21 CFR 211.100 - Written Procedures; Deviations

Overview:

21 CFR 211.100 mandates written procedures for production and process control to ensure drug products meet identity, strength, quality, and purity standards. 

These procedures must be reviewed, approved, and followed by relevant personnel, with any deviations documented and justified. The regulation ensures that all production processes are consistent and compliant with required standards.

(a) 

There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit.

(b) 

Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.