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Evidence Guide: HLTPH408A - Conduct small scale compounding and labelling of pharmaceutical products

Student: __________________________________________________

Signature: _________________________________________________

Tips for gathering evidence to demonstrate your skills

The important thing to remember when gathering evidence is that the more evidence the better - that is, the more evidence you gather to demonstrate your skills, the more confident an assessor can be that you have learned the skills not just at one point in time, but are continuing to apply and develop those skills (as opposed to just learning for the test!). Furthermore, one piece of evidence that you collect will not usualy demonstrate all the required criteria for a unit of competency, whereas multiple overlapping pieces of evidence will usually do the trick!

From the Wiki University

 

HLTPH408A - Conduct small scale compounding and labelling of pharmaceutical products

What evidence can you provide to prove your understanding of each of the following citeria?

Source information on formula

  1. Select appropriate dosage form for product, based on client need and/or against order for medicine
  2. Use validated resources to source available formulae for required product
  3. Consolidate and make relevant information available
  4. Confirm suitability of chosen formula and availability of resources
  5. Obtain authority of pharmacist to proceed
  6. Obtain and clarify the confirmed and formulated manufacturing order or master batch sheet from pharmacist, when required
Select appropriate dosage form for product, based on client need and/or against order for medicine

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Use validated resources to source available formulae for required product

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Consolidate and make relevant information available

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Confirm suitability of chosen formula and availability of resources

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain authority of pharmacist to proceed

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain and clarify the confirmed and formulated manufacturing order or master batch sheet from pharmacist, when required

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare for production process

  1. Comply with dress code, safety and personal hygiene procedures prior to entering the work area
  2. Clean work area and equipment correctly
  3. Maintain inventory levels of raw materials and disposable equipment
  4. Prepare a batch/work sheet referenced from a master sheet or formulae
  5. Assign product batch number, if required
  6. Verify that batch/work sheets are clearly written in logical order with clear directions and contain all the required information
  7. Generate the product labels referenced from a master label
  8. Check and note the number of labels generated
  9. Submit batch/work sheet and labels to pharmacist for approval
  10. Check and set up equipment
Comply with dress code, safety and personal hygiene procedures prior to entering the work area

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Clean work area and equipment correctly

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Maintain inventory levels of raw materials and disposable equipment

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare a batch/work sheet referenced from a master sheet or formulae

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assign product batch number, if required

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Verify that batch/work sheets are clearly written in logical order with clear directions and contain all the required information

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Generate the product labels referenced from a master label

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Check and note the number of labels generated

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Submit batch/work sheet and labels to pharmacist for approval

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Check and set up equipment

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain and process raw materials

  1. Acquire all materials listed on the worksheet according to stock levels and stock requisitioning procedures
  2. Check raw materials to ensure they have been released from quarantine for use by authorised persons
  3. Verify raw materials against manufacturing work sheet and record raw material batch numbers and expiry dates
  4. Weigh or measure raw materials in designated area
  5. Obtain required authorisation or checks at designated points according to work sheet
Acquire all materials listed on the worksheet according to stock levels and stock requisitioning procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Check raw materials to ensure they have been released from quarantine for use by authorised persons

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Verify raw materials against manufacturing work sheet and record raw material batch numbers and expiry dates

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Weigh or measure raw materials in designated area

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain required authorisation or checks at designated points according to work sheet

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Compound products

  1. Allocate approved raw materials to equipment according to batch documentation
  2. Compound product according to method on work sheet
  3. Monitor product and adjust any necessary pharmaceutical/compounding to ensure product complies with work sheet specifications
  4. Perform verification procedures, inspect finished product for deviations and report to authorised person
  5. Pack compounded product into appropriate container as specified on the work sheet, and following approval from an authorised person
  6. Label containers/units according to labelling specifications on the work sheet
  7. Obtain required authorisation or checks at designated points
Allocate approved raw materials to equipment according to batch documentation

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Compound product according to method on work sheet

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Monitor product and adjust any necessary pharmaceutical/compounding to ensure product complies with work sheet specifications

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Perform verification procedures, inspect finished product for deviations and report to authorised person

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Pack compounded product into appropriate container as specified on the work sheet, and following approval from an authorised person

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Label containers/units according to labelling specifications on the work sheet

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain required authorisation or checks at designated points

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Complete production process

  1. Reconcile the number of labels printed with number used and discard excess, noting and documenting discrepancies in labels
  2. Place product in quarantinearea under appropriate storage conditions
  3. Clean machinery and manufacturing area and dispose of disposable equipment safely
  4. Complete all required documentation and forward to an authorised person
  5. Report all discrepancies to an authorised person
  6. Obtain final approval from the pharmacist before releasing packed medicines to storage areas
Reconcile the number of labels printed with number used and discard excess, noting and documenting discrepancies in labels

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Place product in quarantinearea under appropriate storage conditions

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Clean machinery and manufacturing area and dispose of disposable equipment safely

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Complete all required documentation and forward to an authorised person

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Report all discrepancies to an authorised person

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain final approval from the pharmacist before releasing packed medicines to storage areas

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Participate in quality control

  1. Pack and label a retention sample and/or quality control sample if specified on the work sheet
  2. Submit product sample and relevant documentation to quality control, where specified
  3. Record and file product quality control assay results
Pack and label a retention sample and/or quality control sample if specified on the work sheet

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Submit product sample and relevant documentation to quality control, where specified

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Record and file product quality control assay results

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Store and transport released product

  1. Store products according to manufacturing documentation
  2. Obtain released product(s) from quarantine store
  3. Pack released product(s) into delivery containers which will maintain the required ambient conditions for the product
  4. Deliver product to destination
  5. Advise receipting area personnel of specific storage requirements
  6. Complete and file records and/or work sheets
Store products according to manufacturing documentation

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain released product(s) from quarantine store

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Pack released product(s) into delivery containers which will maintain the required ambient conditions for the product

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Deliver product to destination

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Advise receipting area personnel of specific storage requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Complete and file records and/or work sheets

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

Evidence Guide

The evidence guide provides advice on assessment and must be read in conjunction with the Performance Criteria, Required Skills and Knowledge, the Range Statement and the Assessment Guidelines for this Training Package.

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

The individual being assessed must provide evidence of specified essential knowledge as well as skills

Observation of workplace performance is desirable for assessment of this unit

Consistency of performance should be demonstrated over the required range of situations relevant to the workplace

Where, for reasons of safety, space, or access to equipment and resources, assessment takes place away from the workplace, the assessment environment should represent workplace conditions as closely as possible

Context of and specific resources for assessment:

Assessment should replicate workplace conditions as far as possible

Simulations may be used to represent workplace conditions as closely as possible
Acceptable simulation requires:

scope to determine that work is conducted within legislative and regulatory requirements

scope to determine that work is conducted within WHS and infection control requirements

Resources essential for assessment include:

access to relevant workplace or a simulated environment where assessment can take place

instructions on the use of equipment

relevant legislation, regulations and guidelines

relevant manufacturing and packing machinery

weighing and measuring equipment

Method of assessment may include:

Formal appraisal systems

Interviewing and questioning

Observation in the work place

Supporting statement of supervisor(s)

Written assignments/projects

Access and equity considerations:

All workers in the health industry should be aware of access and equity issues in relation to their own area of work

All workers should develop their ability to work in a culturally diverse environment

In recognition of particular health issues facing Aboriginal and Torres Strait Islander communities, workers should be aware of cultural, historical and current issues impacting on health of Aboriginal and Torres Strait Islander people

Assessors and trainers must take into account relevant access and equity issues, in particular relating to factors impacting on health of Aboriginal and/or Torres Strait Islander clients and communities

Required Skills and Knowledge

This describes the essential skills and knowledge and their level required for this unit.

Essential knowledge:

The candidate must be able to demonstrate essential knowledge required to effectively do the task outlined in elements and performance criteria of this unit, manage the task and manage contingencies in the context of the identified work role

This includes knowledge of:

Formulated manufacturing order / master batch sheet which must:

be clearly written

be in logical order

contain all required information

contain no ambiguous information

Identification and handling of products, including:

formulary medicines and non-formulary medicines e.g. clinical trial medicines and Special Access Acheme (SAS) medicines

products with the required integrity as well as those whose integrity has been compromised e.g. damaged, contaminated or deteriorated stock

routine handling of products and products requiring special handling, e.g. refrigerated and frozen items, light sensitive materials and flammables

Infection control principles related to small scale manufacture of pharmaceutical products including:

correct disposal of sharps, drug residues etc

hygiene and maintaining a clean working environment and equipment, including the principles of cleaning and disinfection

personal hygiene and the use of protective clothing when conducting small scale compounding pharmaceutical products

sources and types of contamination – microbial, cross-chemical, physical, environmental; and corrective strategies

Knowledge of and the rationale for The Society of Hospital Pharmacists (SHPA) Guidelines for Medicines Prepared in Australian Hospital Pharmacy Departments, the Pharmaceutical Inspection Convention / Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to good practices for the preparation of medicinal products in healthcare establishments (PE010-3) and applicable legislation, organisation policy and in-house standard operating procedures (SOPs) relating to small scale compounding of pharmaceutical products

Labelling requirements for compounded products, including:

adherence to legislative requirements

contain name, form and strength of product

include ancillary labels as part of label details

include hazard warnings

provide spacing for entry of batch numbers and expiry dates

Limitations of own work role including identification and referring of issues outside scope of practice to the authorised person

Nature and use of two different dosage forms i.e. oral and topical

Work Health and Safety (WHS) policies, guidelines and symbols and their relevance to small scale compounding of pharmaceutical products

Packaging methods, container materials and principles for selection

Pharmacy or health facility computer systems related to small scale compound / manufacture of pharmaceutical products

Preparation of worksheets

Principles and practices of ethical and professional codes of conduct

Principles and procedures of maintaining security of pharmaceutical products

Principles of handling and storage of hazardous materials

Principles and procedures for implementing a quarantine period related to pharmaceutical products

Principles of manufacturing processes relating to small scale compounding, including:

chemical and physical properties of raw materials in relation to formulation and compounding

compounding of a product according to a work sheet

principles and procedures of formulae calculations, weights and measures

processes for dilution, suspension, incorporation and reconstitution

Principles of record keeping and required documentation to be completed

Purpose of information to be shown on medicine packs, e.g. product name, batch numbering and expiry date

Standard pharmaceutical references including Australian Pharmaceutical Formulary (APF), MIMs, AMH and Micromedex

Storage requirements and rationale for different types of product including hazardous materials, special storage conditions include inflammable store, refrigeration

Essential skills:

It is critical that the candidate demonstrate the ability to:

Complete and file required documentation

Correctly and safely prepare, process and manufacture quality pharmaceutical products from fixed formulae

Identify issues outside scope of practice and refer to the authorised person

Perform quality assurance monitoring

Prepare batch/work sheet and labels

Produce a product free from microbial or cross contamination

Transport and store products to meet requirements

Work in accordance with relevant work health and safety, and infection control guidelines

Work in accordance with The Society of Hospital Pharmacists (SHPA) Guidelines for Medicines Prepared in Australian Hospital Pharmacy Departments, the Pharmaceutical Inspection Convention / Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to good practices for the preparation of medicinal products in healthcare establishments (PE010-3) and with relevant organisation policy, legislative requirements, industrial awards and agreements and in-house standard operating procedures (SOPs)

Work in accordance with relevant work health and safety, and infection control guidelines

In addition, the candidate must be able to effectively do the task outlined in elements and performance criteria of this unit, manage the task and manage contingencies in the context of the identified work role

This includes the ability to:

Assemble, maintain, clean and use all equipment used in manufacturing process in the required manner and ensure a clean work environment. Cleaning methods include:

de-scaling

disinfecting

soaking

sweeping

washing

wiping

Complete manufacturing process including:

calculate medicine and other stock requirements for manufacturing

complete required documentation related to manufacturing task

compound an item according to master batch/work sheet

select and maintain appropriate equipment for manufacturing task

Take into account opportunities to address waste minimisation, environmental responsibility and sustainable practice issues

Use available resources and prioritise workload

Use literacy, numeracy and oral communication skills required to fulfil the position in a safe manner as specified by the health care facility

Use problem solving skills

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. Add any 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.

Information may include:

Equipment required

Packaging and label requirements

Preparation instructions

Raw drug materials list

Storage and stability data

Raw materials may include:

Agents considered inactive, that are required for bulking, stabilising, colouring and flavouring the final product

Therapeutic agents

Master sheet or formulae must:

Be clearly written

Be in logical order

Contain all required information

Contain no ambiguous directions

Equipment includes equipment and machinery required for manufacturing or compounding and may include:

Autoclaves

Balances

Beakers

Extractors

Filters

Gauges

Gloves

Goggles

Masks

Measures

Meters

Mixers

Needles

Ointment slabs

Pestle and mortar

Pumps

Spatulas

Stills

Syringes

Compound product may include:

Aggregation

Dissolution

Emulsification

Grinding

Mixing

Suspension

Trituration

Pack compounded product may include:

Client ready units

Bulk containers

Containers may include:

Bottles (medical and poison)

Glass jars

Miscellaneous individual client unit devices

Syringes

Tubes

Labels may be:

Electronically produced

Typed

Written

Storage conditions may include:

Ambient

Correct storage of hazardous substances

Correct temperature

Humidity

Isolated

Light

Secure and safe storage for controlled drugs

Secured

Ventilated

All required documentation may include:

Machinery and equipment records

Machinery and equipment logs

Destination may include:

Client care area

Dispensary

Store