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FBPPHM3020 — Apply Good Manufacturing Practice requirements

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What an assessment for FBPPHM3020 must cover

48 assessable components: 6 elements (23 performance criteria), 9 performance evidence and 14 knowledge evidence requirements, plus 2 foundation skills. An audit-defensible tool maps every question and task back to these — that mapping is the coverage matrix Auditori generates alongside the assessment.

Elements & performance criteria

1 Identify requirements of GMP related to own work

  • 1.1Locate sources of information on GMP requirements and regulatory obligations of employees relevant to work role from current Australian and other applicable regulatory frameworks for manufacturing pharmaceuticals
  • 1.2Identify GMP requirements for pharmaceutical manufacture tasks
  • 1.3Confirm specific GMP requirements for own work
  • 1.4Identify GMP non-compliant situations and risks to product quality
  • 1.5Alert relevant personnel and take appropriate action according to GMP requirements and workplace procedures

2 Complete workplace documentation to support GMP

  • 2.1Use workplace procedures to identify GMP requirements for documentation
  • 2.2Record required information, calculations and test results according to workplace reporting procedures and GMP requirements
  • 2.3Certify records according to GMP requirements

3 Identify and follow biosecurity requirements

  • 3.1Identify information appropriate to work role relating to biosecurity requirements
  • 3.2Follow workplace biosecurity requirements and responsibilities related to work role

4 Apply GMP requirements when carrying out work activities

  • 4.1Identify common forms of contamination relevant to own work activities
  • 4.2Conduct work according to workplace environmental procedures
  • 4.3Maintain workplace cleanliness and tidiness to meet GMP requirements
  • 4.4Identify and report signs of unacceptable plant, equipment condition or calibration status
  • 4.5Identify GMP requirements for routinely monitoring work area, materials, equipment and product
  • 4.6Complete documentation according to workplace procedures

5 Apply hygiene and entry and exit procedures to meet GMP requirements

  • 5.1Maintain personal hygiene to meet GMP requirements
  • 5.2Carry out hand washing according to best practice hygiene standards
  • 5.3Prepare, use, store and dispose of personal protective equipment and contamination prevention clothing according to GMP requirements and workplace procedures
  • 5.4Comply with area entry and exit procedures when moving around the workplace

6 Participate in improving GMP

  • 6.1Identify processes, practices or conditions which are inconsistent with GMP requirements and report according to workplace procedures
  • 6.2Identify elements of GMP that help improve products and processes
  • 6.3Implement corrective action within level of responsibility

Performance evidence

  • read and interpreted relevant instructions and labels applicable to GMP operations, including pictorial and written signs and instructions
  • followed workplace information relating to GMP responsibilities
  • completed forms and reports according to GMP requirements and workplace procedures
  • recorded calculations and test results
  • identified and responded to: out-of-calibration equipment out-of-specification or unacceptable raw materials, packaging components, final or part processed product
  • maintained workplace cleanliness and tidiness to meet GMP requirements
  • maintained personal hygiene consistent with GMP requirements, including: making team leader or supervisor aware of reportable illness removal of jewellery removal of makeup cleaned and sanitised hands using recognised procedures for: washing with soap and water rubbing with an alcohol-based formulation
  • used personal protective clothing and equipment and contamination prevention clothing according to GMP requirements
  • provided accurate verbal and written descriptions of incidents or situations that did or could have: compromised GMP compliance or product quality provided the potential for product contamination.

Knowledge evidence

  • GMP as a regulatory concept, including regulatory obligations of employees, and the potential implications of non-compliance
  • applicable sections of Australian and other applicable regulatory frameworks relevant to pharmaceutical manufacturing: Therapeutic Goods Act (TGA) Manufacturing Principles Guide to GMP
  • the relationship between GMP and the quality system, including: personnel responsible for designing and managing GMP personal role to maintain GMP the role of internal and external auditors quality procedures quality assurance quality control risk management procedures
  • personal clothing use, storage and disposal requirements and hygiene requirements, including: informing team leader or supervisor of reportable illness removal of jewellery removal of makeup personal clothing and footwear requirements for working in and moving between work areas
  • workplace cleaning standards and responsibilities relating to own work, including: waste collection recycling, safe handling and disposal for different types of waste safe handling and disposal of hazardous waste
  • awareness of common contaminants relevant to the work process, including: microbiological, from materials, equipment, environment and personnel physical, from equipment, environment and personnel chemical, from other products or materials, including cleaning agents
  • quality control methods and procedures, including the purpose of control and the consequence if not controlled
  • properties, handling and storage requirements of raw materials, packaging components and final product
  • GMP requirements for maintaining plant and process equipment
  • GMP requirements for transferring of equipment and material between areas
  • GMP requirements for equipment status labelling
  • documentation systems and procedures, including: recordkeeping to meet both workplace and legal requirements responsibilities for reporting and recording information batch documentation cleaning records training records product and materials traceability procedures controls and methods for ensuring electronic data integrity and paper data integrity significance of certifying and verifying GMP records
  • procedures for responding to out-of-specification or unacceptable process performance or outcomes
  • awareness of controls to protect personnel and the environment from contamination by products and materials.

Foundation skills

  • Reading: Interpret information about GMP compliance requirements in workplace documentation
  • Writing: Record workplace information using appropriate language and in required format

Unit content sourced from training.gov.au — © Commonwealth of Australia, licensed under CC BY 4.0. Auditori is not affiliated with the Department of Employment and Workplace Relations.

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Questions about assessing FBPPHM3020

What does an assessment tool for FBPPHM3020 need to cover?

To satisfy the Principles of Assessment and Rules of Evidence, an assessment for FBPPHM3020 needs to address all 48 unit components: 6 elements with 23 performance criteria, 9 performance evidence requirements, 14 knowledge evidence requirements, and the foundation skills. A coverage matrix mapping each question and task to these components is what an auditor looks for.

How does Auditori generate an assessment tool for FBPPHM3020?

Auditori pulls the current release of FBPPHM3020 from training.gov.au and generates a complete package: candidate assessment, assessor guide with model answers and observation criteria, and a coverage matrix mapping every component. A suitably qualified person then reviews and approves the draft in a built-in workflow — consistent with ASQA's guidance on AI use in VET — before export as branded PDF and editable Word.

Is the first assessment tool really free?

Yes. Every new account includes one free credit — enough to generate the complete assessment tool for FBPPHM3020 — with no card and no subscription required. After that it's pay-as-you-go per unit.

Can I check my existing FBPPHM3020 assessment instead of generating a new one?

Yes — upload your existing assessment or learner guide and Auditori maps it against every element, performance criterion, PE and KE of FBPPHM3020, showing exactly what's covered and what's missing. Mapping costs a quarter of a credit.

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