VALIDATION PROTOCOL STANDARDS.
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
following method of construction must be used. The over-all protocol standards
are shown in the SOP’s 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;
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
- Each test must a have a result that is clear, unambiguous
- 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
Standard Protocol Inter-relationships.
Full Life Cycle Documentation Inter-relationships.
VALIDATION PROTOCOL STANDARDS.
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.
Plan (Issue 8) -- $89.00
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 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.
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
SOP for Spreadsheet
Creation. -- $125.00
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.
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.
SOP for cGMP Review
(Issue 3.) -- $89.00
cGMP Review is undertaken to ensure that a design and/or facility conforms to
the cGMP requirements and is fit for purpose. The requirement for Regulatory
Compliance will be established during the proposal preparation.
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
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
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
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
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
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
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
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