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Evidence Guide: HLTPHA007 - Conduct small-scale compounding and labelling of aseptic 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!

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HLTPHA007 - Conduct small-scale compounding and labelling of aseptic pharmaceutical products

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

Elements define the essential outcomes

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Source informationon formula

  1. Select appropriate formula and master work sheet for the product, based on correct interpretation of the prescription or medication order
  2. Confirm suitability of chosen master work sheet and availability of resources
  3. Obtain authority of pharmacist to proceed
Select appropriate formula and master work sheet for the product, based on correct interpretation of the prescription or medication order

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Confirm suitability of chosen master work sheet and availability of resources

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain authority of pharmacist to proceed

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare for production process

  1. Confirm the availability of the appropriate laminar flow hood/clean room or cytotoxic drug safety cabinet/cytotoxic suite or room or isolator required to compound the product according to the work sheet
  2. Comply with dress code, safety and personal hygiene procedures prior to entering the work area
  3. Clean work area and equipment correctly
  4. Maintain inventory levels of materials and disposable equipment
  5. Prepare a work sheet referenced from amaster work sheet
  6. Assign product batch number
  7. Verify that the work sheets are clearly written in logical order with clear directions and contain all the required information
  8. Generate the product labels referenced from the master label detailed on the master work sheet
  9. Check and note the number of labels generated
  10. Submit work sheet and labels to pharmacist for approval
  11. Check and set up compounding requirements and disposable equipment
Confirm the availability of the appropriate laminar flow hood/clean room or cytotoxic drug safety cabinet/cytotoxic suite or room or isolator required to compound the product according to the work sheet

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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 materials and disposable equipment

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare a work sheet referenced from amaster work sheet

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assign product batch number

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Verify that the 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 the master label detailed on the master work sheet

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Check and note the number of labels generated

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Submit work sheet and labels to pharmacist for approval

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Check and set up compounding requirements and disposable equipment

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain equipment and supplies

  1. Assemble materials used in aseptic compounding as listed in the work sheet, according to stock levels and stock requisitioning procedures
  2. Check materials to ensure they have been released from quarantine for use by authorised persons
  3. Verify materials against manufacturing work sheet and record material batch numbers and expiry dates
  4. Select appropriate types, size and features of containers and packaging listed in the work sheet
  5. Weigh or measure materials in designated area
  6. Obtain required authorisation or checks at designated points according to the work sheet
Assemble materials used in aseptic compounding as listed in the work sheet, according to stock levels and stock requisitioning procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Select appropriate types, size and features of containers and packaging listed in the work sheet

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Weigh or measure materials in designated area

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare for sterile manufacturing

  1. Transfer raw materials, disposable equipment, required containers or packaging and covered work sheet to pre-production area
  2. Follow hand washing, gowning and gloving procedures
  3. Disinfect and transfer materials, disposable equipment and work sheet to sterile production area
Transfer raw materials, disposable equipment, required containers or packaging and covered work sheet to pre-production area

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Follow hand washing, gowning and gloving procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Disinfect and transfer materials, disposable equipment and work sheet to sterile production area

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare for cytotoxic production

  1. Check that cytotoxic spill cleaning kits are available in all production areas
  2. Select and use appropriate sterile personal protective equipment for safe handling and preparation of cytotoxic drugs as required
  3. Follow specific procedures to minimise risk of exposure to cytotoxic drugs
Check that cytotoxic spill cleaning kits are available in all production areas

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Select and use appropriate sterile personal protective equipment for safe handling and preparation of cytotoxic drugs as required

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Follow specific procedures to minimise risk of exposure to cytotoxic drugs

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Compound products using aseptic techniques

  1. Allocate approved bulk materials, intermediary products and containers to appropriate equipment
  2. Incorporate materials according to work sheet using appropriate manipulation technique
  3. Compound product according to method on manufacturing work sheet
  4. Prepare cytotoxic products using procedures for safe handling of cytotoxic drugs
  5. Operate specialist equipment and use specialist supplies in sterile production preparation
  6. Perform verification procedures and inspect finished product for deviations and report to authorised person
  7. Pack compounded product into appropriate container as specified on the work sheet, and following approval from an authorised person
  8. Label containers according to labelling specifications on the work sheet
  9. Obtain required authorisation or checks at designated points
Allocate approved bulk materials, intermediary products and containers to appropriate equipment

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Incorporate materials according to work sheet using appropriate manipulation technique

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Compound product according to method on manufacturing work sheet

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare cytotoxic products using procedures for safe handling of cytotoxic drugs

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Operate specialist equipment and use specialist supplies in sterile production preparation

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Perform verification procedures and 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 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 report discrepancies to the pharmacist
  2. Place product in quarantinearea under appropriate storage conditions
  3. Clean machinery and manufacturing area and dispose of disposable equipment safely
  4. Follow procedures for cleaning cytotoxic spills, and exposure to cytotoxic drugs
  5. Complete required documentation and forward to an authorised person
  6. Report discrepancies to an authorised person
  7. Obtain final approval from pharmacist before releasing compounded medicines to storage areas
  8. Discard waste materials appropriately
Reconcile the number of labels printed with number used and report discrepancies to the pharmacist

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:

 

 

 

 

 

 

 

Follow procedures for cleaning cytotoxic spills, and exposure to cytotoxic drugs

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Complete required documentation and forward to an authorised person

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Report discrepancies to an authorised person

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain final approval from pharmacist before releasing compounded medicines to storage areas

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Discard waste materials appropriately

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. Perform environmental monitoring and report abnormal readings to an authorised person
  3. Submit product sample and relevant documentation to quality control
  4. Record and file product quality control assay results and manufacturing area environmental monitoring results
Pack and label a retention sample and/or quality control sample if specified on the work sheet

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Perform environmental monitoring and report abnormal readings to an authorised person

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Submit product sample and relevant documentation to quality control

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Record and file product quality control assay results and manufacturing area environmental monitoring results

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Store and transport released product

  1. Store products according to the work sheet
  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 ensuring safe transport of cytotoxic products
  5. Advise receipting area personnel of storage requirements
  6. Complete and file records and/or work sheets
Store products according to the work sheet

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 ensuring safe transport of cytotoxic products

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Advise receipting area personnel of 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

ELEMENT

PERFORMANCE CRITERIA

Elements define the essential outcomes

Performance criteria describe the performance needed to demonstrate achievement of the element

1. Source informationon formula

1.1 Select appropriate formula and master work sheet for the product, based on correct interpretation of the prescription or medication order

1.2 Confirm suitability of chosen master work sheet and availability of resources

1.3 Obtain authority of pharmacist to proceed

2. Prepare for production process

2.1 Confirm the availability of the appropriate laminar flow hood/clean room or cytotoxic drug safety cabinet/cytotoxic suite or room or isolator required to compound the product according to the work sheet

2.2 Comply with dress code, safety and personal hygiene procedures prior to entering the work area

2.3 Clean work area and equipment correctly

2.4 Maintain inventory levels of materials and disposable equipment

2.5 Prepare a work sheet referenced from amaster work sheet

2.6 Assign product batch number

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

2.8 Generate the product labels referenced from the master label detailed on the master work sheet

2.9 Check and note the number of labels generated

2.10 Submit work sheet and labels to pharmacist for approval

2.11 Check and set up compounding requirements and disposable equipment

3. Obtain equipment and supplies

3.1 Assemble materials used in aseptic compounding as listed in the work sheet, according to stock levels and stock requisitioning procedures

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

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

3.4 Select appropriate types, size and features of containers and packaging listed in the work sheet

3.5 Weigh or measure materials in designated area

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

4. Prepare for sterile manufacturing

4.1 Transfer raw materials, disposable equipment, required containers or packaging and covered work sheet to pre-production area

4.2 Follow hand washing, gowning and gloving procedures

4.3 Disinfect and transfer materials, disposable equipment and work sheet to sterile production area

5. Prepare for cytotoxic production

5.1 Check that cytotoxic spill cleaning kits are available in all production areas

5.2 Select and use appropriate sterile personal protective equipment for safe handling and preparation of cytotoxic drugs as required

5.3 Follow specific procedures to minimise risk of exposure to cytotoxic drugs

6. Compound products using aseptic techniques

6.1 Allocate approved bulk materials, intermediary products and containers to appropriate equipment

6.2 Incorporate materials according to work sheet using appropriate manipulation technique

6.3 Compound product according to method on manufacturing work sheet

6.4 Prepare cytotoxic products using procedures for safe handling of cytotoxic drugs

6.5 Operate specialist equipment and use specialist supplies in sterile production preparation

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

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

6.8 Label containers according to labelling specifications on the work sheet

6.9 Obtain required authorisation or checks at designated points

7. Complete production process

7.1 Reconcile the number of labels printed with number used and report discrepancies to the pharmacist

7.2 Place product in quarantinearea under appropriate storage conditions

7.3 Clean machinery and manufacturing area and dispose of disposable equipment safely

7.4 Follow procedures for cleaning cytotoxic spills, and exposure to cytotoxic drugs

7.5 Complete required documentation and forward to an authorised person

7.6 Report discrepancies to an authorised person

7.7 Obtain final approval from pharmacist before releasing compounded medicines to storage areas

7.8 Discard waste materials appropriately

8. Participate in quality control

8.1 Pack and label a retention sample and/or quality control sample if specified on the work sheet

8.2 Perform environmental monitoring and report abnormal readings to an authorised person

8.3 Submit product sample and relevant documentation to quality control

8.4 Record and file product quality control assay results and manufacturing area environmental monitoring results

9. Store and transport released product

9.1 Store products according to the work sheet

9.2 Obtain released product(s) from quarantine store

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

9.4 Deliver product to destination ensuring safe transport of cytotoxic products

9.5 Advise receipting area personnel of storage requirements

9.6 Complete and file records and/or work sheets

Required Skills and Knowledge

ELEMENT

PERFORMANCE CRITERIA

Elements define the essential outcomes

Performance criteria describe the performance needed to demonstrate achievement of the element

1. Source informationon formula

1.1 Select appropriate formula and master work sheet for the product, based on correct interpretation of the prescription or medication order

1.2 Confirm suitability of chosen master work sheet and availability of resources

1.3 Obtain authority of pharmacist to proceed

2. Prepare for production process

2.1 Confirm the availability of the appropriate laminar flow hood/clean room or cytotoxic drug safety cabinet/cytotoxic suite or room or isolator required to compound the product according to the work sheet

2.2 Comply with dress code, safety and personal hygiene procedures prior to entering the work area

2.3 Clean work area and equipment correctly

2.4 Maintain inventory levels of materials and disposable equipment

2.5 Prepare a work sheet referenced from amaster work sheet

2.6 Assign product batch number

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

2.8 Generate the product labels referenced from the master label detailed on the master work sheet

2.9 Check and note the number of labels generated

2.10 Submit work sheet and labels to pharmacist for approval

2.11 Check and set up compounding requirements and disposable equipment

3. Obtain equipment and supplies

3.1 Assemble materials used in aseptic compounding as listed in the work sheet, according to stock levels and stock requisitioning procedures

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

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

3.4 Select appropriate types, size and features of containers and packaging listed in the work sheet

3.5 Weigh or measure materials in designated area

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

4. Prepare for sterile manufacturing

4.1 Transfer raw materials, disposable equipment, required containers or packaging and covered work sheet to pre-production area

4.2 Follow hand washing, gowning and gloving procedures

4.3 Disinfect and transfer materials, disposable equipment and work sheet to sterile production area

5. Prepare for cytotoxic production

5.1 Check that cytotoxic spill cleaning kits are available in all production areas

5.2 Select and use appropriate sterile personal protective equipment for safe handling and preparation of cytotoxic drugs as required

5.3 Follow specific procedures to minimise risk of exposure to cytotoxic drugs

6. Compound products using aseptic techniques

6.1 Allocate approved bulk materials, intermediary products and containers to appropriate equipment

6.2 Incorporate materials according to work sheet using appropriate manipulation technique

6.3 Compound product according to method on manufacturing work sheet

6.4 Prepare cytotoxic products using procedures for safe handling of cytotoxic drugs

6.5 Operate specialist equipment and use specialist supplies in sterile production preparation

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

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

6.8 Label containers according to labelling specifications on the work sheet

6.9 Obtain required authorisation or checks at designated points

7. Complete production process

7.1 Reconcile the number of labels printed with number used and report discrepancies to the pharmacist

7.2 Place product in quarantinearea under appropriate storage conditions

7.3 Clean machinery and manufacturing area and dispose of disposable equipment safely

7.4 Follow procedures for cleaning cytotoxic spills, and exposure to cytotoxic drugs

7.5 Complete required documentation and forward to an authorised person

7.6 Report discrepancies to an authorised person

7.7 Obtain final approval from pharmacist before releasing compounded medicines to storage areas

7.8 Discard waste materials appropriately

8. Participate in quality control

8.1 Pack and label a retention sample and/or quality control sample if specified on the work sheet

8.2 Perform environmental monitoring and report abnormal readings to an authorised person

8.3 Submit product sample and relevant documentation to quality control

8.4 Record and file product quality control assay results and manufacturing area environmental monitoring results

9. Store and transport released product

9.1 Store products according to the work sheet

9.2 Obtain released product(s) from quarantine store

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

9.4 Deliver product to destination ensuring safe transport of cytotoxic products

9.5 Advise receipting area personnel of storage requirements

9.6 Complete and file records and/or work sheets

The candidate must show evidence of the ability to complete tasks outlined in elements and performance criteria of this unit, manage tasks and manage contingencies in the context of the job role. There must be evidence that the candidate has:

followed established procedures and industry codes to accurately and safely produce 10 aseptic products:

worked within the requirements of sterile areas, air locks, laminar flow hoods and cytotoxic drug safety cabinet/isolators

identified issues outside scope of practice and referred these to the authorised person

The candidate must be able to demonstrate essential knowledge required to effectively complete tasks outlined in elements and performance criteria of this unit, manage tasks and manage contingencies in the context of the work role. This includes knowledge of:

legal and ethical requirements (national, state/territory) for pharmacy work, and how these are applied in organisations, including:

codes of conduct

duty of care (and implications of negligence)

privacy, confidentiality and disclosure

records management

rights and responsibilities of workers, employers and clients

specific legislation:

medicines and their use

the practice of pharmacy

different schedules of medicines and pharmaceutical products

work role boundaries – responsibilities and limitations in manufacturing products

work health and safety

key information in standard pharmaceutical references and their use in manufacturing, including:

Australian pharmaceutical formulary and handbook (APF)

MIMs

Australian medicines handbook (AMH)

Micromedex

rationale and key features of:

The Society of Hospital Pharmacists (SHPA) Standards of practice for the safe handling of cytotoxic drugs in pharmacy departments

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)

product identification and handling, including those for:

formulary medicines and non-formulary medicines

products with the required integrity as well as those whose integrity has been compromised

routine of handling products and products requiring special handling

nature and use of different dosage forms, including:

oral

parenteral products

topical

infection control requirements for small scale compounding of aseptic pharmaceutical products, including:

aseptic technique

correct disposal of sharps and residues

cleaning and disinfection processes plus sterilisation of pharmaceuticals

personal hygiene and clothing standards

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

processes relating to aseptic, including:

calculations for all sterile admixtures

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

principles and procedures of formulae calculations, weights and measures

principles of aseptic technique, including cytotoxic manufacturing

processes for dilution, suspension, incorporation and reconstitution

use of terminal filtration

risk considerations and procedures for pharmaceutical manufacturing:

product security

handling and storage of hazardous materials

quarantine periods

management of cytotoxic spills

specific hazards related to cytotoxic manufacture

transport of cytotoxic medications

requirements for formulated manufacturing documentation, including:

different documentation types, their scope and purpose

worksheet processes

information quality requirements (including clarity, logic and completeness)

specific labelling requirements for compounded products, including:

adherence to legislative requirements

name, form and strength of product

ancillary labels as part of label details

hazard warnings

spacing for entry of batch numbers and expiry dates

packaging methods, container materials and principles for selection

storage and transport requirements and rationale for different types of product including:

hazardous materials

special storage considerations:

humidity

isolation

light

temperature

ventilation

features and use of pharmacy systems used for aseptic compounding

circumstances that require compounding of the product within a laminar flow hood/clean room or cytotoxic drug safety cabinet/cytotoxic suite or room or isolator