Assessor Resource

FDFPH2009A
Dispense pharmaceutical raw materials

Assessment tool

Version 1.0
Issue Date: June 2024


This unit applies to production operators working in the pharmaceutical sector. This person would typically work within defined Good Manufacturing Practice (GMP) programs and procedures. This unit typically targets the production worker responsible for applying basic operating principles to the operation and monitoring of measuring and dispensing equipment.

When batch or product changeover procedures are part of this work process, the procedures should be used to customise the application of this unit. Where more detailed changeovers are carried out, FDFOP2011A Conduct routine maintenance, should be considered.

This unit of competency covers the skills and knowledge required to weigh, measure and label non-bulk ingredients to meet batch requirements.

You may want to include more information here about the target group and the purpose of the assessments (eg formative, summative, recognition)

Employability Skills

This unit contains employability skills.



Evidence Required

List the assessment methods to be used and the context and resources required for assessment. Copy and paste the relevant sections from the evidence guide below and then re-write these in plain English.

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 must be carried out in a manner that recognises the cultural and literacy requirements of the assessee and is appropriate to the work performed. Competence in this unit must be achieved in accordance with food safety standards and regulations.

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

Evidence of ability to:

weigh and measure materials to achieve required quantities

start, operate, monitor and adjust dispensing equipment to achieve required quality outcomes

take corrective action in response to typical faults and inconsistencies

complete workplace records as required

apply safe work practices and identify OHS hazards and controls

apply food safety procedures to work practices.

Context of and specific resources for assessment

Assessment must occur in a real or simulated workplace where assessee has access to:

personal protective clothing and equipment

work procedures, including advice on safe work practices, GMP, SOPs and environmental requirements

information on equipment capacity and operating parameters

dispensing schedule, batch instructions

specifications, control points and processing parameters

dispensing process and related equipment and services

materials required for the dispensing process

containers/bags, labelling and storage facilities

sampling schedules and test procedures and equipment as required

documentation and recording requirements and procedures

cleaning procedures, materials and equipment as required.

Method of assessment

This unit should be assessed together with core units and other units of competency relevant to the function or work role. Examples could be:

FDFOP2004A Clean and sanitise equipment

FDFOP2013A Apply sampling procedures

MSL973001A Perform basic tests.

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.

Submission Requirements

List each assessment task's title, type (eg project, observation/demonstration, essay, assingnment, checklist) and due date here

Assessment task 1: [title]      Due date:

(add new lines for each of the assessment tasks)

Assessment Tasks

Copy and paste from the following data to produce each assessment task. Write these in plain English and spell out how, when and where the task is to be carried out, under what conditions, and what resources are needed. Include guidelines about how well the candidate has to perform a task for it to be judged satisfactory.

Required skills

Ability to:

access workplace information to identify dispensing requirements

select, fit and use personal protective clothing and/or equipment, such as breathing apparatus and fume cabinets as required

confirm supply of necessary raw materials, such as checking raw material labels and codes, quantity and quality clearance

conduct pre-start checks on equipment, such as inspecting the condition and cleanliness of equipment and utensils, taring scales and carrying out any related procedures to confirm that equipment is accurately calibrated and fit for use

measure materials and additives within specified accuracy range to meet batch requirements

calculate assay/potency adjustment

verify accuracy of raw materials dispensed with raw materials records

take corrective action in response to out-of-specification results

pace dispensing to meet production requirements

pack and label dispensed materials as required

follow labelling procedures

reconcile and record materials dispensed against materials released and return unused materials to storage as required

stack dispensed materials for transfer to designated location ensuring required material segregation

handle containers according to workplace procedures to maintain integrity of materials

clean dispensing equipment and utensils according to workplace procedures

respond to and/or report equipment failure within level of responsibility

complete dispensing records as required by workplace recording system

maintain work area to meet housekeeping standards

collect samples and conduct test according to enterprise procedures

use oral communication skills/language competence to fulfil the job role as specified by the organisation, including questioning, active listening, asking for clarification and seeking advice from supervisor

work cooperatively within a culturally diverse workforce

Required knowledge

Knowledge of:

purpose and basic principles of the dispensing process, including the characteristics of raw materials and related handling requirements

dangerous goods handling requirements and procedures

relevant legislative responsibilities and workplace systems for recording information on dispensed pharmaceutical materials and related workplace coding and labelling systems and purpose

the relationship between the dispensing process and related operations, including an understanding of accuracy/tolerance and consequence of error

purpose, measuring/accuracy capacity of instrumentation and related equipment calibration responsibilities and procedures

control points in the dispensing process

procedures for calculating assay and adjusting potency

raw materials reconciliation purpose and procedures, such as reconciliation of S8 materials

GMP requirements associated with the dispensing process and related control measures

procedures for requisitioning, receiving and returning ingredients from stores

typical equipment faults and related causes, including signs and symptoms of faulty equipment and early warning signs of potential problems

occupational health and safety (OHS) hazards and controls, including the limitations of protective clothing and equipment relevant to the work process

cleaning, care and storage of equipment and instrumentation used

procedures and responsibility for reporting production and performance information

environmental issues and controls relevant to the dispensing process, including waste/rework collection and handling procedures related to the process

sampling and testing associated with process monitoring and control where relevant

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.

Policies and procedures

Work is carried out according to company policies and procedures, regulatory and licensing requirements, legislative requirements, and industrial awards and agreements

Legislative requirements

Legislative requirements are typically reflected in procedures and specifications. Legislation relevant to this industry includes:

relevant Good Manufacturing Practice (GMP) codes

the Therapeutic Goods Act and/or other relevant legislation

legislation covering environmental management, OHS, anti-discrimination and equal opportunity

Workplace information

Workplace information may include:

standard operating procedures (SOPs)

specifications

production/dispensing schedules and instructions

batch/recipe instructions

manufacturers' advice

standard forms and reports

Dispensing equipment

Dispensing equipment may include:

scales

pipettes

calibrated measuring containers

fume cabinets

labels/printers and related dispensary instrumentation

Raw materials

Raw materials may include:

drugs of addiction classified as S8

Operation of equipment and processes

Operation of equipment and processes may require:

the use of process control panels and systems

Copy and paste from the following performance criteria to create an observation checklist for each task. When you have finished writing your assessment tool every one of these must have been addressed, preferably several times in a variety of contexts. To ensure this occurs download the assessment matrix for the unit; enter each assessment task as a column header and place check marks against each performance criteria that task addresses.

Observation Checklist

Tasks to be observed according to workplace/college/TAFE policy and procedures, relevant legislation and Codes of Practice Yes No Comments/feedback
Materials are inspected to confirm type, quality clearance, quantities and identify any obvious contamination or non-compliance 
Measuring and weighing equipment is selected appropriate to dispensing requirements and checked to confirm readiness for use 
Containers/bags and labels are available as required 
Pre-start checks are carried out as required by workplace requirements 
Non-bulk ingredients and additives are weighed/measured to meet production requirements 
Dispensed ingredients are labelled according to workplace procedure 
Accuracy of measuring/dispensing equipment is monitored to identify variation in operating conditions 
Variation in equipment operation is identified and maintenance requirements are reported according to workplace reporting requirements 
The work area is maintained according to housekeeping standards 
Work is conducted in accordance with workplace environmental guidelines 
Dispensing equipment is cleaned according to workplace procedure 
Unacceptable equipment/utensil condition is identified and reported 
Dispensed materials are recorded and reconciled 
Maintenance requirements are identified and reported 

Forms

Assessment Cover Sheet

FDFPH2009A - Dispense pharmaceutical raw materials
Assessment task 1: [title]

Student name:

Student ID:

I declare that the assessment tasks submitted for this unit are my own work.

Student signature:

Result: Competent Not yet competent

Feedback to student

 

 

 

 

 

 

 

 

Assessor name:

Signature:

Date:

Assessment Record Sheet

FDFPH2009A - Dispense pharmaceutical raw materials

Student name:

Student ID:

Assessment task 1: [title] Result: Competent Not yet competent

(add lines for each task)

Feedback to student:

 

 

 

 

 

 

 

 

Overall assessment result: Competent Not yet competent

Assessor name:

Signature:

Date:

Student signature:

Date: