Legacy equipment considerations

Presented by Marc Fini

21 May, 2013

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Tablet Press - Legacy

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Tablet Press - Modern

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Equipment validation

A lot of equipment on the market is ‘legacy’ type equipment.

• This equipment is not necessarily novel and extensive time for improvements to be incorporated into the most recent design and build are valid considerations

• The manufacturer of the equipment has likely considered market feedback and continually improved the equipment with each new version released

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Equipment validation

Standard equipment compared with customised systems.

• Low levels of customisation are common to standard equipment

• In a validation context this may translate into more available knowledge with manufacturer and a piece of equipment

Detailed supplier knowledge

Market feedback and experience

Significantly improved risk management process

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Equipment validation

Customised systems may require a more extensive validation effort because they are unique and may not have been tested over time in the market place

Standard equipment compared with customised systems:

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Equipment validation

Commissioning, qualification and validation are the final parts of a long process

Quality by Design aspects may have been incorporated, to some extent, into the design and build of the machine

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Equipment validation

• Good Manufacturing Practice and Good Engineering Practice both aim for a common outcome.

• Quality should be achieved by good design.

• Criticality assessments are especially important. Consider the following criticality assessment criteria:

• Patient Safety

• Product Quality

• The business impact of the product and processes

• All of these items must be traceable back to the URS

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Equipment validation - suppliers

Construction, URS evaluation

Configuration, Test functions

Factory Acceptance Testing

Delivery

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Equipment validation - user

Commissioning and Qualification, Installation, Site Acceptance Testing (SAT), FAT, Training

Start production

• Ongoing operation

• Maintenance Life Plan and spare parts

• Training

Preventative and Reactive Maintenance

Change Management

Periodic Review

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Equipment validation

User and supplier cooperation is fundamental to success. Consider the following requirements:

Specifications Design Manufacture and routine operations

Qualification and

validation

Control strategy

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Equipment validation A case study

Packaging machinery validation:

• Older piece of machinery, may have been refurbished

• Exclude the printing system

• This is not a comprehensive validation of a new system but a consideration of legacy equipment and the associated validation

Jonathan Davey et al, ISPE Pharmaceutical Engineering, Volume 27, Number 3

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Equipment validation

What has an impact on patient safety and product quality?

Identify what is GxP critical within the machine

Avoid testing the software code, instead focus on functionality testing

Test the identified,

critical functionality

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The Basic ‘V’ Model

.

System Build

related to

related to

related to User

Requirements Specification

Performance Qualification

Functional Specification

Installation Qualification

Design Specification

Risk Assessment

Risk Assessment

Risk Assessment

Design Review

Operational Qualification

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Equipment validation

HMI

Label rollers,

unwinders

Speed,

tensioners,

splice

detection

Production

data,

counters

Reject

station

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Equipment validation

Key User Requirements for the labelling machine may include:

Splice detection

Run out detection

Web tensions

Speed controls

Reject functionality

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Equipment validation

• Reverse engineer the process and identify documentation gaps.

• Use the machine as the starting point.

This process will rely heavily on the knowledge and expertise of the people using the machine.

• This includes maintenance engineers and production technicians.

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Equipment validation

How to perform a GxP criticality assessment:

• Document clear descriptions and boundaries

of operation

• Detail the interfaces, so which machines are immediately next to this one?

1. Divide the machine into sub assemblies

• Determine the impact this has on product quality

• Reference these impacts to the URS

• Establish a team of people to contribute; engineers, experienced operators, QA...

2. Detail the functionality of the machine sub assembly

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Equipment validation

• If this fails the impact is...

3. Determine the failure mode impact

• Functionality testing

• SOPs and administrative controls

• Detection of failure mechanisms

• Maintenance and calibration requirements

4. Determine the controls needed

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Equipment validation

A more detailed risk assessment could further assist with developing an appropriate strategy.

For example:

1. Product critical, sterility

2. Product efficacy

3. Aesthetics

4. Efficiency

5. No criticality

Reducing validation effort

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Control strategy considerations

• For process variable components

• Validation is required

• Consider the label reel system; speed, pressure are variables

• Testing the variable across a range of parameters to establish an operational criteria

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Control strategy considerations

Functionality testing should provide a capability of a particular components reliable operation range.

What would be the control strategy for the following?

• Splice detector

• Reject gates

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Control strategy considerations

Calibration

• To support and verify operating ranges over time

Operational instruction

• Line clearances

• Cleaning and appropriate reagents

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Control strategy considerations

Maintenance

• Maintain desired functionality

• Spare parts catalogue

• Maintenance Life Plan

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Revalidation considerations

Revalidation may not be required.

• Consider a review with evidence

• The need to perform product quality reviews (Section 1.4 of the PIC/S GMP code) may be apparent and there are 12 items that need to be considered in the product quality review effort.

• These include failed batches, significant changes and deviations

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Revalidation considerations

The data that you are basing revalidation decisions on must be reliable.

How is the data collected? Is the data analysed for

its significance?

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Revalidation considerations

Troublesome performance

Targeted requalification/revalidation of the components causing issues

Significant change/major deviations

A revalidation/requalification may be required to ensure performance aspects can be fulfilled

Good performance

Review with evidence to verify the consistency of the machine

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Control strategy considerations

Before we establish and effective control strategy, we need to build data and knowledge regarding the routine, repeatable performance ranges for the following sensitive components:

Complex sensors Speed controllers

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Summary

Legacy equipment and the knowledge within the organisation are critical

Criticality assessment is performed to identify components with a GxP critical function based on a set criteria

The validation effort is scalable based on the criticality assessment

The control strategy considerations should not be foreign to what you currently do, but need to verify the adequacy of the control strategies