Assessor Resource

FDFPH4002A
Facilitate and monitor Good Manufacturing Practice

Assessment tool

Version 1.0
Issue Date: May 2024


This unit applies to people working in supervisory or line management production/packaging roles. This person would typically work within defined GMP programs and procedures. They contribute to the development of these programs as a team member and are responsible to oversee implementation in their work area.

This unit of competency targets content outlined in Chapter 4 of the Australian Code of Good Manufacturing Practice for Medicinal Products and should be read in conjunction with this document. It covers the skills and knowledge required to facilitate and monitor Good Manufacturing Practice (GMP) in a production/packaging work area.

You may want to include more information here about the target group and the purpose of the assessments (eg formative, summative, recognition)

Employability Skills

This unit contains employability skills.



Evidence Required

List the assessment methods to be used and the context and resources required for assessment. Copy and paste the relevant sections from the evidence guide below and then re-write these in plain English.

The Evidence Guide provides advice on assessment and must be read in conjunction with the performance criteria, required skills and knowledge, range statement and the Assessment Guidelines for the Training Package.

Overview of assessment

Assessment may occur in a real or simulated pharmaceutical or complementary medicine manufacturing workplace where the assessment environment provides access to workplace documentation and document management systems related to GMP that are typical of commercial manufacturing businesses and meet the requirements of the Therapeutic Goods Act. It will also provide a range of commercial production/packaging equipment and activities typically used in a commercial manufacturing environment.

Critical aspects for assessment and evidence required to demonstrate competency in this unit

Evidence of participation in a project team to develop or review systems and procedures to support GMP in a work area. This includes providing evidence that the candidate:

provides documented evidence through use of workplace documentation and records to show that the work preparation, processing and completion meet GMP requirements

leads response to a failure or non-conformance in the work area. This must include conducting risk assessment, analysing root cause analysis, identifying corrective and preventive action and monitoring implementation. This aspect of assessment may be undertaken as part of a team.

Context of and specific resources for assessment

Assessors must be satisfied that the person can consistently perform the unit as a whole, including all elements, performance criteria, and required skills and knowledge. A holistic approach should be taken to the assessment.

Assessment of this unit would typically involve responding to 'what if' scenarios, answering questions and conducting workplace projects.

Method of assessment

This unit is a core requirement for all pharmaceutical operators at AQF 4 and 5. It could be assessed concurrently with other units relating to problem solving and process improvement. Examples could be:

FDFOP2015A Apply principles of statistical process control

FDFPH4001A Prepare and review workplace documentation to support Good Manufacturing Practice

FDFPH4003A Facilitate contamination control

FDFPH4004A Participate in change control procedures

FDFPH4005A Participate in validation processes

MSACMT450A Undertake process capability improvements.

Guidance information for assessment

To ensure consistency in one's performance, competency should be demonstrated on more than one occasion over a period of time in order to cover a variety of circumstances, cases and responsibilities, and where possible, over a number of assessment activities.

Submission Requirements

List each assessment task's title, type (eg project, observation/demonstration, essay, assingnment, 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.

Required skills

Ability to:

locate regulations, codes, guides and internal company documentation relevant to GMP and products/processes used in the work area

use communication and document management systems to access and review relevant documents

ensure that operators have the

use communication skills to interpret and complete work information to support operations of work team or area

demonstrate and support cooperative work practices within a culturally diverse workforce

Required knowledge

Knowledge of:

legislative framework and structure, including the role of regulations, codes and guides

corporate and personal responsibility and liability for maintaining GMP in the workplace

the Pharmaceutical Inspection Co-operation Scheme (PICS) and related cross-recognition agreements

the content covered by the Therapeutic Goods Act, relevant codes and guides

sources of technical advice on test methods and critical limits

regulatory mechanisms including audit processes

the principles of quality management, quality assurance and quality control and the role of these activities in supporting GMP

principles of risk management and related procedures

system for raising and managing corrective and preventative actions

specific requirements to be met by manufacturing and/or packaging activities in the work area to meet GMP requirements

calibration programs and responsibilities

procedures for reconciling materials and consumables and investigating discrepancies

training system, including assessment methods and documentation

purpose, procedure and responsibility for specific systems, programs and procedures to support GMP

root cause analysis techniques

workplace documentation and authorisation procedures

The range statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Bold italicised wording, if used in the performance criteria, is detailed below. Essential operating conditions that may be present with training and assessment (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) may also be included.

Regulations, codes and guides

Relevant regulations, codes and guides include:

Therapeutic Goods Act

Therapeutic Goods Regulations

Australian Code of Good Manufacturing Practice for Medicinal Products

Therapeutic Goods Act guides to interpretation of legal requirements

regulations, codes and guides related to other relevant international legislation (appropriate to product and market)

company policies and guidelines

Workplace documentation

Workplace documentation relevant to work area activities includes:

company policies and guidelines

specifications

manufacturing formulae

processing and packaging instructions

batch production and packaging records

standard operating procedures (SOPs)

occupational health and safety (OHS) information, including material safety data sheets (MSDS)

Work practices

Work is carried out according to:

company policies and procedures

legislative and licensing requirements, including therapeutic goods legislation, weights and measures and legislation relating to OHS, environmental management, equal opportunity and affirmative action, industrial awards and agreements

Sources of technical advice

Sources of technical advice include but are not limited to:

Therapeutic Goods Administration

British Pharmacopeia

European Pharmacopeia

US Pharmacopeia

Systems, programs and procedures to support GMP

Systems, programs and procedures to support GMP includes but is not limited to:

line clearance

cleaning and sanitation

process control

control of cross-contamination

failure investigation

change control

validation

record keeping and documentation management

release for sale

internal audits

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
Regulations, codes and guides relevant to the work area are identified 
Workplace documentation relevant to work area activities is identified and reviewed to confirm that GMP requirements are met 
The required facilities, materials, storage, equipment and personnel are confirmed and available 
Operators who have the required competence to perform production/packaging activities to company and GMP standards are identified 
Line clearance procedures are carried out 
Critical processes are validated according to validation requirements 
Procedures to eliminate or control the risk of cross-contamination are followed 
Work practices conform to GMP requirements 
In-process and environmental monitoring is carried out and recorded as required by GMP 
Personal hygiene and conduct of personnel in the work area meets GMP requirements 
Personnel movement between work areas complies with entry and exit procedures 
GMP-related data is recorded to meet workplace reporting requirements 
The scope of failures or non-conformances are defined 
Procedures to follow in the event of a failure are documented 
Failures are investigated to determine root causes 
Risk assessment is conducted 
Findings are reported to meet GMP requirements 
Procedures are followed to implement and monitor corrective and preventative action 
Processes are reviewed to ensure all procedures are complete 
Line logs are reviewed to ensure documentation is complete 
End-of-batch procedures are followed 

Forms

Assessment Cover Sheet

FDFPH4002A - Facilitate and monitor Good Manufacturing Practice
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

FDFPH4002A - Facilitate and monitor Good Manufacturing Practice

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: