SBU Pharma Liquid Training 2002

Validation Phases

By Alain Kupferman

Validation Phases
Robert Bosch GmbH reserves all rights even in the event of industrial rights. We reserve all rights of disposal such as copying and passing on third parties.

SBU Pharma Liquid Training Validation Phases Qualification / Validation Activities

Design Qualification Installation Qualification Operation Qualification Performance Qualification

Product Validation / Process Validation There are no FDA approved machines FDA does not approve or prohibit specific equipment and materials

Validation Phases

Robert Bosch GmbH reserves all rights even in the event of industrial rights. We reserve all rights of disposal such as copying and passing on third parties.

SBU Pharma Liquid Training Validation Phases

Life Cycle Equipment

DQ IQ OQ

Change Control Qual. Report Training GMP Operation Val. Report Training

PQ PV

Validation Phases

Robert Bosch GmbH reserves all rights even in the event of industrial rights. We reserve all rights of disposal such as copying and passing on third parties.

SBU Pharma Liquid Training Validation Phases Design Qualification

Definition of critical pharmaceutical parameters necessary for a good, reproducible function of the equipment adapted to the needs of the product to be manufactured in line with current regulations Description Role in process Materials Output / Range / Sizes Controls (I,C,R,A)*

*(Indicate, Control, Record, Alarm)

Validation Phases

Robert Bosch GmbH reserves all rights even in the event of industrial rights. We reserve all rights of disposal such as copying and passing on third parties.

SBU Pharma Liquid Training Validation Phases Installation Qualification

I.Q. is a stage in the process validation exercise normally executed by the engineering group. The installation of equipment, piping, services and instrumentation is undertaken and checked to engineering drawings (Piping & Instrument Drawings, P.&I.D.) and plant functional specifications developed during the project planning stage. I.Q. will involve the identification of all system elements, service conduits and gauges and a documented record that all installed equipment satisfies the planned requirements. Identification and documenting of maintenance requirements for each installed item and the collection and collation of supplier operating and working instructions, maintenance and cleaning requirements should form the minimum documentation and records for a satisfactory Installation Qualification.

Validation Phases

Robert Bosch GmbH reserves all rights even in the event of industrial rights. We reserve all rights of disposal such as copying and passing on third parties.

SBU Pharma Liquid Training Validation Phases Performance of formal IQ

IQ requires a formal and systematic check of the installed equipment against equipment supplier's specifications. As-built check Check against PID All equipment should be identified with serial number, label, tag. Formal check using IQ test document

Validation Phases

Robert Bosch GmbH reserves all rights even in the event of industrial rights. We reserve all rights of disposal such as copying and passing on third parties.

SBU Pharma Liquid Training Validation Phases Installation Qualification IQ

Issue overall IQ plan Identify key documents and specifications Develop IQ protocols Use change control Identify calibration requirements Consider pre-delivery check (FAT) Perform formal IQ Detail preventative maintenance Issue IQ report

Validation Phases

Robert Bosch GmbH reserves all rights even in the event of industrial rights. We reserve all rights of disposal such as copying and passing on third parties.

SBU Pharma Liquid Training Validation Phases Development of IQ, OQ, PQ, ... protocols
formal document specifies tests and testing activities

Use change control

Company system Control updates to specifications

Validation Phases

Robert Bosch GmbH reserves all rights even in the event of industrial rights. We reserve all rights of disposal such as copying and passing on third parties.

SBU Pharma Liquid Training Validation Phases Identify key documents and specifications
P & I Ds Engineering Drawings Layout Drawings Equipment Data Sheets and Specifications Valves Indicators Pumps Filters Equipment Certificates Equipment Labels

Validation Phases

Robert Bosch GmbH reserves all rights even in the event of industrial rights. We reserve all rights of disposal such as copying and passing on third parties.

SBU Pharma Liquid Training Validation Phases Identify calibration requirements

Confirm calibration of calibrating equipment with reference to national standard Calibrate measuring devices used in OQ where no confirmation of calibration exists Calibrate measuring devices related to installed equipment Identify calibration requirements for measuring devices for future use of equipment

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Validation Phases

Robert Bosch GmbH reserves all rights even in the event of industrial rights. We reserve all rights of disposal such as copying and passing on third parties.

SBU Pharma Liquid Training Validation Phases Operation Qualification

O.Q. is an exercise oriented to the engineering function, generally referred to as commissioning. Critical variable (parameter) studies of the operation of the equipment and systems will define the critical characteristics for operation of the system or sub-system. All testing equipment should be identified and calibrated before use. Test methods should be authorised. implemented and resulting data collected and evaluated. An effective change control procedure should be operational and encompass the whole project from the pre-planning stage through to the final acceptance of the process validation exercise

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Validation Phases

Robert Bosch GmbH reserves all rights even in the event of industrial rights. We reserve all rights of disposal such as copying and passing on third parties.

SBU Pharma Liquid Training Validation Phases Operation Qualification OQ

issue OQ plan identify critical features, limits, modes design the OQ tests and issue OQ protocols check installation, calibration and commissioning are complete perform OQ tests, possibly in simulation mode issue OQ report release the equipment for use

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Validation Phases

Robert Bosch GmbH reserves all rights even in the event of industrial rights. We reserve all rights of disposal such as copying and passing on third parties.

SBU Pharma Liquid Training Validation Phases Consider pre-delivery check

For large or complicated pieces of equipment a manufacturer may elect to carry out a pre-delivery check at the supplier's assembly plant. (FAT) The pre-delivery check is not a substitute for IQ

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Validation Phases

Robert Bosch GmbH reserves all rights even in the event of industrial rights. We reserve all rights of disposal such as copying and passing on third parties.

SBU Pharma Liquid Training Validation Phases Which points are critical to the Auditor ?
Design Process Qualification / Computer Validation Maintenance Planning and Implementation Calibration Change Control Deviation Control Requalification Operation of equipment Data Integrity Training programs

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Validation Phases

Robert Bosch GmbH reserves all rights even in the event of industrial rights. We reserve all rights of disposal such as copying and passing on third parties.