This combined IQ OQ PQ
protocol was specifically designed to be used for stand-alone equipment. It has been collated from the three individual templates and incorporates approximately thirty mandatory inspections and or tests that are considered essential in the verification that the equipment under qualification has been properly installed, operates and performs in a manner that satisfies all the appropriate requirements as detailed in the relevant User Requirements Specification (URS),
cGMP’s and your company practices and procedure rulings.
>All companies carryout routine calendar based qualification and re-qualification functional testing of stand-alone
laboratory type equipment.Unfortunately most of this testing is documented in a manner that is not compatible with basic FDA, WHO & EU validation protocol standards.If a little time was spent on revamping these test documents standards, (changing the template would only have to be done once) a format could be used that would enable all such testing to be included in any validation requirement.
Since regulators already accept the concept that unnecessary retesting should be avoided whenever possible. It follows that since all other tests in our protocols are fully written up, if the routine functional testing was of the right format then a recently executed routine or commissioning test could be reviewed and commented on in any validation protocols,as an alternative to repeating all the associated testing. This would result in the time line and cost of validation for this equipment being greatly reduced.
All our three part combined IQ OQ PQ
protocols are written to a common standard with the layout, introduction and table of contents being very similar.
>While all the test and inspection stages are purposely targeted at the validation requirements of the specific item under qualification.
The IQ section contains all the standard inspections and tests that you would include in a stand-alone IQ for the same equipment. The OQ section in a
similar manner contains all the standard tests and inspections that are usually included in a stand-alone OQ protocol and the PQ follows the same pattern.
All three sections contain spare test
script pages; that can easily be edited to suit any specific additional tests that may be required.
So why not ask about validation time line savings made in using these three part protocols?
One introduction to be edited.One rationale to be edited - Test scripts all written up for you - One document to be circulated for review - One document to be edited - one document to circulate for reviewing.
Only one document to be managed and
maintained through from conception to execution and through change control and on to archived.
Consider 10 items requiring validation that means it could be just 10 protocols as opposed to 30 to write, review, edit and approve. Make no mistake; reviewing and approving documents is always the task that is least planned for and subsequently often a serious bottle neck in achieving time line requirements.
Most editing is interactive, i.e. entering the basic data once (Company name/equipment details, etc.) immediately inserts the entered data throughout the whole document.
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Master Plan (Issue 7) -- $115.00
This document follows our proven practice of supplying a interactive generic document with an automatic method of populating it. Once populated, all you need to do is follow the prompts in the attached SOP. They will take you through the completion process section, by section. At the end of this process your generic document has progressed into a detailed, referenced, bespoke company document. The document follows our three level URS system that ensures functionality traceability from the URS to the various testing protocols and is a great document to author and use. This document interfaces with our Validation Risk
Assessment (VRA), Validation Project Plan (VP), User
Requirements Specification (URS), giving a seamless flow from your VMP through
the VP - IQ - OQ - PQ, while integrating flawlessly with the URS - DQ -
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
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 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
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.