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Evidence Guide: FBPPHM4005 - Participate in validation of pharmaceutical manufacturing processes

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

 

FBPPHM4005 - Participate in validation of pharmaceutical manufacturing processes

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

Participate in qualification processes for facilities, systems or equipment

  1. Identify procedures for developing and implementing qualification processes
  2. Develop and review qualification processes and documentation according to workplace procedures
  3. Implement qualification process training needs
Identify procedures for developing and implementing qualification processes

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Develop and review qualification processes and documentation according to workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Implement qualification process training needs

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Participate in validation processes for facilities, systems or equipment

  1. Identify validation requirements according to workplace procedures and GMP requirements
  2. Follow validation protocol to support validation activities in the work area
  3. Evaluate and document deviations and exceptions from protocol
  4. Maintain workplace records and documents according to workplace procedures and GMP requirements
Identify validation requirements according to workplace procedures and GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Follow validation protocol to support validation activities in the work area

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Evaluate and document deviations and exceptions from protocol

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Maintain workplace records and documents according to workplace procedures and GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

Required Skills and Knowledge