Friday, July 21, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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6.1.9 Retrospective validation

Retrospective validation is only acceptable for well-established processes and will be inappropriate where there have been recent changes in the composition of the tissues or cells, operating procedures or equipment.

Validation of such processes should be based on historical data. The steps involved require the preparation of a specific protocol and the reporting of the results of the data review, leading to a conclusion and a recommendation.

The source of data for this validation should include, but not be limited to batch processing and packaging records, process control charts, maintenance log books, records of personnel changes, process capability studies, finished product data, including trend cards and storage stability results.

Batches selected for retrospective validation should be representative of all batches made during the review period, including any batches that failed to meet specifications, and should be sufficient in number to demonstrate process consistency. Additional testing of retained samples may be needed to obtain the necessary amount or type of data to retrospectively validate the process.

For retrospective validation, generally data from ten to thirty consecutive batches should be examined to assess process consistency, but fewer batches may be examined if justified.

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