Follow
Previous validation is based on historical and test data from previously manufactured batches. This includes compliance with trend analysis and the extent to which the process is within the permissible limits of the process parameters.
Using computer-based data or manual methods. The following procedure is to perform validation (pre-validation).
=>> Collect data from previously completed batches.
=>> Sort all data by sequence, eg, batch production and expiry date.
=>> Ten to twenty-five batches or more are used for this purpose, preferably processed no more than 12 months apart and reviewed together.
=>> Batches rejected during routine quality control are not included in this review.
