Commissioning and Qualification

Presented by Marc Fini

21 May, 2013

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Commissioning and Qualification

Performing qualification to avoid non compliance will lead you to failure.

Perform qualification to minimise the impact of risks on:

Product safety

Patient safety

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Commissioning and Qualification

What is commissioning?

Engineering activity

Planned, documented and managed process

Start up and handover of ‘systems’

Safety and functionality

DQ and stakeholder expectations

Find and fix problems

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Commissioning and Qualification

What is qualification?

Science based

IQ, OQ, PQ

Documented verification that all aspects of a ‘system’ that can affect product quality, perform as intended

Confirm the critical functionality of direct impact systems

Targeted approach

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Commissioning and Qualification

• Approved specifications, construction, materials and installation

IQ

• Operation as intended through all anticipated ranges

OQ

• Perform as intended, meeting pre-determines acceptance criteria

PQ

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Commissioning and Qualification

Focus qualification on what’s important.

Quality by Design (QbD)

Manufacturing processes and formulation

Product quality

Process control strategies

Risk based regulatory scrutiny

Patient safety

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Commissioning and Qualification

Risk based approach

• Design strategy

• Commissioning and Qualification strategy

• Automation and Maintenance strategies

Tools

• Commissioning and Qualification strategy

• Impact assessments

• Technology transfer

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Commissioning and Qualification

Maintaining the validated state requires:

Operational analyses

Change management

Feedback loop

Process performance

reviews

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Commissioning and Qualification

The basis for qualification:

User Requirement Specification

System impact assessments

Heavier initial workload

Focussed approach

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Impact Assessment

Components

Syste

ms

Critical Non-Critical

Direct Impact

Indirect / No Impact

Not P

ossib

le

Commissioning and

Qualification Commissioning only

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Commissioning and Qualification

Costs

• Technology transfer

• URS

• Risk assessments

• Impact assessments

• DQ

Benefits

• Better engineered system

• Streamlined qualification

• Priorities

• Targeted approach

• Compliance

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Commissioning and Qualification

There are components of commissioning and qualification that require careful management.

The methodology for change and deviation management needs to be determined before validation begins.

The commissioning and qualification effort needs:

• Engineering evaluation

• QA evaluation

• Project structure and strategies

• Tracking of implementation

Slide 13 © PharmOut 2013