and procedures should define when IQ, OQ, and PQ are required and the recommended activities for each.  I recommend establishing A Master Validation Plan to identify which equipment and processes require IQ, OQ, and PQ with rationale for exceptions.

    Installation, Operational, and Performance Qualifications are separate activities with different objectives and outputs. In general, IQ and OQ activities fall under 21 CFR Parts 820.70 - Production and Process Controls and Parts 820.72 - Inspection, Measuring, and Test Equipment.  Where as, PQ generally falls under Parts 820.75.  

    Installation qualification (IQ) is defined as "Establishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer's approved specification and that the recommendations of the supplier of the equipment are suitably considered."  Typical activities and outputs of IQ include verification of installation conditions such as, wiring and utilities, fit and basic functions, environmental conditions, calibration, safety features; verification supplier documentation is stored in a controlled location; establishment of PM and cleaning schedules.
     
    Operational qualification (OQ) is defined as establishing by objective evidence process control limits and action levels which result in product that meets all predetermined requirements.  Typical activities and outputs of OQ include verification of equipment controls, alarms, interlocks, and defect management systems; software installation and functionality; evaluation of equipment functionality over defined operating ranges (i.e., boundary conditions) to verify equipment can maintain operations within process specifications.

    The division of activities and outputs from IQ and OQ are not hard and fast and will differ among companies.  It doesn't matter how they are grouped, just that they are done.  I expect all equipment will have IQ and OQ records.  The complexity of the records will vary based on equipment.

    Performance qualification (PQ) is defined as "Establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements."   Typical PQ activities include include evaluation of process stability and capability, verification or validation that equipment produces acceptable product over a range of operating conditions and disruptions (e.g. start-up, shut-down, emergency stop and restart, maintenance, tooling changes, shift changes,...). Not all equipment or processes require PQ.  However, all validated processes require IQ, OQ, and PQ.




    ------------------------------
    Wayne Schrier
    ------------------------------

    Original Message


Related Content