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Evidence Guide: HLTPHA014 - 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

 

HLTPHA014 - 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. Interpret medication orders and prescriptions to select formula and master batch sheet for product.
  2. Confirm suitability of chosen master work sheet and availability of resources.
  3. Obtain approval from an authorised person to proceed.
Interpret medication orders and prescriptions to select formula and master batch sheet for product.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain approval from an authorised person to proceed.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare for production process.

  1. Comply with personal protection equipment (PPE), safety and personal hygiene procedures prior to entering the work area.
  2. Clean work area and equipment correctly.
  3. Confirm inventory levels of raw materials and disposable equipment.
  4. Prepare a work sheet referenced from a master work sheet.
  5. Verify that batch or work sheets are clearly written in logical order with clear directions and containing all the required information.
  6. Assign product batch number.
  7. Generate the product labels referenced from the master label detailed on the master work sheet.
  8. Check and note the number of labels generated.
  9. Submit work sheet and labels to an authorised person for approval.
  10. Check and set up compounding requirements and equipment.
Comply with personal protection equipment (PPE), 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:

 

 

 

 

 

 

 

Confirm inventory levels of raw materials and disposable equipment.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare a work sheet referenced from a master work sheet.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Verify that batch or work sheets are clearly written in logical order with clear directions and containing all the required information.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assign product batch number.

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 an authorised person for approval.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Check and set up compounding requirements and equipment.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain equipment and supplies.

  1. Acquire materials listed on the work sheet 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 batch 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.
  6. Allocate approved raw materials to equipment according to batch work sheet.
  7. Compound product according to method on work sheet.
  8. Monitor and adjust compounding to comply with work sheet specifications.
  9. Perform verification procedures, inspect finished product for deviations and report to an authorised person.
  10. Pack compounded product as specified on the work sheet and following approval from an authorised person.
  11. Label containers or units according to labelling specifications on the work sheet.
  12. Obtain required authorisation or checks at designated points.
Acquire materials listed on the work sheet 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 batch 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:

 

 

 

 

 

 

 

Allocate approved raw materials to equipment according to batch work sheet.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Compound product according to method on work sheet.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Monitor and adjust compounding to comply with work sheet specifications.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Pack compounded product as specified on the work sheet and following approval from an authorised person.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Label containers or 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 number of labels printed with number used and report discrepancies to an authorised person.
  2. Place product in quarantine area under appropriate storage conditions.
  3. Clean equipment and compounding 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 an authorised person before releasing packed medication to storage areas.
Reconcile number of labels printed with number used and report discrepancies to an authorised person.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Place product in quarantine area under appropriate storage conditions.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Clean equipment and compounding 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 an authorised person before releasing packed medication to storage areas.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Participate in quality control.

  1. Pack and label a retention sample 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 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 products.

  1. Store products according to work sheet documentation.
  2. Obtain released products from quarantine store.
  3. Pack released products 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 or work sheets.
Store products according to work sheet documentation.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain released products from quarantine store.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Pack released products 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 or work sheets.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

Required Skills and Knowledge