Unit of competency Outline

Date retreived
21/07/2026 11:24 PM AWST

Whilst all efforts are made to provide accurate and timely information from the relevant source/documentation, please be aware that the information supplied may not be the most current version. The accuracy of the detail has not been confirmed by the Department and therefore should not be relied upon without first confirming the contents.

Apply Good Manufacturing Practice procedures

Apply Good Manufacturing Practice procedures

Unit of competency
National Code
FDFPH2001A
State Code
D4676
TGA Status
Replaced
DTWD Status
Replaced
Current Release Number
1.00
Current Release Date
31/01/2011
View on TGA
State Implementation and Classification
Approved Date
31/07/2014
Field of Education
080317 - Quality Management
Original Release Date
31/07/2014
Nominal Hours
54
Description
This unit of competency covers the skills and knowledge required to comply with relevant Good Manufacturing Practice (GMP) codes through the implementation of workplace GMP and quality procedures.
Notes
Elements and Performance Criteria
1. Identify requirements of GMP related to own work
  • 1.1. Sources of information on GMP requirements are located
  • 1.2. GMP requirements and responsibilities related to own work are identified
2. Ensure that personal hygiene and conduct meets GMP requirements
  • 2.1. Personal hygiene meets GMP requirements
  • 2.2. Clothing is prepared, used, stored and disposed of according to GMP and workplace procedures
  • 2.3. Personal movement around the workplace complies with area entry and exit procedures
3. Implement GMP requirements when carrying out work activities
  • 3.1. Work area, materials, equipment and product are routinely monitored to ensure compliance with GMP requirements
  • 3.2. Raw materials, packaging components and product are handled/stored according to GMP and workplace procedures
  • 3.3. Workplace procedures to control resource allocation are followed to meet GMP requirements
  • 3.4. Common forms of contamination are identified and appropriate control measures are followed according to GMP requirements
  • 3.5. The workplace is maintained in a clean and tidy order to meet GMP housekeeping standards
  • 3.6. Work is conducted in accordance with workplace environmental guidelines
  • 3.7. Out-of-specification or contaminated materials, packaging components/consumables and product, waste and recyclable materials are handled and disposed of according to GMP requirements and workplace procedures
  • 3.8. Signs of unacceptable plant or equipment condition are identified and reported
4. Participate in improving GMP
  • 4.1. Processes, practices or conditions which could result in non-compliance with GMP are identified and reported according to workplace reporting requirements
  • 4.2. Corrective action is implemented within level of responsibility
  • 4.3. GMP issues are raised with designated personnel
5. Complete workplace documentation to support GMP
  • 5.1. Documentation and recording requirements are identified
  • 5.2. Information is recorded according to workplace reporting procedures to meet GMP requirements
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.
Policies and procedures
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
signs of pest infestation
Legislative requirements
Legislative requirements are typically reflected in procedures and specifications. Legislation relevant to this industry includes:
relevant GMP codes
the Therapeutic Goods Act
other legislation and codes relevant to product and market
legislation relating to environmental management, occupational health and safety (OHS), anti-discrimination and equal opportunity
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 related to GMP together with a range of commercial production/packaging equipment and activities typical of commercial manufacturing businesses and that 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 to ensure that the skills and knowledge of this unit are routinely applied to the work environment.
Assessment must require the candidate to identify and demonstrate responsibilities for implementation of GMP in the workplace.

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 2 and could be assessed concurrently with other operational units.

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.
Replaces
State Code National Code Title Type
W1263 FDFPHGMP2B Implement Good Manufacturing Practice procedures Unit of competency
Replaced By
State Code National Code Title Type
OAL95 FBPPHM3001 Apply Good Manufacturing Practice requirements Unit of competency