This unit of competency describes the skills and knowledge required to use qualification and validation processes to meet Good Manufacturing Practice (GMP) requirements in a pharmaceutical manufacturing facility.

The unit applies to individuals with specialised skills and knowledge of GMP requirements who participate in validation process relevant to pharmaceutical manufacturing operations as part of a multi-disciplinary team and have responsibility for the output of others. This includes applying and communicating non-routine technical solutions to predictable and unpredictable problems.

No occupational licensing, legislative or certification requirements apply to this unit at the time of publication.

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List each assessment task's title, type (eg project, observation/demonstration, essay, assingnment, checklist) and due date here

Assessment task 1: [title]      Due date:

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Copy and paste from the following data to produce each assessment task. Write these in plain English and spell out how, when and where the task is to be carried out, under what conditions, and what resources are needed. Include guidelines about how well the candidate has to perform a task for it to be judged satisfactory.

Copy and paste from the following performance criteria to create an observation checklist for each task. When you have finished writing your assessment tool every one of these must have been addressed, preferably several times in a variety of contexts. To ensure this occurs download the assessment matrix for the unit; enter each assessment task as a column header and place check marks against each performance criteria that task addresses.

Observation Checklist

Tasks to be observed according to workplace/college/TAFE policy and procedures, relevant legislation and Codes of Practice	Yes	No	Comments/feedback
Identify procedures for developing and implementing qualification processes
Develop and review qualification processes and documentation according to workplace procedures
Implement qualification process training needs
Identify validation requirements according to workplace procedures and GMP requirements
Follow validation protocol to support validation activities in the work area
Evaluate and document deviations and exceptions from protocol
Maintain workplace records and documents according to workplace procedures and GMP requirements

Assessment Cover Sheet

FBPPHM4005 - Participate in validation of pharmaceutical manufacturing processes

Assessment task 1: [title]

Student name:

Student ID:

I declare that the assessment tasks submitted for this unit are my own work.

Student signature:

Result: Competent Not yet competent

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Assessment Record Sheet

FBPPHM4005 - Participate in validation of pharmaceutical manufacturing processes

Student name:

Student ID:

Assessment task 1: [title] Result: Competent Not yet competent

(add lines for each task)

Feedback to student:

 

 

 

 

 

 

 

 

Overall assessment result: Competent Not yet competent

Assessor name:

Signature:

Date:

Student signature:

Date: