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Evidence Guide: FBPPHM3001 - Apply Good Manufacturing Practice requirements

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

 

FBPPHM3001 - Apply Good Manufacturing Practice requirements

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

Identify GMP as a regulatory concept

  1. Locate sources of information relevant to work role from current Australian and other applicable regulatory frameworks for manufacturing pharmaceuticals
  2. Locate sources of information relevant to work role relating to current global harmonisation of GMP compliance and product registrations
Locate sources of information relevant to work role from current Australian and other applicable regulatory frameworks for manufacturing pharmaceuticals

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Locate sources of information relevant to work role relating to current global harmonisation of GMP compliance and product registrations

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify requirements of GMP related to own work

  1. Locate sources of information on GMP requirements in the workplace
  2. Identify GMP requirements for pharmaceutical manufacture tasks
  3. Confirm specific GMP requirements for own work
  4. Identify GMP non-compliant situations and risks to product quality
  5. Alert relevant personnel and take appropriate action according to GMP requirements and workplace procedures
Locate sources of information on GMP requirements in the workplace

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify GMP requirements for pharmaceutical manufacture tasks

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Confirm specific GMP requirements for own work

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify GMP non-compliant situations and risks to product quality

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Alert relevant personnel and take appropriate action according to GMP requirements and workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Complete workplace documentation to support GMP

  1. Use workplace procedures to identify GMP requirements for documentation
  2. Record information, including calculations and test results according to workplace reporting procedures and GMP requirements
  3. Certify records, including electronic records, according to GMP requirements
Use workplace procedures to identify GMP requirements for documentation

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Record information, including calculations and test results according to workplace reporting procedures and GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Certify records, including electronic records, according to GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify and follow biosecurity requirements

  1. Identify information appropriate to work role relating to biosecurity requirements
  2. Follow workplace biosecurity requirements and responsibilities related to work role
Identify information appropriate to work role relating to biosecurity requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Follow workplace biosecurity requirements and responsibilities related to work role

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Apply GMP requirements when carrying out work activities

  1. Identify common forms of contamination
  2. Conduct work according to workplace environmental procedures
  3. Maintain workplace cleanliness and tidiness to meet GMP requirements
  4. Identify and report signs of unacceptable plant or equipment condition, including calibration status
  5. Identify GMP requirements for routinely monitoring work area, materials, equipment and product
  6. Complete documentation according to workplace procedures
Identify common forms of contamination

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Conduct work according to workplace environmental procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Maintain workplace cleanliness and tidiness to meet GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify and report signs of unacceptable plant or equipment condition, including calibration status

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify GMP requirements for routinely monitoring work area, materials, equipment and product

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Complete documentation according to workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Ensure personal hygiene and conduct meet GMP requirements

  1. Maintain personal hygiene to meet GMP requirements
  2. Carry out hand washing according to best practice hygiene standards
  3. Prepare, use, store and dispose of personal protective equipment and contamination prevention clothing according to GMP requirements and workplace procedures
  4. Comply with area entry and exit procedures when moving around the workplace
Maintain personal hygiene to meet GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Carry out hand washing according to best practice hygiene standards

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare, use, store and dispose of personal protective equipment and contamination prevention clothing according to GMP requirements and workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Comply with area entry and exit procedures when moving around the workplace

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Participate in improving GMP

  1. Identify processes, practices or conditions which are inconsistent with GMP requirements and report according to workplace procedures
  2. Identify elements of GMP that help improve products and processes
  3. Implement corrective action within level of responsibility
Identify processes, practices or conditions which are inconsistent with GMP requirements and report according to workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify elements of GMP that help improve products and processes

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Implement corrective action within level of responsibility

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

Required Skills and Knowledge