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VALIDATION PROTOCOL STANDARDS.



Document Management.

Validation Protocol standards must be used for writing
the Functional Test (FT) if it is to be a stand alone document that
can be executed and reviewed as part of the operational
qualification. The FT should first be written at the FAT stage. This
means that your vendor should write it, and so the vendor does in a
high percentage of instances. It is criminal that having spent
hundreds of hours authoring, developing and finally executing a detailed FAT at the factory,
the document is allowed to die and never be used again. For instance in a project Validation
Online was closely involved in, 87 people spent nearly one year in raising, approving and
executing the FAT for a Distributive Control System, while on site, 30 people spent over a
year writing the OQ qualification test scripts. The FAT reviewed and condensed would have
done a much better job, partly because it was written by staff, who had direct access to the
design staff who designed the DCS, but mainly because it was ready, and should have been
freely available from the vendor. The FAT and the FT, are the same as the re-qualifying tests
that are carried out on laboratory and process equipment. It becomes a little obvious that if
these documents were written to normal validation protocol standards, then, the one document
could be used for the testing section in documents like, the FAT, FT, qualification and re-
qualification of equipment.


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Validation Protocol Standards
The following method of construction must be used. The over-all protocol standards are
shown in the SOPs for the different protocols, here we are concerned about the testing
element alone. All testing must be detailed and pre-approved by a qualified person to ensure
the system under test has been adequately tested. Each test must comprise of;


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Validation Documentation Matrix
(Issue 6.) -- $29.00
This Matrix must sit along-side your
VMP or PVP and together with these
documents give a very concise overall
picture of your validation program. This
four part matrix allows you to list all the
equipment and systems that must be
qualified. Each entry is allocated a row
in the matrix. The row consists of
eleven headings, these may be edited
as required (but come with all the
standard documentation titles
inserted). In this matrix there is room to
enter the document number, prefixed
by, A to D. The document number gives
you the instant cross reference to all
the associated documents; the A to D
prefix shows the progress stage.
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Validation Plan (Issue 8) -- $89.00
This document follows our well-
developed method of using a generic
document and allowing the customer to
apply an attached detailed SOP to it,
turning the generic document quickly
into a first class company bespoke
CAPA Audit
GMP Gap Analysis
cGMP Validation
Predicate Rules
Risk Assessment
Staff Appraisal.
SOP for cGMP Rev
SOP Validation
Validation Matrix
Vendor Audit.
Hard Ware/Copy
Staff Evaluations.
Contracted Validate
Data Logger
Quality Manual
Humidity Calibration
Validation Manual
Technical Info:
EU Annex 11.
Free Vendor Audit
GAMP 5
Glossary
Hardware Validation
Measuring Instr's.
Med Devise Validate
FDA 21 CFR Part 11
Part 11 Update
21 CFR Part 211
21 CFR PART 820
Pharma Maint'ance
Protocol Standards
Validation Protocols.
Video News
Retro-Validation
Warning Letters
General Info:
Calculators For All
Conditions of Use
Corpus Clock
Customer List
Product for License
Computer Val Process
Point and Click
Free Downloads
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21 CFR Part 11.
Validation Academy
Machine Validation

Online Validation

Main Sub-headings in Test Script.
A Rationale; giving the reason and or object of the test.
A detailed Test Method.
A detailed Acceptance criteria; that the tests must produce.
A Test Result; confirming whether the test result, satisfied the acceptance criteria.
General details that must be adhered to.
The test result must be initialled (or signed) by the person executing the tests, on completion or
at each significant stage.
Each test must be designed to verify an element of the equipment functionality.
Each test must a have a result that is clear, unambiguous and known.
The test method must call up for the recording of the test result parameters. (no ticks or tick
boxes, no generalities).
Each test must be witnessed or the results must be reviewed by a competent person.
The overall test results must be approved by a competent person.

Standard Protocol Inter-relationships.


Full Life Cycle Documentation Inter-relationships.
document. This VP details and
integrates all validation activities and
procedures required for a small to
medium sized project, involving
production/facility/utility equipment
using electronic controls or monitoring.
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SOP for Equipment Validation (Issue 6.)
-- $22.00
This Standard Operating Procedure
(SOP) takes you through the validation
process for equipment, from the very
early first stages to the final closing
stage. It will ensure that your validation
is seamless, that the correct documents
are raised, approved, executed,
reviewed and accepted correctly. It
shows how to use validation tools such
as the very important matrix control
document and equally important risk
assessments. There are ever-increasing
demands on the Biotechnology and
Pharmaceutical industries to meet
increasing regulatory and legislative
requirements, whilst improving the
performance and efficiency of the
business. This SOP shows the way to
streamline your validation while still
being fully compliant. Easing and
smoothing the production and flow of
protocols, so decreasing costs and
delivering validation ahead of schedule.
It is essential material for the new
comer to validation and will direct you
flawlessly through all validation tasks.
For the company it is an essential SOP
to add to the library. For your
convenience it is written in word.
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Lab-Val-Package
Risk Based Validation
ValidationOnline Blog
GMP Interactive
Questionaire


VALIDATION PROTOCOL STANDARDS.

SOP for Spreadsheet Creation. --
$125.00
Why does something as simple as a
spreadsheet figure in so many
regulatory citations? Good question;
and at times a difficult one to answer.
When you ask a group of compliance
personnel the same question you will
be informed that Excel cannot be
validated because it does not seal the
original copy (of the spreadsheet),
allows the original to be modified and
has an audit trail that can be disabled.
All true, but none of these problems
interfere with your ability to validate
that the spreadsheet is fit for purpose.
They only preclude you from using the
spread sheet as a compliant repository
for any data that has to be store in
compliance with 21 CFR Part 11.
If the spreadsheet is signed off and
dated by the user, their supervisor and
QA, it becomes regulatory acceptable
data stored in hardcopy, and Part 11
does not apply.
After numerous request for this, we
have launched our brand new SOP for
Spreadsheet Creation to cover these
and other known target points that the
regulators consistently hone into as
soon as they find that spreadsheets are
being used. Use this Spreadsheet
Creation SOP to ensure that you create
spreadsheets that are validatable. Then
use our spreadsheet validation pack to
validate them.
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SOP for cGMP Review (Issue 3.) --
$89.00
The cGMP Review is undertaken to
ensure that a design and/or facility
conforms to the cGMP requirements
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Copyright 2005

and is fit for purpose. The requirement
for Regulatory Compliance will be
established during the proposal
preparation.
cGMP Reviews should normally take
place in accordance with the project
programme. The initial cGMP Review
should take place immediately after the
project initiation, to define the cGMP
Envelope and clarify the cGMP
requirements. Additional cGMP reviews
should be held towards the end of the
front end design and detailed design.
It is good housekeeping practice for
department heads to instigate periodic
cGMP walk rounds to analyse,
document and ascertain if every-day
wear and tear to the fabric of the
facility, is compromising the validated
status of the facility.
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SOP for a SOP (Issue 3.) -- $89.00
The ever sought after SOP for writing an
SOP. Adopting a standard format
throughout a company for the easy
authoring of SOP's is of immense
benefit to everyone that has to use
them. Our format follows our standard
company developed format of a generic
template prefixed by an SOP. Follow the
SOP and you quickly and simply
produce a sound compliant SOP
document. In this case the generic SOP
template is prefixed by a SOP.
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Compendium of Predicate Rules (Issue
3.) -- $85.00
The purpose of producing this
document in such a concise manner, is
to give a desk top reference document
that can be used by authors, engineers
and quality staff. It can be used in
meetings, during general conversation
and during telephone conversations.
You first check the CPR to see what
rules apply, then check out the rules in
depth. You can always be sure that your
documents are referenced to the
correct GMP requirement.
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21 CFR Part 11, Verification (Issue 3.) --
$26.00
This test script has been designed to
verify whether a system or a specific
piece of equipment conforms with the
requirements detailed in Part11. This
Test Script is not in the standard
Operational Qualification (OQ), and is
only available here as a direct
download.
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Corporate Manual Quality
The FDA has raised the bar. The
rationale for change, the approach it
has taken and the progress achieved
are not as good as some think. In
September 2003, The Wall Street
Journal published an article informing
all that pharmaceutical manufacturing
techniques lag behind those of potato-
chip and laundry-soap makers. The
same article correlated the rise in
recalls with quality problems and noted
that despite fines in excess of US$500
million for manufacturing failures,
acceptable levels of quality were not
being achieved.
Since then, the FDA, and the industry
have been actively, working together to
shape the new quality requirements
and standards. Compliance now
requires a quality systems approach
starting with quality by design in
development and ending with scientific
process control in manufacturing. So
today, products are more complex; cash
is scarcer; and quality requirements
require more fundamental
understanding. Pharmaceutical
companies need to take action on each
of these issues in a comprehensive
manner.
The Corporate Quality Manual (CQM)is
only available on DVD and is normally
dispatched within two working days.

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Definitive Validation Manual (Issue 5.)
-- $1,160.00
This definitive 1000 + page Definitive
Validation Manual arrives with you in
DVD format, this enables you at any
time to download protocol or test-scrip
documents and quickly edit them into
company bespoke documents. In fact
there are over $3,500.00 worth of
superb documents that form
attachments to the DVM manual, which
can be instantly copied. Once copied,
the unique document interactive
editing, allows you to produce high
quality bespoke company documents
(weeks of work in a few hours). The cost
of the Definitive Validation Manual, will
be recouped in the first few weeks of
use. It will then go on to show a massive
return on your original investment.
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