Regulatory Requirements for Ongoing/Continued Process Verification

With the coming into effect of the FDA Process Validation Guideline 2011 and the revision of Annex 15 (2015), the process lifecycle has become state of the art in the field of validation. What does this mean in practice?

FDA Warning Letters provide a good insight into this. In addition to a complete lack of process validation, the FDA frequently mentions deficiencies in stage 3 of the validation lifecycle, the Ongoing/Continued Process Verification.

The FDA has described this quite clearly in a recent Warning Letter. Among other things, the FDA demands control and monitoring of every manufacturing process. This explicitly includes an attentive monitoring of intra- and inter-batch variations in order to keep the process in a controlled state. The sources of the variability should be based on data and determined with scientific methods. This includes the "suitability" of the equipment, as well as controls of the starting materials. Consequently, the FDA also criticizes the lack of qualification of the equipment and premises at this manufacturer.

For further information please also read the complete FDA Warning Letter to RLC Labs Inc.