IQ-OQ-PQ



Combined IQ-OQ-PQ Protocols.

IQ-OQ-PQ website page. Subsidiary chapter 1, image represents symbolic production equipment used to produce pharmaceutical products by;
www.validation-online.net.

This combination DQ-IQ-OQ-PQ design of protocol template was designed by Validation Online, in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It  was specifically  designed to make it the preferred choice for Process and Laboratory stand alone equipment. It is interactive, easy to use and suitable for all mixes of equipment with and without software.
The Installation Qualification (IQ) (section 1 of combination DQ-IQ-OQ-PQ) establishes documented verification that key aspects of the equipment adhere to approved design intentions and that the recommendations of the manufacturer have been suitably considered. The Operational Qualification (OQ) (section 2 of combination DQ-IQ-OQ-PQ)  establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary evidence to demonstrate this. The Performance Qualification (PQ) (section 3 of combination DQ-IQ-OQ-PQ) gives documented verification that the equipment performance in its normal operating environment is consistently exactly as specified in the User Requirements Specification (URS).


Introduction to the DQ-IQ-OQ-PQ Protocols.

IQ-OQ-PQ webpage. Subsidiary Chapter 2. Symbolic image demonstrates visibility of customer comments to production operators of www.validation-online.net.

The DQ-IQ-OQ-PQ protocol template contains over seventeen fully detailed test scripts along with the methodology for twenty more compliance tests and inspections. It has been collated from the three individual DQ-IQ-OQ-PQ templates and incorporates sufficient inspections and test stages to ensure 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 online 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 Test Specification (FTS) was of the right format then a recently executed routine or commissioning test could be reviewed and commented on in any validation online protocols,  as an alternative to repeating all the DQ-IQ-OQ-PQ 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, WHO & EU requirements for protocol testing formats that should be used for DQ-IQ-OQ-PQ protocol wording.


DQ-IQ-OQ-PQ Protocols Evolution.

IQ-OQ-PQ webpage. Subsidiary image Chapter 3, this image presentation clearly defines this medical device as being life supporting.
www.validation-online.net

All of our three part combined DQ-IQ-OQ-PQ protocol templates 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 online requirements of the specific item under qualification.

The IQ section of the combined DQ-IQ-OQ-PQ protocol contains all the standard inspections and tests that you would include in a stand-alone Installation Qualification Protocol for the same equipment. The Operational Qualification section of the combined DQ-IQ-OQ-PQ in a similar manner contains all the standard tests and inspections that are usually included in a stand-alone OQ protocol and the Performance Qualification section follows the same pattern.

All three DQ-IQ-OQ-PQ protocol 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 online time-line savings made in using these three part protocols ?  Which are still held as three separate tasks (for compliance purposes); but are published as one document (for cost effectiveness).  I.E. One introduction to be edited.  One rationale to be edited - Test scripts all written up for you - One document to be circulated for peer review - One document  to be approved and printed. Only one document to be managed and maintained through from conception to execution and through change control and on into archive.

The case for the combined DQ-IQ-OQ-PQ is very compelling.

Consider 10 items requiring validation that means it could be just ten DQ-IQ-OQ-PQ protocols as opposed to thirty 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.

Note:-
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.


The IQ-OQ-PQ Template Design.

IQ-OQ-PQ Subsidiary image Chapter 3 presents the importance of isolation and sterility to pharmaceutical products.
www.validation-online.net

This Combined DQ-IQ–OQ-PQ protocol is a really easy and attractive document to use. It is prefaced by a 10 page SOP, which enables you to follow the SOP instructions and progressively (page by page) convert this fully detailed template into a superb Combined DQ-IQ-OQ-PQ protocol.

This protocol is targeted at equipment and is suitable for all equipment from the laboratory to the process line. All standard verification's are already included in the protocol format and all test scripts are fully documented and referenced.

Validation Online documents should never be confused with the routine document templates available on the internet. These templates are mainly little more than a list of chapter headings. Where as, Validation Online documents are of a unique interactive design which has been developed over the last ten years. Ten years during which regulatory compliant documentation has been successfully supplied to over sixty countries.

Our unique combined DQ-IQ-OQ-PQ design was developed by a team of pharmaceutical consultants working across the pharmaceutical, medical device and bio-technical industries. These consultants covered all the validation disciplines and collectively pondered long and hard to come up with a design that would be acceptable to all users and highly cost effective for companies.

Now this new combined DQ-IQ-OQ-PQ protocol brings a refreshingly simple and attractive approach for the industry professional, enabling them to raise professional quality validation online protocols in a very efficient and cost effective manner.


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Combo DQ-IQ-OQ-PQ
4Q-2 Equip (Issue-4)

$298.00

4Q Equipment Validation Protocol (4Q-Equip) has been designed specifically to replace four standard protocols.   By taking the contents of the four protocol and carefully weaving them into one notably easy to use protocol, we have made a significant advance in the task of streamlining process validation  Online executables documentation and associated standard operating procedures, by reducing protocol numbers by close to 75%.  The new bang up to date 4Q protocol replaces the DQ, IQ, OQ & PQ and now compliments our equally new VrrP Protocol.  By integrating the old style DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in the authoring, reviewing, updating and approving tasks.
For everyone's convenience, the Corporate Validation 4U Manual template is written in written in word. 


$159.00 Combined IQ-OQ-PQ Computer (Issue-4) -- $159.00

This combination IQ-OQ-PQ  protocol has been produced in response to several hundred Validation Online reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment. It is interactive, easy to use and suitable for all mixes of equipment with and without software.



Combined IQ/OQ/PQ for Spreadsheets. (issue-2)
$159.00

This combination protocol has been specifically designed to verify that all aspects of your spreadsheet conform to best practice and that the spreadsheet layout ensures consistent and accurate use and results. The tests and inspections normally authored in separate protocols have been assembled in one protocol which is divided into three sections. This protocol enables you to verify that your developed spreadsheet application is GMP compliant, thus avoiding 483s and warning letters. You can now validate your application with minimal documentation. Equipment Validation Protocol, validation protocol template,



Combined IQ/OQ/PQ Protocol for Quality Steam (Issue-4)
$185.00

This is a very detailed and comprehensively scripted protocol. All the test scripts required for IQ/OQ/PQ execution are in place ready for editing to represent your installation exactly. Tests scripts are very detailed and all calculations are broken down into simple stages. Illustrated equipment hook up diagrams and sequential instructions further ensure that this testing is easily within the skills of the average technician. All sterilization tasks using steam attract the attention of the regulators. There are often serious problems that inhibit or reduce the sterilizing efficacy of steam that remain obscure to the operator and only become apparent to the end user. The power of steam to sterilize is very closely linked to the characteristics of that steam. Routine steam quality testing must be carried out to ensure that your sterilization processes are never compromised. Annual testing of steam automatically attracts auditor attention. Steam quality must be re-verified when ever any changes or disturbances affect a qualified quality steam system. Equipment Validation Protocol, validation protocol template,



Combined Climate Controlled Zone IQ/OQ/PQ (Issue 10)
$159.00

This combination protocol has been produced in response to several hundred reader suggestions we received in our - Suggestions Section -. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment. It is interactive, easy to use and suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that key aspects of the equipment adhere to approved design intentions and that the recommendations of the manufacturer have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently and precisely as specified in the User Requirement Specifications (URS). validation protocol template.



Combined IQ-OQ-PQ Software (Issue-3)
$159.00

This combination protocol has been produced in response to several hundred reader suggestions we received. It has been carefully designed to make it the preferred choice for the qualification of embedded and stand-alone software used in the pharmaceutical, medical devices and bio-technical industries. It is interactive, easy to use and meticulously detailed.
The IQ section establishes documented verification that key aspects of the software adhere to approved design intentions and that the recommendations of the regulators have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary evidence to demonstrate this. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently and exactly as specified in the User Requirements Specifications (URS) Equipment Validation Protocol, validation protocol template.



Combined IQ/OQ/PQ Quality Steam (Issue-2)
$565.00

Here is the chance to bring steam quality testing in house. No one can over emphasis the importance of steam quality. Right now in the medical and pharmaceutical industries are three of the biggest law suites in the whole history of the industry; and all three revolve around adultered steam sanitization processes.
There are often serious problems that inhibit or reduce the sterilizing efficacy of steam that remain obscure to the operator and only become apparent to the end user.
The power of steam to sterilize is very closely linked to the characteristics of that steam. Routine steam quality testing must be carried out to ensure that your sterilization processes are never compromised. Annual testing of steam automatically attracts auditor attention. Steam quality must be re-verified when ever any changes or disturbances affect a qualified quality steam system, validation protocol template.