Module 9 2024

03/09/2024

CPP Assignment Process

1. Failure mode and Effects Analysis (FMEA) risk assessment used to assess PPs based on risk, severity, occurrence and detectability Information is from process knowledge and development experience

5. Update FMEA based on PC outcome and complete risk assessment to inform final control strategy

4. Design and execute Process Characterisation studies

3. Identify medium and high risk CPPs

2. Identify CPPs and non-CPPs

The Organisation for Professionals in Regulatory Affairs

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Example CPP Assignment Process

Detectability

Severity Score Assignment

Severity x Probability

1

2

3

4

Description

80 56 40 28 24 20 14 12 10

80 56 40 28 24 20 14 12 10

160 112

240 168 120

320 224 160 112

Predicted to cause severe impact to quality (Product out of specifications, no Expert Statement possible) Predicted to cause significant impact on quality (Failure to meet specifications, no Stability data, Expert Statement possible) Predicted to cause minor impact on quality (Failure to meet specifications, Stability data available) Predicted to have no/minor impact on quality of the product (Quality within specifications)

80 56 48 40 28 24 20 16 14 12

10Extreme

84 72 60 42 36 30 24 21 18 12

96 80 56 48 40 32 28 24 16 12

7High

3Moderate

1 Low

If Severity >5 = CPP

8 7 6 4 3 2 1

8 7 6 4 3 2 1

Occurance Score Assignment

Description

8Regular failures 4Repeated failures 2Occasional failures 1Unlikely Failures

Expected to happen regularly

8 6 4 2

Expected to happen in low frequency Expected to happen infrequently

9 6 3

Unlikely to happen

8 4

Detectability Score Assignment

Description

Risk Priority Number (RPN) used to identify process risks (SxOxD) RPN Class Description

Failure very likely to be overlooked, hence not detected (no technical solution, no manual control)

4Normally not detected

Actions

Failure may be overseen (manual control, spot checks)

3 Likely not detected

May be non-CPP or pCPPs that are well controlled/detectable

Failure will normally be detected (manual control, routine work with statistical control)

<50

Low

None

2Regularly detected

50-100 Medium

pCPPs that may/may not require characterisation

Requires process characterisation

Failure can and will be detected in all cases (monitoring, technical solution available)

1Always detected

>100 High

pCPPs that require characterisation

Process characterisation

The Organisation for Professionals in Regulatory Affairs

20

10