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Evidence Guide: HLTPHA011 - Pack 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

 

HLTPHA011 - Pack pharmaceutical products

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

Prepare for packaging.

  1. Comply with personal protection equipment (PPE), safety requirements and personal hygiene procedures prior to entering the packaging area.
  2. Obtain packaging documentation and work sheet and interpret instructions from authorised person and according to packaging specifications.
  3. Clean and prepare work area according to work sheet or equivalent documentation.
  4. Identify, clean, prepare and set packaging equipment.
  5. Identify and report discrepancies in equipment functioning and take corrective action according to the instructions of an authorised person.
  6. Obtain appropriate and sufficient packaging materials according to stock issuing procedures.
  7. Obtain approved medication.
  8. Prepare and check labels according to work sheet and legal requirements.
  9. Ensure stock expiry date, batch number and other relevant stock details are correct prior to commencing pre-packs.
  10. Submit work sheet and labels to authorised person for approval.
  11. Use appropriate packaging equipment to pack products.
  12. Label container or units according to labelling specifications on the work sheet.
  13. Apply in-process controls and record results accurately.
  14. Report deviations to an authorised person and take corrective action according to instructions from an authorised person.
Comply with personal protection equipment (PPE), safety requirements and personal hygiene procedures prior to entering the packaging area.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain packaging documentation and work sheet and interpret instructions from authorised person and according to packaging specifications.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Clean and prepare work area according to work sheet or equivalent documentation.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify, clean, prepare and set packaging equipment.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify and report discrepancies in equipment functioning and take corrective action according to the instructions of an authorised person.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain appropriate and sufficient packaging materials according to stock issuing procedures.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain approved medication.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare and check labels according to work sheet and legal requirements.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Ensure stock expiry date, batch number and other relevant stock details are correct prior to commencing pre-packs.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Submit work sheet and labels to authorised person for approval.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Use appropriate packaging equipment to pack products.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Label container or units according to labelling specifications on the work sheet.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Apply in-process controls and record results accurately.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Report deviations to an authorised person and take corrective action according to instructions from an authorised person.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Conduct quality control.

  1. Obtain approval from an authorised person at designated points in the packaging process according to work sheet.
  2. Obtain relevant quality control documentation and check product specifications according to work sheet.
  3. Reconcile and verify packaging materials under supervision of an authorised person.
  4. Complete required documentation and submit sample pre-pack for quality audit.
Obtain approval from an authorised person at designated points in the packaging process according to work sheet.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain relevant quality control documentation and check product specifications according to work sheet.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Reconcile and verify packaging materials under supervision of an authorised person.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Complete required documentation and submit sample pre-pack for quality audit.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Complete packaging process.

  1. Reconcile number of labels printed with number used and report discrepancies to an authorised person.
  2. Alert an authorised person of excess materials.
  3. Complete batch documentation and forward according to standard operating procedures.
  4. Obtain final approval from an authorised person before releasing packed medication or product to storage areas.
  5. Clean equipment according to manufacturers’ instructions.
Reconcile number of labels printed with number used and report discrepancies to an authorised person.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Alert an authorised person of excess materials.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Complete batch documentation and forward according to standard operating procedures.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain final approval from an authorised person before releasing packed medication or product to storage areas.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Clean equipment according to manufacturers’ instructions.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

Required Skills and Knowledge