Document Number -

STANDARD OPERATING PROCEDURE

FOR

EQUIPMENT VALIDATION

This Standard Operating Procedure (SOP) relates to an item of equipment that is the property of llllllllll.. The information contained within this
SOP is propriety information. and is the property of lllllllllll. This information may not be copied or disclosed in whole or in part by any third
party / parties without the prior written consent of the company.

APPROVALS

Engineering Approvers Signature:

Your signature indicates that the documentation and information contained herein complies with the
applicable regulatory, corporate, divisional/departmental requirements and current Good manufacturing
practices.
Name:

Signature:

Title:

Dept:

Date:

QC Approvers Signature:
Your signature indicates that the documentation and information contained herein complies with the
applicable regulatory, corporate, divisional/departmental requirements and current Good manufacturing
practices.
Name:

Signature:

Title:

Dept:

Date:

Approval of Production Manager:

Your signature indicates that this document has been prepared with your knowledge, that you agree with the
purpose and scope of this document, that the document has been reviewed by the appropriate persons and
that you understand the areas of responsibility for your department during execution of this validation plan.
Name:

Signature:

Title:

Dept:

Date:

Standard Operating Procedure

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Equipment Validation

Doc No.

Issue: 06

Revision History

Revision No.

Date

Name

Description

Standard Operating Procedure

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Equipment Validation

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Issue: 06

Table of Contents
Table of Contents.........................................................................................................4
1.0

2.0

Practical Validation.........................................................................................5
1.1

Introduction.............................................................................................5

1.2

Validation Document Sequence..............................................................5

1.3

Golden Rules...........................................................................................7

The Practicalities.............................................................................................8
2.1

Task 2. Validation Plan...........................................................................9

2.2

Task 3. Introduction to Matrix...............................................................9

2.3

Task 4. Matrix Population.....................................................................11

2.4

Task 5. User Requirement Specification (Sections 1) (URS)..............11

2.5

Task 6. User Requirement Specification (approval), (URS)................11

2.6

Task 7. Design Qualification (DQ)......................................................12

2.7

Task 8. User Requirement Specification (Sections 2 ) (URS).............13

2.8

Task 9. User Requirement Specification (Sections 3.) (URS).............13

2.9

Task 10. Installation Qualification......................................................13

2.10 Task 11. Operational Qualification......................................................14

2.11 Task 12. Performance Qualification.....................................................14

Standard Operating Procedure

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Equipment Validation

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1.0
1.1

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Issue: 06

Practical Validation
Introduction.

A simple and direct approach to the validation task. This document will take you by the
hand and lead you through the sequence of events that are required to be put in place, and
executed, to enable validation to be satisfactorily completed.
All validation relates to a regulated product either directly or indirectly.
Direct validation is the verification of the recipe (in a medical device, the design).
Verification that the said ingredients (design) processed (manufactured) in accordance with
the recipe (design specification) will consistently produce the final product to the efficacy
that is specified.
Indirect validation is the validation of production and process equipment. Verification
that the said equipment, consistently produces the product (or product part) within defined
specifications.

1.2

Validation Document Sequence

Validation starts at the Validation Master Plan (VMP) stage and flows through a series of
documents that define the scope and tasks required to successfully qualify the system /
equipment. The VMP dictates the actions that all persons involved in validation projects
must comply with. The Validation Plan (VP) contains the actions required for individual
validation projects. The typical document stream is;
VP - URS - DQ - VRA - IQ - OQ - P1Q - P2Q.

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The VMP is not a mandatory requirement, but is always asked for in regulatory reviews.
(URS - DQ - VRA) are mandated and self explanatory.
With the Installation Qualification (IQ), Operational Qualification (OQ), Performance
Qualification (P1Q) and Process Qualification (P2Q), there is a degree of flexibility as
regards to the content of these documents. Although the document title clearly defines its
scope, it is possible and permissible to arrange some elements of testing in the most
expedient sequence. I.e. do you wait for power 'on' to do IQ, perhaps? Perhaps not? It can
be argued that when power is on you are operating the equipment (so power on testing
should be in the OQ). Can IQ therefore be completed prior to power up?
It can, and often is, hotly debated, whether all the testing carried out in the FAT, SAT and
commissioning stages, must be repeated in the validation stage. (i.e. are you going to repeat
some of the testing four times?) This is where the VP becomes a vital document. Senior
persons with a good understanding of the overall project, decide the content and scope of
each of these documents, obviously within cGMP constraints. They can derive a unique
sequence of validation tasks for a number of reasons (to reduce repetitive testing - to ease
access problems and on), providing that their reasoning is documented in the VP and fully
justified.

The VP is then used by the protocol writers as the official mandate for protocol
content.

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Golden Rules
These rules should always be complied with.

1)

Never assume that the regulations dont apply to your situation because your company is small, or
has a small budget, or doesnt have the expertise available.

2)

Always do something to respond to each of the regulatory requirements. You can always debate the
adequacy of what youve done, but you can never defend doing nothing.
Always ensure that all (and that means everything) equipment (instruments , valves, pipes, tanks etc.)
are labeled with plant numbers and the plant numbers given, are correct to installation drawings,
Always stick to known and accepted practices and procedures, do not experiment or challenge
conventional methods (unless you have the backing of your MD and or client). Contentious ideas can
and often do lead to regulatory clashes a thing to be avoided at all costs.
Always ensure before commencing validation that Change Control, a Calibration Regime and
Planned Preventative Maintenance, systems are in place.
Always document your response to each regulatory requirement. In the eyes of an inspector or
auditor, if you didnt document it, you didnt do it.
The software validation requirements that apply to software used in manufacturing and process
control are regulated by 21 CFR 820.70 and 21 CFR 820.30. All software, from machine-tool
embedded software, to materials-planning software, to simple spreadsheets, is subject to these
regulations, in all branches of the industry (biotechnical, pharmaceutical and medical device).

3)
4)

5)
6)
7)

8)

9)

10)

Always take the time to understand why the regulators might feel each requirement is important for
device / recipe quality and respond to that requirement appropriately. It does little to improve or
assure the quality of a device / recipe when you take shortcuts in the quality process just to satisfy
regulatory requirements
Never document that your company has followed a process required by regulation when you really
have not. Inspectors are trained to find evidence of this kind of activity. Furthermore, this deceptive
activity does nothing to add value or quality to your device / recipe.
When in doubt about how to comply with regulations, do the right thing. The most defensible position
always will be that which does the most to assure the safety and effectiveness of the device / recipe.

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Issue: 06

2.0 The Practicalities.

You have a new product and you are tasked with the validation of all the equipment,
facilities and utilities, being put into place to manufacture this product.
Task 1.

Obtain all available equipment / system information.

Diagram 1. FLCV.

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Issue: 06

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 Validation Plan (VP) is used to manage

validation projects that are smaller in size and have easily defined boundaries. Raise the
appropriate Validation (Master) Plan (VMP/VP) as described in http://www.validationonline.net/validation-master-plan.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 circulation comments and submit for approval.
Issue document for project management use.

2.2
Raise

Task 3. Introduction to Matrix.

a Validation

Documentation

Matrix

(10000002)

chart

as

described

in

http://www.validation-online.net/validation-documentation-matrix.html or purchase and

download one from http://quality.validation-online.net 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 is does not, or can not, then list individual equipment. For each listing raise
individual User Requirement Specifications.

Either author one in accordance with

http://www.validation-online.net/user-requirements-specification.html
download one from http://quality.validation-online.net/

Diagram 2. Matrix

or purchase and

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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.

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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 http://www.validation-online.net/validationrisk-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 RAs 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 must be subjected to, to ensure it is
correctly validated, and whether the system has to conform to 21 CFR Part11.

2.4

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 http://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.

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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
teams responsibility to ensure that each individual invitation to tender, has the appropriate
URS attached.
Diagram 4. Document Relationships.

2.6

Task 7. Design Qualification (DQ).

Ensure all preceding documents are signed off and approved.

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Issue: 06

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 http://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.

2.7

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.

2.8

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.

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Doc No.

2.9
Raise

Issue: 06

Task 10. Installation Qualification.

an

Installation

Qualification

online.net/installation-qualification.html

as
or

described
purchase

in
and

http://www.validationdownload

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.

2.10 Task 11. Operational Qualification.

Raise

an

Operational

Qualification

online.net/operational-qualification.html,

as
or

described
purchase

in
and

http://www.validationdownload

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.

2.11 Task 12. Performance Qualification.

Raise

an

Performance

Qualification

online.net/performance-qualification.html,

as
or

described
purchase

in
and

http://www.validationdownload

one

from

Standard Operating Procedure

Title

Equipment Validation

Doc No.

Page 15 of 15
Issue: 06

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.