One of the most basic controls in pharmaceutical operations is the change control process. Going beyond just basic documentation, the true change control system will provide for evaluation, approval and regulatory filing of all changes – equipment, processes, facility, etc.
This 17-page guideline was written to provide an outline of what is required to become compliant with change control. The contents are as follows:
FDA Expectations and Check Points Four Reporting Categories
Audit your System Changes in Limbo
Procedures reflecting Practice Emergencies
Global Company Changes Implementing Changes
Streamline the Process What is in a Change Control SOP?
As a bonus, we are also including an electronic copy of the Change Control SOP – a $60 value free.
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