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Validation Plan: Validation Plan Equipment Qualification Template
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Table of Contents
Note: fields marked [Company] or [Title], etc. can be updated within the document and should change all other references to the field instantly. All text provided is either instructional (red text) or example (black text) and should be modified/deleted as appropriate.
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1.
Introduction Company Name
manufactures <product categories> at the Company Address site.
This opening sentence may be enhanced by other relevant and specific terminology which can help set the tone of the document. Terms which have immediate implications for the scope of validation, such as API, aseptic, liquid, solid dose, contract manufacturer, packaging, sterile, non-sterile, medical device, etc. can be useful here. Subsequent to the opening sentence, the introduction should provide reasons for the project (new facility, new process, equipment failure and repair, etc.) as well as (potentially) references to the scope and approach if useful (eg retrospective/concurrent nature or other differentiating feature)
2.
Scope
2.1.
In Scope This plan is relevant for all equipment qualification associated with Validation Plan Equipment Qualification Template at Company Name’s Company Address site. It defines the broad validation rationales, relevant quality systems and provides guidance and planning of validation and qualification activities. In some cases, it may be useful to provide a bullet list of the relevant systems/equipment in the scope of the document. This is most useful when the scope is not intended to cover every item related to the project. Specifically, the plan covers the following systems/equipment HVAC Purified Water Water for Injection Compressed Air
2.2.
Out of Scope When expressing what is out of scope, it is only pertinent to describe items which could reasonably be expected to be part of the scope. Exclusion of items not associated with the project, or those which don’t require qualification is not necessary. Out of scope items should always include a reference to the plans/protocols that do cover them. (If they don’t need a plan or protocol, they don’t need to be described in the out of scope section). All equipment qualification requirements associated with Validation Plan Equipment Qualification Template are included. There are no out of scope items. OR The plan does not cover the following systems/equipment associated with the Validation Plan Equipment Qualification Template.
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Backup power system (covered under VPXXX) Computer systems (covered under VPXXX) Etc. AND/OR The plan does not include the following aspects of qualification certain items within the scope: Installation and Operational Qualification of the Purified Water System, previously completed under IQXXX and OQXXX. Protocol development and execution for Ultrafiltration unit XXX, which will be performed by the vendor. Refer to section XXX for further details.
3.
Validation Activities Where possible, all validation and qualification should be performed prospectively. There are a few exceptions where concurrent work is acceptable (medical need for product, low frequency of batches) and even fewer where retrospective work is acceptable <as remediation for an identified deficiency only – retrospective validation must never be preplanned>. Detailed justification for any retrospective or concurrent work should be provided here. All required qualification for the new facility will be conducted retrospectively/concurrently/ prospectively to provide assurance of the suitability of the systems and equipment to their function. For equipment, facility and systems, the level of qualification required is assessed in this plan in Section 4.1. For processes, procedures and methods, the validation rationale is defined in section 4.3 The qualification activities will be comprised of:
3.1.
Design Qualification (DQ) The DQ will verify the final design against the user, functional and/or design specifications to ensure that all specified design elements have been included and that the design meets the relevant regulatory and statutory requirements. The DQ will be conducted prior to delivery/construction/practical completion/FAT to enable modifications if necessary. The following DQs will be performed as part of this plan Document ID DQR001
Document Title Facility Design Review
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3.2.
Installation Qualification (IQ) The IQ aims to verify that the equipment/system/process is: installed correctly, in accordance with manufacturer’s and statutory guidelines, compliant with Company Name’s requirements for supplied documentation, materials of construction, capacity, design and component types, integrated into Company Name’s quality systems for calibration and maintenance available for use The following IQs will be performed as part of this plan Document ID
Document Title
IQ001
Facility Installation Qualification
IQ002
HVAC System Installation Qualification
IQ003
Purified Water System Installation Qualification Etc
3.3.
Operational Qualification (OQ) The OQ aims to verify that the equipment/system/process is: operating in accordance with manufacturer’s specifications, compliant with Company Name’s requirements for functionality, integrated into Company Name’s quality systems for operation, training and monitoring The following OQs will be performed as part of this plan Document ID
Document Title
OQ001
Purified Water System Operational Qualification
OQ002
HVAC System Operational Qualification Etc
3.4.
Performance Qualification (PQ) The PQ aims to verify that the equipment/system/process is: Continuously meeting Company Name’s performance criteria for routine use Performing adequately for routine use in commercial production The following OQs will be performed as part of this plan Document ID
Document Title
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PQ001
Purified Water System Performance Qualification
PQ002
HVAC System Performance Qualification Etc
4.
Validation Approach
4.1.
General Approach For all systems, qualification protocols will be prepared in accordance with the criticality assessment in table 4.2. IQ execution will comprise physical inspection of the installation to confirm correct installation and equivalency with existing documentation and drawings. The relevant calibration and maintenance systems will also be reviewed to ensure that the system is adequately integrated. OQ execution will comprise review of existing commissioning and testing data and review of relevant training and procedural documentation. In addition required operating parameters will be confirmed where this has not occurred during commissioning. OQ will normally be conducted without product. PQ execution will comprise testing of the required performance parameters during simulation of normal operating conditions. PQ may be conducted with product, or with a physically similar substitute. For retrospective qualification, this section may refer to the review of historical data.
4.1.1.
Acceptance Criteria
Acceptance criteria are defined in each protocol. If all criteria in a protocol are met, the qualification will be deemed successful and the handover approved. Where criteria are not met, the failure must be assessed in accordance with section 6.2 before any disposition of the protocol.
4.2.
Criticality & Risk Assessments Criticality assessments have been performed in accordance with VMPXXX - Site Validation Master Plan, and SOPXXX – Criticality and Risk Assessment for Validation , for each equipment item, and are documented in the following URS documents: Document No.
Document Name
URS123
Facility & HVAC URS
URS124
Purified Water System URS
URS125
Compressed Air System URS
URS126
Process Pumping Systems URS
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The table below indicates the scope of qualification required for each item based on its criticality and risk assessment: Equipment
Impact
Highest Risk Priority
Qualification Requirements
HVAC
Direct
High
IQ, OQ, PQ
Purified Water
Direct
High
IQ, OQ, PQ
Compressed Air
Indirect
Medium
IQ1
Distribution Pump
Direct
Medium
IQ, OQ
Facility
Indirect
Low
IQ
As per the VMP and SOP instructions, the omission of optional testing must be justified Note 1: In accordance with SOPXXX, OQ is optional for the compressed air system. OQ will not be performed on the system as its effective operation will be verified through the operation of the equipment it services.
4.3.
Qualification Rationale If there is any general statements to be made about the approach to be taken that relate to all aspects of the qualification, it should be included here. It may also be useful to reference any specific guidance methodologies – eg GAMP, or other industry body guidance. For retrospective work, it may be possible to minimise the scope of the qualifications as some of the testing may be self-evident (some tests are redundant if the equipment has been successfully operating. The qualification rationales for each equipment/system are detailed below:
4.3.1.
Purified Water
If validation risk assessments have been performed, it can be very useful to refer to them here, the text below assumes that the risk assessment provides sufficient detail and justification for the position: URS124 – Purified Water System identified 3 requirements with a high risk priority. As a result, the qualification protocols will place additional focus on the following risks: Cleaning records (U13) Materials of construction certification (U25) Pipework design (U44)
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4.3.2.
2-8°C Refrigerator
There may also be specific rationales which are not directly related to risk management, such as which standards are applied and other testing requirements. These will usually be detailed within the relevant protocol, but can be summarised here if desired. Examples are given below: The Refrigerator shall be qualified generally in accordance with the ISPE Baseline Guide Volume 5: Commissioning and Qualification (note: this guide is just an example – there is no expectation to conform to one guidance or another), except: No DQ will be performed as the system is a standard catalogue model and no additional design was performed. The refrigerator will be subject to 24 hour temperature mapping, as it is located in a temperature controlled environment with little or no seasonal variation.
5.
Roles and responsibilities If a validation project plan sits above this plan in the document hierarchy, it is usually simplest to refer the responsibilities defined in that plan. If not, and validation is essentially the responsibility of one person, the following text is appropriate. The QA Manager is responsible for overseeing and ensuring resource availability for all validation activities. The QA Manager is responsible to designate staff or consultants to write protocols, execute testing and/or write reports. Personnel shall be adequately trained and/or experienced to perform their designated work. Each protocol and report shall be signed by the author and reviewed and approved by (at least) production management and the QA Manager. If more people are routinely involved in validation activities (eg. validation engineer, production staff, other QA or QC staff) a table detailing their responsibilities is useful. Position Validation consultants
Responsibilities Develop user specifications, qualification and validation protocols Execute and/or assist with execution of protocols Write qualification and validation reports
Validation Manager or delegate
Review of documentation to ensure compliance with company validation procedures and acceptance of results Allocation of resources to execute protocols
Operations Manager(s) or delegate(s)
Review of documentation to ensure compliance with equipment/system capabilities and acceptance of results Allocation of equipment/system availability for execution of protocols
Quality Manager or delegate
Review of documentation to ensure compliance with company
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validation and quality procedures and acceptance of results Allocation of resources to execute protocols
6.
Validation Procedures
6.1.
Data Collection Data collection and documentation practice is to be conducted in accordance with current GMPs. The following rules must be adhered to: All written records shall be made in indelible blue or black ink. Only approved copies of the master protocol, or appropriately identified record books shall be used for recording written data Writing errors shall be corrected with a single strike-out line and initialled and dated. An explanation for the correction must be recorded with the strike-out, except where the reason is self-evident (eg spelling mistake). All written records must be recorded with the minimum possible delay after the event by personnel who witnessed the event.
6.2.
Deviations and Deficiency Handling 6.2.1.
Deviations
Any unplanned change from a protocol will be recorded as a validation exception report. The report will include an explanation of the change and the impact on the qualification activities and recommendations as to the action required
6.2.2.
Deficiencies
Failure to meet any acceptance criteria will be recorded in a validation exception report. The report must include a detailed analysis of the causes of the deficiency, the implications to the validation activities and recommendation as to the actions required to address the deficiency.
6.2.3.
Review & Corrective Action
A decision will be made by the QA representative as to the management of the deviation or deficiency and the agreed position documented. Any exception that may have GMP impact on current or future production activities will be documented and reported to QA.
6.2.4.
Identification & Filing
Validation exception reports are numbered as according to the relevant test protocol number with the extension ERXX, where XX is a sequential number starting at 01. For example, the second exception report generated for the first Operational Qualification will be: OQ-001-ER02 Document is current if front page has â&#x20AC;&#x153;Controlled copyâ&#x20AC;? stamped Page 10 of 14
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All validation exception reports are listed and filed within the relevant Protocol. A summary of exception reports and their status will be included in the Validation Summary Report.
6.3.
Change Control 6.3.1.
Pre-Implementation Changes
Minor changes (eg. typographical, spelling, grammatical, clarification, etc) to validation documents prior to completion of the project (ie. sign off of the final validation summary report) will be documented, reviewed and approved through the document change history section at the end of each document. Where a change is required to any validation document, approval is required by the original signatories or their equivalent. Significant changes (eg. change of intent, significant addition or removal of text, methodology changes) to documents prior to project completion will be documented, reviewed and approved through the deviation and deficiency handling detailed in section 6.2.
6.3.2.
Post-Implementation Changes
Post-Implementation changes to documentation should not normally be required. Where equipment is to be retested, protocols should be revised (if necessary) in accordance with the pre-implementation changes above and new reports generated. Changes to reports due to errors or the provision of new information should be made via errata notes and approved by the same level of personnel who approved the original report. The notes should be filed with the original report. Following implementation, changes to equipment or systems will be in accordance with Company Name Change Control procedure.
7.
Reporting
7.1.
Activity Reports Each executed protocol becomes its own report. Each protocol contains a progress approval section which requires the same level of approval as the original protocol. The progress approval section allows for interim progression of a stage when non-critical aspects of a protocol are incomplete. The completion of this final disposition section with the progress approval signifies completion and acceptance of the qualification, subject to any provisions documented in the comments section.
7.2.
Validation Summary Reports (VSR) A validation summary report may be generated for each protocol, or for multiple protocols by stage (eg all IQs) or for the entire plan. It is important to detail how VSRs will be managed and then carry out those instructions. A summary report shall be generated for each protocol/this plan. The summary report(s) shall provide a brief, single point of reference for qualification results and shall provide an
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assessment of the completion status of the qualification and validation work with respect to this validation plan.
8.
Referenced Documents The following documents may assist in the understanding and execution of this plan Document Number
9.
Document Title
Definitions Term/abbreviation
Definition
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Document Information
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Modified by
Change Control No.
Description of Change
01
Complete the above fields for each revision of this document. Ensure that there is sufficient description of changes so that the change history of this document can be followed. Additional columns can be added to include document/change tracking numbers generated by your company’s systems if required (eg. change control).
Associated forms and procedures Doc. No.
Document Title
List all controlled procedural documents referenced in this document (for example, policies, procedures, forms, lists, work/operator instructions
Associated records Doc. No.
Document Title
List all other referenced records in this document. For example, regulatory documents, inhouse controlled documents (such as batch record forms, reports, methods, protocols), compliance standards etc.
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