The Complete Validation Toolkit
The Validation Toolkit The Validation Toolkit is the answer to those who are either new to Validation, or those who want a simplified start to a validation approach. Pharmi Med Validations have used all their experience to piece together the essential components of a successful Validation system for both Medical Device and the Pharmaceutical industries; this toolkit will work. It outlines the essential requirements as sought by both the FDA and the MHRA. A Validation system may have more components than what is provided here based on individual system requirements. For further assistance if you are unsure if this will suffice your requirements, please contact a consultant in the contact us page. The Validation Toolkit is a comprehensive 100 page document which encompasses all your requirements for start up validations. Your company policy and approach to Validations will be clarified in the Validation Master Plan. You will then specify your request of any equipment is this toolbox is being used for new equipment purchase, for instances where equipment is already purchased you do not need to complete this stage. You will then outline individual Validation Plans for equipment, process and systems using the Validation Plan template. Once all stages have been planned and documented the Installation Qualification must be written using the checklist provided in this toolbox. Following on from successful Installation you will need to check all your operational requirements and functionality and set parameters using methods such as Design of Experiments or an FMEA (Failure Mode Effect Analysis). You will need to ensure outer limits are established and documented here with objective evidence to support this. After successful OQ you will then need to perform a PQ, Performance Qualification using three consecutive batches with successful results. After you have completed your PQ, essentially you have covered all qualification requirements and you will need to summarise this using the summary report template provided in the toolkit. Validation Master Plan, URS, Validation Plan, FAT, IQ, OQ, PQ, Summary Report
Contents 1. 2. 3. 4. 5.
What is Validation?.............................................................................. Your Standard Operating Procedures – SOPs.................................... Your Master Validation Schedule – controlling your programme...... Your Validation approach – Validation Master Plan/Policy............... .. What are you ordering/validating – writing a User Requirements...... Specification 6. Your supplier response – FDS or similar................................................. 7. Testing what you have ordered before it is shipped – FAT.................. 8. Installing your equipment – Installation Qualification............................ 9. Checking the limits - Operational Qualification...................................... 10. Performing consistency – Performance Qualification........................... 11. Summarising your reports......................................................................... 12. SOP Template.......................................................................................... 13. Validation Master Plan/Policy Template.................................................. 14. URS Template.......................................................................................... 15. FAT Template........................................................................................... 16. Validation Plan Template.......................................................................... 17. IOPQ Template......................................................................................... 18. Summary Report Template.......................................................................
Page 5 5 5 5 6 6 6 6 7 7 8 9 12 24 36 55 59 95
Validation Master Plan – Your company policy on Validation approach
User Requirements Specification – Specify your needs
Validation Plan – Document your Validation Method and specific plan here
FAT – Factory Acceptance Testing (Test all requirements at supplier site
Installation Qualification (IQ) Document your installation requirements
Operational Qualification (OQ) Document all Operational/Functionality Checks
Performance Qualification (PQ) Document Performance consistency
Summary Report Summarise all your validation findings
Written By:
Other references
Revision: 01
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Reference your document here
User Requirement Specification FOR [NAME HERE] Document Title: (further description here)
Your Logo
Protocol Approval
Print Name
Signature
Date
Print Name
Signature
Date
Production Engineering
R&D Regulatory Affairs Quality Assurance
Execution Approval
Production Engineering
R&D Regulatory Affairs Quality Assurance
CONTENTS
Page No.
Management Topics 1.0 2.0 3.0 4.0 5.0 6.0 7.0
Introduction……………………………………………………………… Identification of organisation’s goals and objectives………… Expected benefits…………..………………………………………… Budget and resources …………………………………………….. Time, security, procedural and maintenance constraints…… Existing infrastructure, policies and practices………………… Contract and Services agreement ……………………………..
Operations Topics 8.0 9.0 10.0 11.0 12.0
Intended equipment usage……………………………………… Environmental constraints ……………………………………… Profile of users ………………………………………………….. Modes of operation……………………………………………… Desired functionalities ………………………………………….
Equipment Topics 13.0 14.0 15.0 16.0 17.0 18.0 19.0 20.0
Production and quality performance………………………….. Components assembly and construction …………………… Operators and external systems interface …………………. Alarms, events, messages and reports……………………... Training, maintenance and qualification documentation….. System backup and restore………………………………….. General Requirements…………………………………… Validation………………………………………………………
Management Topics 1.0 Introduction [enter an introduction of the equipment/process in question here]
2.0 Identification of organisation’s goals and objectives This specification provides for the supply, delivery, commissioning and validation of a [enter equipment here]. The [enter equipment here] is installed and operated within the [enter are of operation here] of Your company. FDA 21 CFR:
Each manufacturer shall ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use
3.0 Expected benefits
The expected benefits of the system are that the [explain the system benefits here]. For example - the XXX system will improve safety, maintain high plant production availability, optimise the use of detergent and water, and allow the difficult areas to be cleaned.
4.0 Budget and resources The budgets for this system have been allocated, two people currently run the liquid manufacturing area and the system installation and operation will run as present. The XX system is a programmed system and runs on a set programme. The Engineers have responsibility to troubleshoot and diagnose any faults in the hardware or software. 5.0 Time, security, procedural and maintenance constraints The Validation must be complete according to the Validation Master Plan XXXX Project Time plan Appendix XX. The security of the system is administered by the System Administrator who will assign user name and passwords to those needing them. The procedure shall be updated by the Engineer responsible as will maintenance. The system itself is designed to be maintenance free. However maintenance is the responsibility of the
Factory Acceptance Testing (FAT) Protocol for (Enter description here) Document Ref: (enter here)
Version: 1.0
Effective Date: (enter date here)
FAT PROTOCOL AUTHORISATION Name/Title Prepared by
Author
Reviewed by
Engineering
Reviewed by
QA
Reviewed by
Production
Reviewed by
Planning (if required)
Signature
Date
Signature
Date
FAT PROTOCOL REPORT AUTHORISATION Name/Title Completed by
Author
Reviewed by
Engineering
Reviewed by
QA
Reviewed by
Production
Reviewed by
Planning (if required)
Brief Description:
Enter Description Here of equipment for installation and place of installation
Objective:
To ensure the (enter equipment here) fully complies with the requirements of the purchase specification (enter details here) dated (enter date here), and that the machine is accepted for delivery to (enter your details here).
TEST AND INSPECTION SHEETS
The test process is a series of visual examinations, safety checks and test running of the (enter equipment here) . The following tests are to be conducted and supervised by (Your Company Here) with the aid of (Supplier Name Here).
CONTENTS
Pass/Fail Pre-FAT Suitability Inspection. Date of visit…………. 1,General Inspection Check List 2, Machine Safety and Functionality Inspection Check List 3, Machine Component Inspection Check List 4, Test Run 1 5, Test Run 2 6, Test Run 3 7, Test Run 4 -
Reference your document here
Written By:
Other references
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VALIDATION PLAN Document Title: (further description here)
Your Logo
Validation Approval (Delete as app.) Name
Responsible Author Quality and Compliance Manufacturing Regulatory
Signature
Date
Introduction Add an Introduction of the Validation Here
Brief System Description [Add a brief description of the system here] . All testing will be performed retrospectively, prospectively, concurrently (delete as appropriate), and all tests will be in accordance with your company name here“Validation Policy – Validation Master Plan XXXXXX
Scope [Enter a scope of the validation here]
Objectives The objective of this Validation are to ensure that the [Name Process Here] has been installed and operate retrospectively and is fit for use in accordance with cGMP and Health and Safety requirements.
Discussions
Detail any discussions that have taken place for the validation here and Identify activities and tasks that must be completed and approved prior to commencing any other tasks and activities. The following must be considered:
•The process must be listed on the Validation Timeline •The process must be deemed to require Validation and be documented on the Validation Plan. Add a timeline for the specific validation
Plan [List any actions that are planned for Validation]
Any deviation from the plan will be justified by a rationale and agreed by personnel who are involved in approving the validation.
Use the table overpage to populate tasks required
Reference your document here
Written By:
Other references
Revision: 01
Date
INSTALLATION, OPERATIONAL AND PERFORMANCE VALIDATION PROTOCOL FOR [NAME HERE] Document Title: (further description here)
Your Logo
Protocol Approval
Page 12 of 16
Print Name
Signature
Date
Print Name
Signature
Date
Production Engineering R&D Regulatory Affairs Quality Assurance
Executionl Approval
Production Engineering R&D Regulatory Affairs Quality Assurance
Introduction Add an Introduction of the Validation Here
Brief System Description and IOPQ Rationale [Describe the System and add a rationale for using the IOPQ approach] All systems shall be challenged in this protocol. Therefore it is imperative that checks are thoroughly documented according cGMP recommendations. All testing will be performed retrospectively, prospectively, concurrently (delete as appropriate), and all tests will be in accordance with Pharmi Med “Validation Policy – Validation Master Plan.
Scope This protocol covers the Installation, Operational and Performance Qualification (Combined) for the [Name Process Here]. The scope of this document is therefore limited to the testing for the equipment related to this and to assure that equipment is fit for use in accordance with cGMP. The protocol shall be reviewed and authorised by the stated personnel in the approval box prior to execution of IOPQ. The IOPQ execution shall be reviewed and approved prior to summary write up. Upon completion of the IOPQ, a final review will be done and signed off.
Objectives The objectives of this Installation, Operational and Performance Qualification (IOPQ) protocol is to ensure that the [ Name Process Here ] has been installed and operates retrospectively and is fit for use in accordance with cGMP and Health and Safety requirements.
Pre-requisites
Identify activities and tasks that must have been executed, been completed and approved prior to commencing the IOPQ activities. At a minimum, the following are pre-requisites.
•The process must be listed on the Validation Timeline. •The process must be deemed to require Validation and be documented on the Validation Plan. •The VP Deliverables checklist must be prepared. •The VMP document must be written and approved. •The ‘Pre-requisites to Validation Activities’ Stage Deliverables (identified on the VP Deliverables Checklist) must be completed and approved, or at least ongoing with scheduled target dates and the responsible person identified.
1
Noise Emissions
Using a noise meter hold close to ear level for 1 minute and monitor the noise levels to 80dB according to UK law noise at work 2005 regs
2
Workspace
Workspace around equipment installation should be at comfortable height and surroundings should be
3
Light Emission
Using a Lux Meter measure the light emission directly beneath the equipment and ensure that the lux levels are within reasonable standards
4
Risks of Corrosion
Ensure the material has no risk of corrosion, check safety data sheets and any material certs
YES / NO – If ……………………..
Acceptance criteria met
NO,
record
Completed By Sign
Date
Sign
Date
Verified By
Concession
number:
IQ/OQ/PQ (DELETE WHERE APPROPRIATE)
SUMMARY REPORT Summary Report of the (add Title of Protocol Here) Your Logo Add Site Here
Ref: Here
Rev: 1
Page No
Protocol Execution Approval (Delete as app.) Name
Responsible
Signature
Date
Signature
Date
Author Quality and Compliance Manufacturing Regulatory
Protocol Approval (Delete as appropriate) Name
Responsible Author Quality and Compliance Manufacturing Regulatory
Introduction Add an Introduction of the Validation Here
Brief System Description
All systems shall be challenged in this protocol. Therefore it is imperative that checks are thoroughly documented according cGMP recommendations. All testing will be performed retrospectively, prospectively, concurrently (delete as appropriate), and all tests will be in accordance with your company name here “Validation Policy – Validation Master Plan or Policy
Scope This protocol covers the Summary Report for the [Name Title Here]. The scope of this document is therefore limited to the testing for the equipment related to this and to assure that equipment is fit for use in accordance with cGMP. The report shall be reviewed and authorised by the stated personnel in the approval box prior to release of product/ use of equipment [delete where necessary].
Objectives The objectives of this Summary Report is to report findings throughout the protocol/s to ensure that the [Name Process Here] operates retrospectively, prospectively, concurrently [delete as appropriate] and is fit for use in accordance with cGMP and Health and Safety requirements.
Pre-requisites Summarise activities and tasks that must have been executed, been completed and approved. At a minimum, the following are pre-requisites:
The IQ/OQ/PQ protocol must be approved and executed and then reviewed and approved. All attachments in IQ/OQ/PQ must be complete and satisfactory, appended with references. All areas of IQ/OQ/PQ must be documented completely or written N/A (Not Applicable) where appropriate to GMP standards. All Information provided must be accurate and legible in Blue Ink Statistics (if provided) must be legible and explained) To supplement evidence of findings visuals such as photo’s or diagrams can be used throughout this summary.