FDA has yet to issue a guidance document on change management. However, the U.S. Occupational Health and Safety Administration (OSHA) offers a useful model for pharma companies that can be applied broadly to managing change. This article will outline some useful best practices. This MOC (Management of Change) model, OSHA regulation 29 CFR 1910.119, Process Safety Management, requires that any changes that affect a process be managed. Among its requirements:
[COLOR=“blue”]Establishing written procedures and documentation for all changes
Documenting the purpose of each change
Reviewing each change for impact on safety, health, environment
Authorizing the implementation of the change
Reviewing additional risks introduced into the process
Setting a timetable for when temporary changes are to be removed or reevaluated
Updating process safety information
Revising or developing new operator and maintenance procedures as necessary
Training all employees and contractors who are affected by the change
Maintaining the configuration of the plant.[/color]
FDA regulations 21 CFR Part 211, 21 CFR Part 600, and 21 CFR Part 820 do not explicitly require change management. However, there is the implicit dictate to manage changes that affect a process, since they can inadvertently introduce new hazards or compromise safeguards that were built into the original design of the process.
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