Elements and Performance Criteria

RANGE STATEMENT
The range statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Bold italicised wording, if used in the performance criteria, is detailed below. Essential operating conditions that may be present with training and assessment (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) may also be included.
Design qualification
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
piping and instrumentation diagrams (P&IDs), 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
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
re-validation 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
occupational health and safety (OHS) and environmental requirements
manufacturers' specifications

EVIDENCE GUIDE
The Evidence Guide provides advice on assessment and must be read in conjunction with the performance criteria, required skills and knowledge, range statement and the Assessment Guidelines for the Training Package.

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.

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, installation qualification, operational qualification, and/or performance qualification
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.

Context of and specific resources for assessment
Assessors must be satisfied that the person can consistently perform the unit as a whole, including all elements, performance criteria, and required skills and knowledge. A holistic approach should be taken to the assessment.
Assessment of this unit would typically involve responding to 'what if' scenarios, answering questions and conducting workplace projects
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.

Method of assessment
This unit could be assessed concurrently with other units relating to problem solving and process improvement. Examples could be:
FDFOP2015A Apply principles of statistical process control
FDFPH4001A Prepare and review workplace documentation to support Good Manufacturing Practice
FDFPH4002A Facilitate and monitor Good Manufacturing Practice
FDFPH4003A Facilitate contamination control
FDFPH4004A Participate in change control procedures
MSACMT450A Undertake process capability improvements.

Guidance information for assessment
To ensure consistency in one's performance, competency should be demonstrated on more than one occasion over a period of time in order to cover a variety of circumstances, cases and responsibilities, and where possible, over a number of assessment activities.