In the pharmaceutical industry, change management is something every company deals with on a daily basis. A change and deviation management system (CMS) is a central part of the overall quality management system for drug product manufacture and is often referred to as the pharmaceutical quality system.
Typical major GMP deficiencies related to CMS include: i) failure to evaluate FDA filing requirements; i.e., whether to file for a prior approval or changes being effected, or to report the change in the next annual report, ii) failure to file changes with the FDA, iii) failure to evaluate and / or justify whether equipment / system requalification is needed to support an equipment / system change, and whether process revalidation, stability studies, or equivalency studies are required to support a process and / or processing parameter change, iv) inadequate review and approval of the change by the quality control unit, and v) FDA expects the intimate involvement of the quality control unit in the change control review and approval process, and usually holds the quality control unit responsible for deficiencies regarding change control.
Regulatory Compliance Associates® Inc. can help you implement a CMS including the following as appropriate for the stage of the product lifecycle. Following is a representative, but not exclusive, list of reasons for change management: