CRED Managing Variations Effectively

Chapter B – Post approval change management protocol An approved CMP can be modified before implementation through a Type II/IB variation

Example 1: (Biological mAb)

• Type II B.II.g.2: To introduce a PACMP for the new manufacturing site 1 for pre-filled syringes (PFS) • Type IB B.II.g.5.b): To register Manufacturing Site 1 • Type IB B.II.g.4.b): To adapt the PACMP for introduction of Manufacturing site 2 for PFS • Type IB B.II.g.5.b): To register Manufacturing Site 2

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