Equipment Qualification Ensure Fit for Intended Use. IVT Amsterdam Conference Mary Sexton. 19 Mar 2015

Transcription

1 Equipment Qualification Ensure Fit for Intended Use IVT Amsterdam Conference Mary Sexton 19 Mar 2015

2 Equipment Qualification Ensure Fit for Intended Use 1. Types of Qualification 2. Validating Equipment Keep it Simple 3. Interactive Exercise 2

3 Types of Qualification - Definitions Equipment Qualification - Documented evidence that the equipment system meet the installation, operational and performance requirements to meet user requirements and consistent product quality. Equipment System - The main item of equipment (e.g. Reactor) together with associated ancillary equipment, piping and instrumentation. User Requirements Document approved by the User group (system user and/or customer) and Quality Unit (as a minimum), indicating requirements to ensure quality of product. Critical requirements should be distinct from other desired characteristics. 3

4 Types of Qualification The purpose of an equipment system qualification is to demonstrate that the system is installed, operating and performing as per the user requirements prior to production handover. Qualification is made up of the following components: Commissioning Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) The concepts of commissioning, IQ, OQ and PQ apply to all equipment and utility systems. The equipment systems must be properly designed, installed, and tested. Testing must be planned, and the level of testing (e.g., commissioning, qualification) must be appropriate and based on the patientandqualityproducttoimpactpotentialsystem s/equipment 4 safety. 4

5 Types of Qualification Commissioning: It is where every operational component of the project is inspected and tested, from individual functions, such as instruments and equipment, up to complex amalgamations such as a water system. Commissioning activities are applicable to all phases of the project, from the basic and detailed design, construction and assembly. Commissioning occurs prior to Installation Qualification. The commissioning process shall challenge the equipment system to ensure it will operate as specified throughout the required range in accordance with design requirements and user requirements. This ensures the equipment / system is ready either for operation (Indirect and No Impact systems) or for IQ, OQ, PQ (Direct Impact systems), as applicable. 5

6 Types of Qualification No Impact Systems are not expected to have any impact on product quality. Such systems are designed and commissioned. Examples include HVAC air supply in a general plant area. Indirect Impact Systems are not expected to have a direct impact on product quality, but typically will support a direct impact system. Such systems are designed and commissioned. Examples include jacket heating system to a reactor. Direct Impact Systems (i.e. systems that could have a direct impact on product quality) are designed, commissioned and IQ, OQ, PQ. A system does not have to be product contact to be defined as direct impact. Direct impact include to clean/sterilise, preserve product stability, produce data which can be used to accept or reject product, or serve as a process control system that may affect product quality. 6

7 Types of Qualification Installation Qualification (i.e. IQ): It is the documented evidence that the equipment system has been delivered and installed in accordance with the user requirements. The documentation for an Installation Qualification normally consists of: IQ test plan/protocol: Contains detailed information of the critical installation tests to be performed on the equipment system. IQ summary report: After completion of the Installation Qualification IQ, the results are summarised, evaluated and compiled in an IQ report. All deviations, as well as measures taken to eliminate these, are documented. After the deviations have been eliminated, these must be tested again, documented and evaluated in a new IQ report. 7

8 Types of Qualification Operational Qualification (i.e. OQ): It is the documented evidence that evaluates the correct functioning of the critical operational components of the equipment system. Testing shall include but it is not limited to control system security requirements, emergency power etc. During the OQ, all items specified in the test plan are processed and documented in writing, to ensure that the critical operation system functions in accordance with specifications. The documentation for an OQ normally consists of: OQ test plan/protocol: Contains detailed information of the critical operational tests to be performed on the equipment system. OQ summary report: After completion of the OQ, the results are summarised, evaluated and compiled in an OQ report. All deviations, as well as measures taken to eliminate these, are documented. After the deviations have been eliminated, these must be tested again, documented and evaluated in a new OQ report. 8

9 Types of Qualification Performance Qualification: It is the documented evidence that the equipment system (i.e. Water, Nitrogen) is working reproducibly within the entire specified working range and limits over a certain period of time. The documentation for a PQ normally consists of: PQ test plan/protocol: Contains detailed information of the critical performance tests to be performed over a certain period of time. A sampling plan with acceptance criteria is typically included in a PQ test plan/protocol. PQ summary report: After completion of the PQ, the results are summarised, evaluated and compiled in a PQ report. All deviations, as well as measures taken to eliminate these, are documented. After the deviations have been eliminated, these must be tested again, documented and evaluated in a new PQ report. Once the PQ summary report is signed, the system can be released for production and routine testing. The routine monitoring must begin 9 immediately.

10 Types of Qualification Note: Not all equipment systems require a PQ and it is sufficient to release the equipment for production use post the execution of the OQ. A PQ is typical required for Water, HVAC and Nitrogen systems The key tests associated with commissioning, IQ, OQ and PQ must be done in the correct order, pass and be reviewed prior to doing any other test that the current test may affect. The FDA has stated that they are not as concerned about where each test is included as long as they are done in proper order for the individual tests, so that a subsequent failing result does not affect a previously approved test. 10

11 Select type of qualification required The extent of this qualification will vary depending on the specific function of the equipment and its impact on product or processes. System Impact Assessment is a formalised method to determine the extent of qualification required. This assessment is performed during the early stages of the project. Impact Assessments must include personnel from appropriate areas (e.g. Engineering / Project Personnel, Business Area /Customer and Quality Unit) If the equipment system is deemed as a direct impact system then commissioning, IQ, OQ and PQ will require execution. If the equipment system is deemed as an indirect or no impact system then commissioning will required execution. 11

12 Select type of qualification required Business Area / Customer and Quality Unit must review and approve the Impact Assessment For modifications to existing equipment systems, the impact assessment should be conducted and documented as part of the site change control procedure. 12

13 Setting Acceptance Criteria Commissioning Test instrumentation used for IQ, OQ, PQ activities must be calibrated or standardised, as appropriate, and traceable to national standards. FAT and SAT Completed. FAT (i.e. Factory Acceptance Test): It is the documented evidence of the testing of all functional requirements at the factory prior to shipment to the customer. The FAT will be reviewed and approved prior to shipment. SAT (i.e. Site Acceptance Test): It is the documented evidence required to verify system performance as installed at the site as part of the commissioning activities. This should include testing of the alarms and interlocks. All instruments should be calibrated and loop tuning functions completed before execution. System instrumentation used for IQ, OQ, PQ activities must be calibrated as appropriate. Alarms installed as per user specifications. 13

14 Setting Acceptance Criteria Emergency backup checks Existing or draft procedures (e.g. operating, maintenance and calibration procedures) are to be referenced in the protocol. Pipe slopes shall be verified to ensure lines are fully drainable. Updating Process and Instrument Drawings (i.e. P&IDs) Documents identified as required in the approved protocol must be referenced. All deviations must be addressed before close out of the summary report. Executed commissioning documents, together with their associated summary reports. 14

15 Setting Acceptance Criteria IQ Include a description of the equipment system that includes critical installation requirements. Verify that commissioning, where required, was completed successfully. Confirm information about each unit of key equipment and verify the location of the relevant documentation. Testing of the equipment system and ensuring installation was performed correctly Testing of manufacturer documentation for conformity. Material of Construction certificates ISO Drawings Document that the installation has been reviewed against available as-built drawings (schematic or P&ID) to ensure that they reflect the current as-built condition. 15

16 Setting Acceptance Criteria Surface Finish Reports. Passivation Reports. Flushing Reports. Confirm that equipment and GMP-critical instrumentation are clearly identified in the field and conform to the descriptions provided in the appropriate section of the protocol. Confirm that lubricants with potential product contact are included on site listing or are approved for use. Include spare parts listings for critical equipment or reference their location. Confirm that field or factory calibration certificates are available for instruments. 16

17 Setting Acceptance Criteria OQ Critical operating parameters, equipment function, and the sequence of operation of the equipment must be verified / tested. Where appropriate, water or placebo material may be used to conduct the OQ. If appropriate, the operational ranges of testing should include a set of conditions encompassing upper and lower operating limits (boundary testing). Preventative Maintenance (PM) and Calibration procedures are available. All GMP-equipment requiring regular scheduled PM and all GMP-Critical Instruments must be verified as being included on the PM schedule or on the Critical Instrument List. 17

18 Setting Acceptance Criteria Alarm, Interlock and Security Checks meet critical design requirements. Documented evidence of operating personnel being instructed on procedure requirements. List of all procedures required to be approved at the end of the OQ. List of all procedures required to be approved at end of the PQ (i.e. sufficient to be in draft status at this stage of the project). Inspection of temperature, pressure control and control fluctuations Inspection of the over/under temperature protection alarm systems Emergency power 1 week sampling plan with acceptance criteria if applicable. See section on sampling plans for more details. 18

19 Setting Acceptance Criteria PQ Capture normal operating conditions. Be carried out over an appropriate period of time. Have a predetermined and approved sampling strategy defining sampling locations and frequency. See section on sampling plans for more details. Approved operating, quality and maintenance procedures to ensure seamless transition into routine monitoring Documented evidence of operating personnel being instructed on operating equipment Predetermined acceptance criteria. 19

20 Sample plans for OQ and PQ (Water) Sampling plans are required for the OQ and PQ. For the Water OQ, a 1 week sampling plan would typically be required. The water system is not allowed to be used for production purposes during this timeframe. For the PQ, a 1 month sampling plan would at least be required. If required, the water system can be used by production after the first week of the PQ on only a risk basis. When the PQ summary report is signed, the water system is then only handed over to production for commercial purposes. Each project must determine the appropriate sampling schedule based on system design, modification and historical data where applicable. The project engineer must prepare a sampling prior to commencing the OQ. Sampling plan is based on a risk based approach. 20

21 Sample plans for OQ and PQ (Water) Below is a list of factors that impact the sampling frequency in a water system sampling plan: Microbiological verses Chemistry sampling: Typically in a water system, there are more problems in relation to microbiological rather than chemistry. Therefore, more emphasis is placed on taking microbiological samples as part of the sampling plan. Grade of water: Purified water is a higher grade than municipal water and hence a more detailed sampling plan would be required for a purified water system. Water point classification based on production requirements: A water point used for production purposes would be sampled more frequently than a water point used for cleaning the equipment internally. 21

22 Sample plan for OQ (Water) Municipal Water Microbiological Chemistry Generation (new) Input and each sample Input and each sample point/day point 3 times Distribution (new) Supply/return sample Supply/return sample point every day point every day Critical sample point Critical sample point 3 every day times Non critical sample point Non critical sample point 2 times 1 times Purified Water Microbiological Chemistry Generation (new) Input and each sample Input and each sample point/day point 3 times Distribution (new) Supply/return sample Supply/return sample point every day point every day Critical sample point Critical sample point every day every day Non critical sample point Non critical sample point 22 3 times 2 times

23 Approval of new procedures Commissioning Equipment, Training & Maintenance Procedures should be approved at the end of commissioning for indirect and no impact systems and in draft status for direct impact systems. IQ Spare Parts Listing should be approved at the end of the IQ. OQ Preventative Maintenance, Calibration & Analytical procedures should be approved prior to commencing. PM schedule, Critical Instrument List, Equipment, Training, Operation & Maintenance procedures should be approved by the end of the OQ. PQ Sampling, Ongoing Monitoring, Training & Investigation procedures should be approved 23 at the end of the PQ.

24 How to check if re-qualification is required for modifications? Any changes to the equipment system may require re-qualification. The extent of requalification shall be established based on the type of modification (i.e. Impact the function or structure of a component which directly impacts product quality) and historical performance. Examples include : Deliver a critical process function (e.g. agitator, temperature, PLC operation). Control, measure, record a critical process parameter. Contact the product (e.g. piping materials, o-rings, seals). Requalification sampling plan shall be prepared and approved if required. 24

25 How to check if re-qualification is required for modifications? Repairs using identical replacement parts are not considered changes. It may be appropriate to perform specific challenge tests. For example calibration of a replacement instrument may be required before the equipment system is returned to production use. Changes made using a non-identical, but functionally equivalent may.i.e)replacements likelike-for astoreferredare,component be produced by a different manufacturer). Such changes are to be evaluated by Engineering and the Customer and may not require requalification. 25

26 How to check if re-qualification is required for modifications? componentsorequipmenttoapplynotdoeschange Like-for-like with direct product contact or affecting critical installation or operational requirements. These are subject to site change control procedures. 26

27 Interactive Exercise Water PQ Protocol 27

28 Questions? LinkedIn contactable gmail.com Questions? 28