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Evidence Guide: FDFPH3001A - Monitor and maintain Good Manufacturing Practice procedures

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

 

FDFPH3001A - Monitor and maintain Good Manufacturing Practice procedures

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

Ensure others in the work area are able to meet GMP requirements

  1. Relevant clothing and equipment appropriate to work requirements is available, functional and correctly fitted
  2. Advice on GMP responsibilities and procedures is accessible and clearly explained
  3. GMP control measures used in the work area can be identified by those in the work area
  4. Mentoring and coaching support is available to support individuals/groups to implement GMP and related procedures
  5. Training needs are identified and addressed within level of responsibility
Relevant clothing and equipment appropriate to work requirements is available, functional and correctly fitted

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Advice on GMP responsibilities and procedures is accessible and clearly explained

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

GMP control measures used in the work area can be identified by those in the work area

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Mentoring and coaching support is available to support individuals/groups to implement GMP and related procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Training needs are identified and addressed within level of responsibility

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Monitor personal hygiene and conduct of team members in the work area

  1. Personal hygiene of work team meets GMP requirements
  2. Clothing is prepared, used, stored and disposed of according to GMP and workplace procedures
  3. Personal movement around the workplace complies with area entry and exit procedures
Personal hygiene of work team meets GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Clothing is prepared, used, stored and disposed of according to GMP and workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Personal movement around the workplace complies with area entry and exit procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Monitor implementation of GMP requirements in the work area

  1. GMP procedures in the work area are clearly defined, documented and followed
  2. Non-compliance from identified procedures is reported and addressed within level of responsibility
  3. Signs of unacceptable plant or equipment condition are identified and reported
  4. Personal behaviour provides a role model to others to support implementation of GMP workplace policies and procedures
  5. Workplace procedures to control resource allocation are followed to meet GMP requirements
  6. GMP non-conformance is identified and reported according to workplace procedure
  7. GMP information is recorded to meet workplace reporting requirements
  8. The workplace is maintained in a clean and tidy order to meet GMP housekeeping standards
GMP procedures in the work area are clearly defined, documented and followed

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Non-compliance from identified procedures is reported and addressed within level of responsibility

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Signs of unacceptable plant or equipment condition are identified and reported

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Personal behaviour provides a role model to others to support implementation of GMP workplace policies and procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Workplace procedures to control resource allocation are followed to meet GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

GMP non-conformance is identified and reported according to workplace procedure

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

GMP information is recorded to meet workplace reporting requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

The workplace is maintained in a clean and tidy order to meet GMP housekeeping standards

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Participate in validation processes

  1. Validation procedures are followed to GMP requirements
  2. Issues arising from validation are raised with designated personnel
  3. Validation procedures are documented to meet GMP requirements
Validation procedures are followed to GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Issues arising from validation are raised with designated personnel

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Validation procedures are documented to meet GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Take corrective action in response to GMP non-compliance

  1. Processes, practices or conditions which could result in non-compliance with GMP are identified and reported according to workplace reporting requirements
  2. Corrective action is taken in accordance within level of responsibility
  3. GMP issues are raised with designated personnel
Processes, practices or conditions which could result in non-compliance with GMP are identified and reported according to workplace reporting requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Corrective action is taken in accordance within level of responsibility

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

GMP issues are raised with designated personnel

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Maintain and improve GMP in the work area

  1. Processes or conditions which could result in non-conformance with GMP are identified, reported and corrected within level of responsibility
  2. Matters raised relating to GMP are promptly resolved and/or referred to appropriate personnel
  3. Effectiveness of control measures are monitored within level of responsibility
  4. Others in the work area are advised of GMP matters relevant to work role
  5. Workplace records and documents are maintained in accordance with workplace procedures and GMP requirements
Processes or conditions which could result in non-conformance with GMP are identified, reported and corrected within level of responsibility

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Matters raised relating to GMP are promptly resolved and/or referred to appropriate personnel

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Effectiveness of control measures are monitored within level of responsibility

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Others in the work area are advised of GMP matters relevant to work role

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Workplace records and documents are maintained in accordance with workplace procedures and GMP requirements

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 workplace context. A simulated environment must provide access to a typical range of production equipment, procedures and related documentation, records and related resources to meet the requirements of the Therapeutic Goods Act.

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

GMP is an ongoing and routine aspect of work responsibilities. Assessors should collect sufficient evidence that the skills and knowledge of this unit are routinely applied to the work environment.

Evidence of ability to:

identify the components of GMP and related roles and responsibilities as they relate to work role

provide a role model to others in the workplace to support implementation of GMP

participate in GMP processes within level of responsibility. Examples of these processes include validation, line clearance, equipment calibration, change management, maintenance of documentation. This would typically be undertaken in a team context.

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 questioning and workplace observation. It may involve additional collection of evidence from a range of sources, such as third party reports, workplace documentation relating to GMP, and real or simulated workplace contexts.

Method of assessment

This unit is a core requirement for all pharmaceutical operators at AQF 3 and could be assessed concurrently with other units relating to process improvement and supporting others, such as:

FDFPPL3001A Participate in improvement processes

FDFPPL3003A Support and mentor individuals and groups

FDFPPL3005A Participate in an audit process

FDFTEC3001A Participate in a HACCP team.

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:

communicate information on GMP requirements to others in the work area, including demonstration of two-way communication, such as active listening and constructive response to feedback

access and use document management systems

model personal conduct and work activities to meet requirements of GMP

monitor that data is recorded to meet GMP recording requirements within level of responsibility

provide guidance and support to others to in the work area to implement GMP responsibilities within level of responsibility

determine action required to respond to GMP non-compliance within level of responsibility

participate in improvement processes, such as investigating actual and potential GMP non-compliance

participate in and/or review practices and procedures to prevent or minimise the likelihood of unacceptable performance

work cooperatively within a culturally diverse workforce

Required knowledge

Knowledge of:

the role of GMP in preventing contamination, its relationship to legal requirements of pharmaceutical manufacturers and potential implications of non-compliance

GMP arrangements in the workplace, including relevant GMP codes of practice and related workplace policies and procedures to implement these responsibilities

role of effective communication and consultation processes

workplace training and development system and responsibilities

role of quality assurance and related system components and activities in GMP

procedures followed to investigate contamination events and performance improvement processes

personal clothing and footwear requirements for working in and/or moving between work areas

personal clothing use, storage and disposal requirements

current technical and process knowledge required to monitor GMP and participate in investigating GMP non-compliance within level of responsibility, including common microbiological, physical and chemical contaminants, conditions under which types of contamination, e.g. cross-contamination, are likely to occur, related control methods and validation procedures and responsibilities

control methods and procedures used in the work area to maintain GMP, including the purpose of control, the consequences if not controlled and the method of control where relevant

methods used to monitor process control, purpose and requirements of validation procedures and purpose of equipment calibration

recall and traceability procedures relevant to work area

line clearance procedures and responsibilities

properties, handling and storage requirements of raw materials, packaging components and final product handled and used in the work area

standards for materials, equipment and utensils used in the work area

procedures for responding to out-of-specification or unacceptable performance/outcomes, including procedures for identifying and isolating or quarantining materials or product of unacceptable quality within level of responsibility

documentation system and procedures, including record keeping to meet both company and legal requirements, procedures for developing and/or reviewing workplace procedures and document control systems used in the workplace and responsibilities for reporting and recording information

housekeeping requirements and responsibilities relating to own work, and where relevant, use and storage of housekeeping/cleaning equipment

waste collection, recycling, handling and disposal, including handling/disposal requirements for different types of waste, such as hazardous waste where relevant

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.

Work activities

Work activities are carried out according to company policies and procedures, regulatory and licensing requirements, legislative requirements and industrial awards and agreements

Unacceptable plant or equipment condition

Unacceptable plant or equipment condition can include:

damage to plant or equipment

failure of cleaning regime

equipment requiring calibration

signs of pest infestation

Validation

Typically validation is the responsibility of the quality department. A person at this level would be expected to understand the purpose and responsibilities for validation and may be required to participate in validation processes as part of a team

Legislative requirements

Legislative requirements are typically reflected in procedures and specifications. Legislation relevant to this industry includes:

relevant, Good Manufacturing Practice (GMP) codes

the Therapeutic Goods Act and other legislation and codes relevant to product and market

legislation relating to environmental management, occupational health and safety (OHS), anti-discrimination and equal opportunity

Quality assurance and related system components and activities

Quality assurance and related system components and activities can include but is not limited to:

process control

deviation investigation and analysis

corrective and preventative action systems

sampling plans

change control

validation procedures

line clearance

system documentation requirements

audit processes