NTISthis.com

Evidence Guide: FDFPH4002A - Facilitate and monitor Good Manufacturing Practice

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

 

FDFPH4002A - Facilitate and monitor Good Manufacturing Practice

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

Prepare to meet GMP requirements in the work area

  1. Regulations, codes and guides relevant to the work area are identified
  2. Workplace documentation relevant to work area activities is identified and reviewed to confirm that GMP requirements are met
  3. The required facilities, materials, storage, equipment and personnel are confirmed and available
  4. Operators who have the required competence to perform production/packaging activities to company and GMP standards are identified
  5. Line clearance procedures are carried out
  6. Critical processes are validated according to validation requirements
  7. Procedures to eliminate or control the risk of cross-contamination are followed
Regulations, codes and guides relevant to the work area are identified

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Workplace documentation relevant to work area activities is identified and reviewed to confirm that GMP requirements are met

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

The required facilities, materials, storage, equipment and personnel are confirmed and available

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Operators who have the required competence to perform production/packaging activities to company and GMP standards are identified

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Line clearance procedures are carried out

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Critical processes are validated according to validation requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Procedures to eliminate or control the risk of cross-contamination are followed

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Monitor the observance of GMP in the work area

  1. Work practices conform to GMP requirements
  2. In-process and environmental monitoring is carried out and recorded as required by GMP
  3. Personal hygiene and conduct of personnel in the work area meets GMP requirements
  4. Personnel movement between work areas complies with entry and exit procedures
  5. GMP-related data is recorded to meet workplace reporting requirements
Work practices conform to GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

In-process and environmental monitoring is carried out and recorded as required by GMP

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Personal hygiene and conduct of personnel in the work area meets GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Personnel movement between work areas complies with entry and exit procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

GMP-related data is recorded to meet workplace reporting requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Respond to failures or non-conformances

  1. The scope of failures or non-conformances are defined
  2. Procedures to follow in the event of a failure are documented
  3. Failures are investigated to determine root causes
  4. Risk assessment is conducted
  5. Findings are reported to meet GMP requirements
  6. Procedures are followed to implement and monitor corrective and preventative action
The scope of failures or non-conformances are defined

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Procedures to follow in the event of a failure are documented

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Failures are investigated to determine root causes

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Risk assessment is conducted

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Findings are reported to meet GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Procedures are followed to implement and monitor corrective and preventative action

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Complete work to meet GMP requirements

  1. Processes are reviewed to ensure all procedures are complete
  2. Line logs are reviewed to ensure documentation is complete
  3. End-of-batch procedures are followed
Processes are reviewed to ensure all procedures are complete

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Line logs are reviewed to ensure documentation is complete

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

End-of-batch procedures are followed

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

Evidence Guide

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.

Required Skills and Knowledge

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

Range Statement

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