VALIDATION 4U PROCESS



Validation 4u Introduction.

Before commencing a validation 4u task; an experimental runs must be planned.

These runs must establish the exact parameters that your validation run is  going to use and or attain in the final qualification runs of the system under qualification.

Most validation efforts require some degree of prospective experimentation to generate and establish validation support data.  This particular type of process validation 4u is normally carried out in connection with the introduction of a new drug or medical device and or their manufacturing processes.  The formalized process validation program should never be under taken unless and until the following operations and procedures have been completed satisfactorily:

  1. The facilities and equipment in which the process validation is to be conducted meet CGMP requirements (completion of DQ, IQ, OQ and PQ).
  2. The operators and supervising personnel who will be “running” the validation batch (es) have a comprehensive understanding of the process and its requirements.
  3. The design, selection, and optimization of the formula have been completed.
  4. The validation 4u trials using an agreed size of pilot-laboratory batches have been completed, in which the critical processing steps and process variables have been identified, and the provisional operational control limits for each critical test parameter have been provided
  5. Detailed technical information on the product and the manufacturing process have been provided, including documented evidence of product stability.
  6. Finally, at least one validation4u trial of a significantly larger production batch has been made and shows up; on scale-up, that there were no significant deviations from the expected performance of the process.

Plan to use Validation 4u Retrospectively.

The retrospective validation 4u option is chosen for established products whose manufacturing processes are considered stable and when on the basis of economic considerations alone and resource limitations, prospective validation programs cannot be justified.  

Prior to undertaking retrospective validation 4u, wherein the numerical in-process and/or end-product test data of historic production batches are subjected to statistical analysis, the equipment, facilities and subsystems used in connection with the manufacturing process must be qualified in conformance with CGMP requirements.  

The concept is also recognized in the FDA’s Guidelines on General Principles of Process Validation 4u Using either data-based computer systems [28,29] or manual methods, retrospective validation 4u may be conducted in the following manner:


  1. Gather the numerical data from the completed batch record and include assay values, end-product test results, and in-process data.
  2. Organize these data in a chronological sequence according to batch manufacturing data, using a spreadsheet format.
  3. Include data from at least the last 20–30 manufactured batches for analysis. If the number of batches is less than 20, then include all manufactured batches and commit to obtain the required number for analysis.
  4. Trim the data by eliminating test results from noncritical processing steps and delete all gratuitous numerical information.
  5. Subject the resultant data to statistical analysis and evaluation.
  6. Draw conclusions as to the state of control of the manufacturing pro- cess based on the analysis of retrospective validation 4u data.
  7. Issue a report of your findings (documented evidence).


VALIDATION 4U PROCESS.

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Equipment combined IQ/OQ/PQ Protocol.   $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 and associated standard operating procedures. It is interactive, easy to use and suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that all validation executables are catered for and that key aspects of the equipment adhere to approved design intentions and 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 and that there is sufficient documented process validation executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating  consistently and exactly as specified in the URS.

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12000002_VrrP_Equipment_iss-4. -- $298.00

This Validation 4U, Risk & Requirements Plan (VrrP) is one document designed specifically to replace three. The contents of the three original documents were completely revised and edited into a more compact and interactive format.  This new format will make a significant difference to the man hours required to produce and execute these process validation executables. There will also be a very noticeable reduction in the time required for the reviewing and approving tasks.  This new document titled the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/IQ/OQ/PQ into one document. 
This is an essential step forward for companies seeking to reduce validation 4U costs whilst remaining compliant with their Corporate Validation Manual.



12000006_4Q_Equip_iss-4. -- $298.00

4Q Equipment Validation 4U 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 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.



Design Qualification (Issue 5) -- $115.00

The Standard Operating Procedure attached to this generic design qualification protocol, will chapter by chapter, take you through the task of raising a fully detailed document. The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these design aspects allowing you to delete some you feel are not important to your equipment. It is an easy document to use and will ensure that you’re DQ’s and standard operating procedures, are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained along with compliance with your Corporate process Validation Executables  Manual requirements.

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Performance Qualification (P1Q) (Issue 5.) -- $89.00

The Performance Qualification is the last of the qualifying tests that equipment and processes are subjected to, prior to the actual first product run. It maybe that there are some steps in the process validation that can only be verified by actually running them (quick freezing and sublimation, to mention only two) or it sometimes is the fact that the product is a very expensive product, and can not be wasted. So no one wants to run the process with product, until they are completely certain there will be minimal waste and all relevant standard operating procedures are approved.

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