A controlled document is one that is required by GMP standards or regulations or that otherwise falls under the scope of GMPs. Controlled documents include company program or policy documents that address GMP-related issues or requirements, GMP-related SOPs and records, etc.
When a manufacturer makes permanent changes or modifications to procedures or documentation to address regulatory changes or improvements or modifications in or with their own procedures or facilities, the changes should be reviewed, justified, documented, approved and implemented in a defined, systematic way. This system of documenting and approving permanent changes has become known in GMP parlance as “change control”. Temporary changes are considered deviations and should be addressed in conformity with appropriate documented procedures. Change control with its components of review, justification, documentation, approval and implementation allows us to evaluate the potential impact of change on regulatory guidance, previously approved procedures and documentation as well as on product quality and in some cases safety. Change control procedures must be formalized and identify what is and what isn’t covered by the procedure and how proposed changes will be identified or recommended, processed, reviewed and approved. While the cGMPs assign approval responsibility to the Quality Unit, other specialty groups may also be assigned or required to review procedures, e.g., engineers, chemists, computer experts, etc.