Elements and Performance Criteria

Design qualification
Demonstrates and documents compliance with GMP design requirements
Design requirements of facilities and equipment must meet those outlined in Australian Code of Good Manufacturing Practice for Medicinal Products, Chapter 3


Installation qualification
Installation qualification includes but is not limited to:
checking of equipment, piping, instrumentation and services installation checked against current engineering drawings and specifications
P&IDs (piping and instrumentation diagrams), operating manuals and other supplier information relating to operation and maintenance
calibration requirements
cleaning and sanitation inspection requirements
safety issues
environmental issues


Operational qualification
Operational qualification includes but is not limited to:
tests of processes, systems and equipment to confirm that functioning meets agreed criteria within operating conditions
calibration plans
preventative maintenance plans
operating, cleaning and sanitation operating procedures (SOPs)
training programs and schedules
recording requirements


Performance qualification
Performance qualification may include but is not limited to:
tests - using production materials, qualified substitutes or simulated product - that have been developed from knowledge of the process, facilities, systems or equipment
tests to include a condition or set of conditions encompassing upper and lower operating limits


Validation requirements
Validation requirements include but are not limited to:
process validation
packaging validation
cleaning validation
calibration validation
test method validation
validation of computerised systems
revalidation of in-use processes


Validation protocol
A validation protocol includes but is not limited to:
a short description of the process
summary of the critical step/s being investigated
list of equipment/facilities to be used (including measuring/monitoring equipment) together with its calibration status
finished product specifications for release
list of analytical methods, as appropriate
proposed in-process controls with acceptance criteria
additional testing to be carried out, with acceptance criteria and analytical validation, as appropriate
sampling plan
methods for recording and evaluating results
roles and responsibilities
proposed timetable


Validation documentation
Documentation may include but is not limited to:
validation master plan
protocols
reports
operating procedures and work instructions
OHS and environmental requirements
manufacturers' specifications

Overview of assessment
Assessment may occur in a real or simulated pharmaceutical or complementary medicine manufacturing workplace where the assessment environment provides access to workplace documentation relating to qualification and validation processes that are typical of commercial manufacturing businesses and meet the requirements of the Therapeutic Goods Act. It will also provide a range of commercial production/packaging equipment and activities typically used in a commercial manufacturing environment.
Qualification processes may be simulated to allow a walk through of the process.

Resources for assessment
Copies of the relevant Act, regulations, codes and guides.
Workplace documentation including procedures relating to qualification and validation.
Real or simulated workplace context.

Overlap with related units

This unit could be assessed concurrently with other units relating to problem solving and process improvement. This may include:

FDFPHGMP4A Facilitate and monitor Good Manufacturing Practice
FDFPHFCC4A Facilitate contamination control
FDFPHCC4A Participate in change control procedures
FDFPHRWD4A Prepare and review workplace documentation to support GMP
MCMT450A Undertake process capability improvements
FDFOPTSPC2A Apply principles of statistical process control

Method of assessment
Assessment of this unit would typically involve responding to 'what if' scenarios, answering questions and conducting workplace projects.

Critical aspects for assessment and evidence required to demonstrate competency in this unit

Evidence of participation in a team responsible for validation processes. This includes providing evidence developed by the candidate to:

Review the qualification and validation protocols to assess implications for a work area and related departments/functions.
Participate in qualification procedures - Design Qualification (DQ); Installation Qualification (IQ), Operational Qualification (OQ), and/or Performance Qualification (PQ). For example, this could include conducting trials in the work area as part of performance qualification in a work area. The assessment activity requires use and/or development of checklists and tools in required formats to carry out qualification as part of a project team. It also includes monitoring and reporting on outcomes.

Communicating ideas and information
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Collecting analysing and organising information
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Planning and organising activities
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Working with others and in teams
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Using mathematical ideas and techniques
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Solving problems
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Using technology
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