Unit of Competency Mapping – Information for Teachers/Assessors – Information for Learners

FBPPHM4002 Mapping and Delivery Guide
Prepare and review workplace documentation to support Good Manufacturing Practice requirements

Version 1.0
Issue Date: May 2024


Qualification -
Unit of Competency FBPPHM4002 - Prepare and review workplace documentation to support Good Manufacturing Practice requirements
Description
Employability Skills
Learning Outcomes and Application This unit of competency describes the skills and knowledge required to develop, review and communicate workplace operations documentation to support Good Manufacturing Practice (GMP) in a pharmaceutical manufacturing facility.The unit applies to individuals with specialised skills and knowledge of GMP requirements who manage and maintain documentation relevant to pharmaceutical manufacturing operations 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.
Duration and Setting X weeks, nominally xx hours, delivered in a classroom/online/blended learning setting.
Prerequisites/co-requisites
Competency Field
Development and validation strategy and guide for assessors and learners Student Learning Resources Handouts
Activities
Slides
PPT
Assessment 1 Assessment 2 Assessment 3 Assessment 4
Elements of Competency Performance Criteria              
Element: Review and draft workplace documentation to meet GMP requirements
  • Identify workplace documentation requiring development or review according to workplace documentation management process and GMP requirements
  • Initiate documentation changes according to change control process
  • Review workplace documentation in consultation with relevant stakeholders to support GMP
  • Draft workplace documentation in consultation with relevant stakeholders to support GMP
  • Ensure workplace documentation explains complex information in a simple and clear manner
       
Element: Finalise workplace documentation to meet GMP requirements
  • Complete final version of documentation according to documentation management process
  • Submit final version of documentation for approval according to change control process
       

Submission Requirements

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

Assessment task 1: [title]      Due date:

(add new lines for each of the assessment tasks)


Assessment Tasks

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 workplace documentation requiring development or review according to workplace documentation management process and GMP requirements 
Initiate documentation changes according to change control process 
Review workplace documentation in consultation with relevant stakeholders to support GMP 
Draft workplace documentation in consultation with relevant stakeholders to support GMP 
Ensure workplace documentation explains complex information in a simple and clear manner 
Complete final version of documentation according to documentation management process 
Submit final version of documentation for approval according to change control process 

Forms

Assessment Cover Sheet

FBPPHM4002 - Prepare and review workplace documentation to support Good Manufacturing Practice requirements
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

Feedback to student

 

 

 

 

 

 

 

 

Assessor name:

Signature:

Date:


Assessment Record Sheet

FBPPHM4002 - Prepare and review workplace documentation to support Good Manufacturing Practice requirements

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: