VALIDATE A PROCESS


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Plan to Prospectively Validate a Process.

When you intend to prospectively validate a process; an experimental plan called the validation process protocol is executed (following completion of all equipment, utility and facility cGMP qualification) before the process is put into commercial use.  Most validation efforts require some degree of prospective experimentation to generate validation support data.  This particular type of process validation 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 qualification 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 qualification 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 Retrospectively Validate a Process.

The retrospective validation 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, 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 Using either data-based computer systems [28,29] or manual methods, retrospective validation 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 data.
  7. Issue a report of your findings (documented evidence).


VALIDATE A PROCESS.

SOP for Spreadsheet Creation.

Why 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.
After numerous requests 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 Spreadsheet Creation. -- $125.00

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SOP Equipment Validation.

The SOP for Computer Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.


Purchase your copy now at Special Price of $22.00.

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Validation Risk Assessment (Issue11.) -- $125.00

The Risk and Part 11 Validation Risk Assessment (VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.
This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).

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