QUALIFICATION

Presented by
AKHIL M B
Dept of Pharmaceutical Analysis

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 QUALIFICATION
• Action of proving and documenting that equipment or
ancillary systems are properly installed, work correctly, and
actually lead to the expected results.
• Qualification is part of validation, but the individual
qualification steps alone do not constitute process validation.

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USER REQUIREMENT SPECIFICATION
• User Requirements Specifications are written early in the validation
process, typically before the system is created. They are written by the
system owner and end-users, with input from Quality Assurance.
• Done when an user proposal for either a change to existing equipment
or the introduction of new equipment.
• Proposer produce a list detailing all the attributes and features
essential to efficacy and safety of the proposal.
• The URS is originated by the end user extrapolating requirements
directly from the production process.
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 Contd…

• An URS package will include all aspects of purchasing, installing and

operating the specified system.

• There are also some indirect requirements such as documentation,

manpower, training and test equipment that must be fully researched,
investigated and specified.

• The URS must be written in a format that allows each of these

requirement to be verified as being ‘fully satisfied’ or not.

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 THE URS SHOULD INCLUDE:
o Introduction

– including the scope of the system, key objectives for the project, and the
applicable regulatory concerns.
o Program Requirements
– the functions and workflow that the system must be able to perform.
o Data Requirements
– the type of information that a system must be able to process.

o Life Cycle Requirements

– including how the system will be maintain and users trained.

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URS LEVEL-1 DOCUMENT

• Once URS is documented, agreed, submitted for approval, they form basic URS level 1
document.

URS LEVEL-2 DOCUMENT

• The engineer commence the preliminary design to establish exactly what function are
need for each of the item specified in USR, then they listed.

• Once the URS function is documented and approved it forms URS level-2 document.

URS LEVEL-3 DOCUMENT

• Developing URS is a standard practise is strictly regulated industries in the creation of

quality softwares.

• It contains all the traceability which is deemed mandatory for software assessed to be
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critical to product quality in pharmaceutical regulated industries.
 BENEFITS OF URS
 Serves as a reference against which off-the-shelf commercial products
are selected, evaluated in detail, and any enhancements are defined.

 Reduces the total system effort and costs, since careful review of the
document should reveal omissions, misunderstandings and/or
inconsistencies in the specification and this means that they can be
corrected easily before you purchase the system.

 Provides the input to user acceptance test specifications and/or

qualification of the system.
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 DESIGN QUALIFICATION
• A design qualification protocol is used at stage where a design has been
developed from the VMP, URS, cGMP and other Health and safety guidelines.
• It is reviewed and documented by competent person to ensure that the
designed equipment , if built will satisfy all the detailed specific
requirements, as contained in VP and URS.
• It is the documented verification that the proposed design of the facilities,
systems and equipment is suitable for the intended purpose.
• DQ should be performed when new equipment is being purchased, or when
existing equipment is being used for a new application.
• DQ serves as the precursor to defining the equipment Installation
Qualification (IQ) and OQ protocols. 8
CONTD..

• The purpose is to ensure that all the requirements for the final systems
have been clearly defined at the start.
• The design qualification is the only document that is going to confirm
that the design will work.
• It must be authored and executed by suitably qualified person who are
knowledgeable enough to challenge the proposed design and it’s
performance.
• If you have no such persons in your staff , you must contract such
qualified persons.
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 SCOPE OF DESIGN QUALIFICATION

The design qualification verifies that

• The design will meet URS requirement

• The utility service required are available and validated.

• The required support documentation is specified.

• The design complies with the VMP.

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CONTD..

• The system will be calibratable.

• The operation staff training requirements.

• The system will be maintainable.

• The system will operate in a manner safe to both product and staff.

• The system conforms to all applicable national standard and

guidelines.

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 FACTORY ACCEPTANCE TESTING
• FAT is executed at the vendor test facility and done by client or client
representative.
• It is an inspection that include both static and dynamic exhaustive
testing of system or major system components to support the
qualification of equipment or system.
• The test must be verify that all functionality detailed in the URS is
embodied and perform as specified.
• It is written by manufacturer and executed by client.
• It is the first stage of system acceptance testing.
• The supplies should ensure that the system can pass predetermined
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tests.
CONTD…
• The testing should be witnessed by the manufacture prior to agreement for
the system to be delivered to the site.
• The supplier may be requested to produce proper records of the testing, if
not witnessed by the manufacture.
• The extend of FA is maximised to reduce the risk of problems arising during
final acceptance test carried on site and during system qualification.
• Must be written to fully challenge the function specification derived from URS.
• Regulation compliance protocol documentation standard must be used for
writing the FAT and vendor should write it.

• Summary - It is the partial commissioning and qualification of

equipment and/or systems prior to their shipment from the 13

fabricator’s site.
 SITE ACCEPTANCE TESTING
• The SAT is related to FAT and also entails inspection and dynamic
testing of systems or major system components to support the
qualification of equipment.
• It is written by client and verifies that the installed functionality of the
equipment meets or exceeds the operational requirements as
specified in URS.
• Executed on completion of all commissioning tasks but prior to start of
installation qualification.
• SAT result should be analysed and compared to FAT results.
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CONTD…

• Drawing record of actual installation is marked up and submitted to

pharmaceutical manufacture for review and approval.

• Calibration of instrumentation will be performed over the complete

instrument loop.

• During each loop all data must be documented, loop calibration sheet
are submitted to manufacturer for review, approval and record.

• SAT provide opportunity to identify and correct any problem due to

shipping, utility hook up, hardware assembly and field installation.
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SITE ACCEPTANCE RESPONSABILITIES

• Component unpacking, inspection and storage.

• Computer installation and power up.

• Instrument installation.

• Instrument calibration.

• Installation report.

• System operating and maintenance manual.

• Handover to pharmaceutical manufacture. 16

 SAT IN IT’S BASIC FORM INCLUDES
• Installation check-up
• Power up
• Diagnostic check up
• Commissioning of process
• Safety related operation
• Controls
• Sequencing
• Interlocks
• Alarm
• Reports 17
 REFERENCE

• Nash. A. Robert and Wachter H. Alfred “Pharmaceutical Process

Validation”an international 3rd edition volume 129 revised and
expended

• Manohar A Portdar “Current manufacturing practices” for

pharmaceuticals

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THANK YOU

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