|
IQ OQ PQ PROTOCOLS.
Introduction the requirement..This combined IQ OQ PQ
protocol was specifically designed to be used for stand-alone equipment. This combination protocol comprises of
three protocols which collectively have approximately thirty inspections or
tests that must be executed to verify that the equipment under qualification is
used, 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 requalification 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 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. Click here to view the FDA requirements for protocol
testing formats and wording. Welcome to the home of IQ OQ PQ validation protocols. Please click on the appropriate link below for details of the iq oq pq protocol template you require. User Requirements Specification. Or the associated tools: Perhaps you do not want a template. If you require a protocol bespoke to your requirement and ready to use, please click below: Bespoke Ready to Use Protocols. If the document you want is not listed here please look in our document store:
The Bio-Med industries have documented regulations which are often
subjected to numerous interpretations.
Some of theses interpretations prove to be erroneous, some however, go on
to become acceptable practice and can eventually lead to the actual rules being
re-written or even abolished. Validation Online has added a section to this website to encourage
its reader to share or seek advice about these interpretations and of course
problems in general. We will give
considerable editorial time to this section and we would ask all our readers to
participate and share their expertise.
A problem shared - Is often – A problem
solved. A brilliant idea is totally wasted if not
shared. If you wish to get advice on a problem, or share a unique process
or idea, please click on the appropriate line above. If neither of these appeal to you
perhaps you would be kind enough to click on the text in the boxes below and
assist us by answering these questions.
As answers and data are collected they will be published in a searchable
section of our website. |
Procedural Documentation
Validation 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 - VRA.
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.
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 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 word.