The FDA and Change Control

There are two brief notes in the Code of Federal Regulations on the topic of “change control”, as follows:

  • 211.100 for Written procedures; deviations. (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.”
  • 211.160 General requirements. (a) “The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. The requirements in this subpart shall be followed and shall be documented at the time of performance. Any deviation from the written specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms shall be recorded and justified.

Now that we’ve covered the regulations concerning change control in the United States, we’ll turn our attention to the specifics of compliance with European Union change control regulations.