Assessment Requirements for FBPPHM3020 Apply Good Manufacturing Practice requirements

Release: 1

Assessment Requirements for FBPPHM3020 Apply Good Manufacturing Practice requirements

Modification History

Release	Comments
Release 1	This version released with FBP Food, Beverage and Pharmaceutical Training Package Version 7.0.

Performance Evidence

An individual demonstrating competency must satisfy all of the elements and performance criteria in this unit.

There must be evidence that the individual has applied Good Manufacturing Practice (GMP) requirements, and demonstrated each of the following points on one or more occasions:

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

An individual must be able to demonstrate the knowledge required to perform the tasks outlined in the elements and performance criteria of this unit. This includes knowledge of:

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.

Assessment Conditions

Assessment of the skills in this unit of competency must take place under the following conditions:

physical conditions:

a pharmaceutical manufacturing workplace or an environment that accurately represents workplace conditions

resources, equipment and materials:

personal protective equipment and contamination prevention clothing

alcohol based hand cleanser

soap and water

pharmaceutical production and packaging equipment

specifications:

GMP requirements

workplace reporting procedures

workplace procedures related to GMP

workplace biosecurity requirements

workplace environmental procedures.

Assessors of this unit must satisfy the requirements for assessors in applicable vocational education and training legislation, frameworks and/or standards.

Links

Companion Volumes, including Implementation Guides, are available at VETNet: - https://vetnet.gov.au/Pages/TrainingDocs.aspx?q=78b15323-cd38-483e-aad7-1159b570a5c4