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Kultur Dokumente
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.
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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.
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Page 3 of 15
Equipment Validation
Doc No.
Issue: 06
Revision History
Revision No.
Date
Name
Description
Equipment Validation
Doc No.
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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
1.3
Golden Rules...........................................................................................7
The Practicalities.............................................................................................8
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
2.9
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1.1
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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 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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Diagram 1. FLCV.
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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.
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
2.2
Raise
Documentation
Matrix
(10000002)
chart
as
described
in
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.
Page 11 of 15
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Issue: 06
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
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
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.
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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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
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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
The URS top level functionality is further broken down into sub-functions in the Design
Specification (DS).
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 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.
Page 14 of 15
Equipment Validation
Doc No.
2.9
Raise
Issue: 06
Installation
Qualification
online.net/installation-qualification.html
as
or
described
purchase
in
and
http://www.validationdownload
one
from
an
Operational
Qualification
online.net/operational-qualification.html,
as
or
described
purchase
in
and
http://www.validationdownload
one
from
an
Performance
Qualification
online.net/performance-qualification.html,
as
or
described
purchase
in
and
http://www.validationdownload
one
from
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