EQUIPMENT VALIDATION.


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Definition: Equipment Validation.

Equipment is "validated" when there is documented evidence verifying that the design, installation, operation and performance have been certified as being equal to: or better than, the specified requirements documented in the User Requirements specification (URS).  This validated status must be maintained by a purpose designed Planned Preventative Maintenance Program (21 CFR Part 211.58 refers).      


Introduction to Equipment Certification.

Compliant equipment validation can be quite simple to achieve providing the procurement stage has been thoroughly investigated and concisely documented in accordance with a company approved process (SOP).   The procurement process normally starts with the production of a documented requirement or group of requirements (URS). For new builds this must be incorporated into the originating validation or project plan (VP).

For existing facilities this should take the form of a CHANGE REQUEST (CR).  As soon as management has agreed to proceed with the CR, approval should be issued to produce a VP.  This plan must be all encompassing.  It must give assurance that all aspects of the proposed CR have been studied and the CR impact on existing facilities, utilities, product and personnel have been defined and the appropriate corrective or support actions planned for.  A fully detailed User Requirements Specification (URS) can now be authored reviewed and published.  Since developing the URS may raise problems that could not be anticipated when the VP was raised; there must now be a VP review to ensure all aspects of the final approved URS are authorized and planned for.    

With an approved VP in place, a start can be made in authoring, reviewing and publishing the qualification protocols that are required to verify that all the requirements documented in the URS and all applicable cGMP requirements are complied with.  These are:

Where vendor developed Functional Specifications (FS) and or Design Specification (DS), are available they should be reviewed and referenced in the VP.  Where these documents are not available a DS or FS may have to be retrospectively developed.  The Design Qualification (DQ) must be used to verify that this FS or DS (if proceeded with) will deliver a system compliant with all requirements in the URS and the applicable cGMP rules and regulations. The execution of this DQ must verify that the proposed design will;

  • Perform as specified in the URS.
  • Conform to all mandated cGMP requirements.
  • Operate in a manner safe to the product, and the operations staff. 

The installation of each validatable system must be subjected to, and satisfy, a pre-approved Installation Qualification (IQ) protocol.  When the requirements of the IQ have been satisfied, all aspects of the operational capabilities of each system must be fully challenged and verified by the execution of a pre-approved Operational Qualification (OQ) protocol.  As soon as the executed IQ and OQ protocols having been reviewed and approved, a pre-approved Performance Qualification (P1Q) protocol or Process Qualification (P2Q) (this requirement will be documented in the VP) must be issued for execution.  The execution of this PQ must verify that the system performance requirements, as specified in the URS have been achieved, and that the system operates in a manner safe to the product and production personnel.



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All validation relates to a regulated product either directly or indirectly.

Direct equipment validation; refers to the validation of all equipment that is actually used in the manufacture of the the product (mixers/ovens/autoclaves etc.)

Indirect equipment validation; refers to the validation of all equipment that must be in place to support the direct equipment and or is required to deliver any specific environmental conditions specified in a process in use. (process air/water/HVAC/isolation etc).


Equipment Validation Implementation and Progression.

You have a new product and you are tasked with the equipment validation for the entire project.  Along with the facilities and utilities, being put into place to manufacture this product.

Task 1. Obtain all available equipment / system information.


Diagram 1.  FLCV.

This schematic depicts the inter-relationship between the various documents required for successful Equipment Validation.

Task 2.  Validation Plan

Validation Master Plan (VMP) gives an overall depiction of the company facilities, along with the management structure, and details of how cGMP is, or is to be, integrated with all company activities.   On the other hand the Equipment Validation Plan (VP) is used to manage equipment validation projects that are smaller in size and have easily defined boundaries. Raise the appropriate Validation (Master) Plan (VMP/VP) as described in https://www.validation-online.net/validation-master-plan.html or purchase and download one from "http://quality.validation-online.net/validation-documentation.html"  Complete all requirements and circulate draft copy of document for peer review.

Incorporate all circulation comments and submit for approval.

Issue document for project management use.


Task 3.  Introduction to Matrix.

Raise a Validation Documentation Matrix (10000002) chart as described in https://www.validation-online.net/validation-documentation-matrix.html or purchase and download one from "http://quality.validation-online.net/validation-documentation.html" and in the ‘description’ column, list all equipment that requires to be reviewed for validation assessment.

As far as possible where equipment operates as a system, it should be listed as a system.  Where it does not, or can not, then list individual equipment.  For each listing raise individual User Requirement Specifications.  Either author one in accordance with https://www.validation-online.net/user-requirements-specification.html or purchase and download one from OUR DOCUMENT SHOP

This graphic depicts an Equipment Validation Matrix sheet.

Right click in each cell of the spreadsheet, and open a Comments page. Insert into the comments page;
Person responsible for the document:
Date started:
Date first review:
Date final review:
Date issued:
Date executed:
Date execution reviewed & accepted.
The above data would normally be monitored and controlled from a planning schedule (such as Microsoft Project as shown on Diagram 3), however it is important to have this matrix in place as the master record of all project details.



Diagram 3. Plan.

This graphic depicts a Validation plan layout as required for successful Equipment Validation.

Task 4.  Matrix Population.

As items are added to the matrix, a unique number is allocated to each one, in Column 1.  This is the equipment validation number, individual protocols are subsequently identified by adding the document acronym to the end of the unique number.  This way all validation documents for an item have the same identifying number.  Progressively subject each item listed in the matrix, to the questions in the Validation Risk Assessment (VRA), which should either be authored in accordance with https://www.validation-online.net/validation-risk-assessment.html  or purchased and downloaded from http://quality.validation-online.net/

As each piece of equipment completes the VRA and is given a risk rating, and an assessment for part 11 compliance, enter these ratings into column seven of the matrix, in the row allocated for the equipment.  Format, (risk rating)(Y or N for part 11 compliance).

Note:

Risk Assessment (RA) in the pharmaceutical / biotech / medical device validation industry, is often misunderstood.  In regulated industries RA’s are used for a many different purposes.   In our case we are only considering the use of an RA to justify the depth and scope of our validation requirement.  As such the VRA has to simply ascertain; what scope of validation this system / equipment qualification must be subjected to, to ensure it is correctly validated, and whether the system has to conform to 21 CFR Part11.

Task 5. User Requirement Specification (Sections 1)  (URS).

For each system/item listed in the matrix raise a user requirements specification as (URS) as described in https://www.validation-online.net/user-requirements-specification.html or purchase and download one from http://quality.validation-online.net.   Register each URS by giving it a unique number and entering that number into the matrix column.

Circulate the registered URS templates to the individual equipment owners as specified in the project VP/VMP.  Request owners complete section one of URS.

Task 6. User Requirement Specification (approval),  (URS).

On complete of Section One requirements, the URS must be reviewed and approved.   The approved URS must then be forwarded to the procurement team.  It is the procurement team’s responsibility to ensure that each individual invitation to tender, has the appropriate URS attached.

Schematic sketch of the equipment validation documentation requirements.

Task 7.  Design Qualification (DQ).

Ensure all preceding documents are signed off and approved.

When all vendor (and in house) design proposals have been submitted, (received from in, or out of house sources) the accepted design, must be subjected to a DQ, to validate it is fit for purpose.  A Design Qualification (DQ) protocol must be raised

in accordance with https://www.validation-online.net/design-qualification.html or purchase and download one from http://quality.validation-online.net .

The approved DQ must be executed to validate that the design is robust and has been subjected to sufficient proof of concept testing, to establish that if proceeded with, it will satisfy the requirements listed in the URS. 

Task 8.  User Requirement Specification (Sections 2 ) (URS).

The URS top level functionality is further broken down into sub-functions in the Design Specification (DS).  The vendor must therefore complete Section 2, of the URS, documenting the relationship between the URS functionality and the actual design functionality.   This is required to enable compliance with the requirement for maintaining the traceabilty from URS to software code, as further described in Task 9.

Task 9.  User Requirement Specification (Sections 3.) (URS).

Task 9 only applies where the equipment / system uses software.  The original Section 1, of the URS completed by the end user, detailed the top level functionality required.  Section two completed by the vendor detailed the sub-functions required to enable section 1 functions.  Section 3, completed by the code writers must detail the line or groups of lines required for each function and sub-function.

Task 10.   Installation Qualification.

Raise an Installation Qualification as described in https://www.validation-online.net/installation-qualification.html or purchase and download one from http://quality.validation-online.net/  Complete all requirements and circulates draft copy of document for peer review.

Incorporate all review comments and submit for approval.

Ensure all preceding documents are signed off and approved, prior to executing this document.

Issue document for execution.

Review executed document.

Produce summary report.

Task 11.  Operational Qualification.

Raise an Operational Qualification as described in https://www.validation-online.net/operational-qualification.html, or purchase and download one from http://quality.validation-online.net/  Complete all requirements and circulates draft copy of document for peer review.

Incorporate all review comments and submit for approval.

Ensure all preceding documents are signed off and approved, prior to executing this document.

Issue document for execution.

Review executed document.

Produce summary report.

Task 12.  Performance Qualification.

Raise an Performance Qualification as described in https://www.validation-online.net/performance-qualification.html, or purchase and download one from http://quality.validation-online.net/.  Complete all requirements and circulates draft copy of document for peer review.

Incorporate all review comments and submit for approval.

Ensure all preceding documents are signed off and approved, prior to executing this document.

Issue document for execution.

Review executed document.

Produce summary report.


EQUIPMENT VALIDATION.


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