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

FBPPHM4001 Mapping and Delivery Guide
Monitor and maintain Good Manufacturing Practice requirements

Version 1.0
Issue Date: May 2024


Qualification -
Unit of Competency FBPPHM4001 - Monitor and maintain Good Manufacturing Practice requirements
Description
Employability Skills
Learning Outcomes and Application This unit of competency describes the skills and knowledge required to provide a leadership role in the day-to-day monitoring and maintenance of Good Manufacturing Practice (GMP) in a pharmaceutical manufacturing facility.The unit applies to individuals with specialised skills and knowledge of GMP requirements who communicate workplace policies and procedures 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: Empower team members to identify GMP requirements
  • Ensure personal protective equipment and contamination prevention clothing used by team members is serviceable and fitted correctly according to work health and safety requirements
  • Ensure GMP requirements and workplace procedures are available
  • Identify and address training needs according to team member's level of responsibility
  • Provide training and coaching to support individuals and groups to implement GMP requirements and related workplace procedures
  • Demonstrate personal hygiene to others to support implementation of GMP requirements and workplace procedures
  • Monitor and control resource allocation according to workplace procedures and GMP requirements
  • Ensure GMP control measures used in the work area are identifiable by workers
       
Element: Monitor personal hygiene and conduct of team members
  • Ensure personal hygiene of work team meets GMP requirements
  • Prepare, use, store and dispose of personal protective equipment and contamination prevention clothing according to GMP requirements and workplace procedures
  • Ensure personal movements within workplace comply with area entry and exit procedures
       
Element: Monitor implementation of GMP requirements
  • Clearly define, document and follow GMP requirements in work area
  • Conduct a root cause analysis (RCA) as part of a cross-functional team and report non-compliance(s) from workplace procedures
  • Identify and report GMP non-conformance(s) and signs of unacceptable plant or equipment condition
  • Put in place quality approved corrective action or preventative action (CAPA)
  • Record information according to workplace reporting procedures and to meet GMP requirements
  • Ensure team members maintain work area according to workplace cleaning standards
       
Element: Maintain and facilitate continuous improvement of GMP
  • Identify, report and correct processes or conditions which could result in GMP non-conformance according to individual level of responsibility
  • Promptly resolve matters relating to GMP or refer them to appropriate personnel
  • Monitor effectiveness of CAPA and control measures according to level of responsibility
  • Advise others in the work area of GMP matters relevant to their work role
  • Maintain workplace records and documents according to workplace procedures and GMP requirements
       

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.

This section specifies different work environments and conditions that may affect performance. Essential operating conditions that may be present (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) are included.

Personal hygiene must include:

informing team leader or supervisor of any reportable illnesses

removal of jewellery, including:

rings

watches

bracelets

removal of makeup.

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
Ensure personal protective equipment and contamination prevention clothing used by team members is serviceable and fitted correctly according to work health and safety requirements 
Ensure GMP requirements and workplace procedures are available 
Identify and address training needs according to team member's level of responsibility 
Provide training and coaching to support individuals and groups to implement GMP requirements and related workplace procedures 
Demonstrate personal hygiene to others to support implementation of GMP requirements and workplace procedures 
Monitor and control resource allocation according to workplace procedures and GMP requirements 
Ensure GMP control measures used in the work area are identifiable by workers 
Ensure personal hygiene of work team meets GMP requirements 
Prepare, use, store and dispose of personal protective equipment and contamination prevention clothing according to GMP requirements and workplace procedures 
Ensure personal movements within workplace comply with area entry and exit procedures 
Clearly define, document and follow GMP requirements in work area 
Conduct a root cause analysis (RCA) as part of a cross-functional team and report non-compliance(s) from workplace procedures 
Identify and report GMP non-conformance(s) and signs of unacceptable plant or equipment condition 
Put in place quality approved corrective action or preventative action (CAPA) 
Record information according to workplace reporting procedures and to meet GMP requirements 
Ensure team members maintain work area according to workplace cleaning standards 
Identify, report and correct processes or conditions which could result in GMP non-conformance according to individual level of responsibility 
Promptly resolve matters relating to GMP or refer them to appropriate personnel 
Monitor effectiveness of CAPA and control measures according to level of responsibility 
Advise others in the work area of GMP matters relevant to their work role 
Maintain workplace records and documents according to workplace procedures and GMP requirements 

Forms

Assessment Cover Sheet

FBPPHM4001 - Monitor and maintain 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

FBPPHM4001 - Monitor and maintain 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: