Written production and process control procedures are followed in the execution of the various production and process control functions, and are documented at the time of performance. Any deviation from the written procedures must be recorded and justified. Deviation should be reviewed by the quality unit to ensure no deleterious effect and that the drug products have the identity, strength, quality, safety, and purity they purport or are represented to possess. When deviations occur, it may necessitate the use of the nonconformance (NCR) and/or the out-of-specification (OOS) process as appropriate.

Another consideration when production and process control functions are birthed or changed is notification and training. It is required that approved changes be communicated to the appropriate personnel in a timely manner, and, where appropriate, the personnel are trained on the changes.

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