FBP40518 Certificate IV in Pharmaceutical Manufacturing


FBP40518 Certificate IV in Pharmaceutical Manufacturing reflects the skills and knowledge for team leaders, supervisors and specialist technical roles within pharmaceutical manufacturing environments. The qualification includes technical skills, problem solving and supervisory skills to operate, monitor and improve the performance of pharmaceutical manufacturing systems, processes and team members.

Work must comply with good manufacturing practice, health and safety and environmental regulations and legislation that apply to the workplace.


There are no stated entry requirements for FBP40518 Certificate IV in Pharmaceutical Manufacturing


36 weeks based on customisation with employer requirements but may vary based on:

  • Customisation and employment outcome for elective units of competency selected
  • Employee availability release time per week for work place training


Graduates of this qualification may apply for a role such as a Pharmaceutical Production Supervisor


FBP40518 Certificate IV in Pharmaceutical Manufacturing offers a pathway for those who work in pharmaceutical manufacturing environments and who progress from Certificate III qualifications. The work outcomes at this level focus on team leadership /quality production type roles.

The Certificate IV qualification reflects the role of individuals to undertake work in varied contexts using a broad range of specialised knowledge and skills.  Certificate IV is suitable for senior workers and technicians who supervise or lead teams. Certificate IV also serves as a pathway for further learning.

Pathways into the qualification:

A pathway for candidates considering this qualification include:

  • FBP30821 Certificate III in Pharmaceutical Manufacturing

Pathways from the qualification:

After successfully achieving FBP40518 Certificate IV in Pharmaceutical Manufacturing, candidates may develop their pathway to relevant further studies in pharmaceutical manufacturing at the Diploma or higher-level qualification


FBP40518 Certificate IV in Pharmaceutical Manufacturing consists of sixteen (16) units of competency:

  • 8 core units, plus
  • 8 elective units
Unit CodeUnit TitleC/E
BSBSMB407Manage a small teamCore
BSBWHS401Implement and monitor WHS policies, procedures and programs to meet legislative requirementsCore
FBPPHM4001Monitor and maintain good manufacturing practice requirementsCore
FBPPHM4002Prepare and review workplace documentation to support good manufacturing practice requirementsCore
FBPPHM4003Facilitate contamination controlCore
FBPPHM4005Participate in validation of pharmaceutical manufacturing processesCore
FBPPHM4006Respond to non-conformanceCore
FBPPPL3006Report on workplace performanceCore
FBPOPR3005Operate interrelated processes in a production systemElective
FBPPHM3002Operate a pharmaceutical production processElective
FBPPHM3004Clean and sanitise facilities and equipmentElective
FBPPHM4004Participate in change control proceduresElective
MSS402080Undertake root cause analysisElective
BSBLDR411Demonstrate leadership in the workplaceElective
BSBOPS402Coordinate Business operational planElective
BSSTR402Implement continuous improvementElective


Pivotal Education understands the philosophy that training should be tailored to suit individual client’s business objectives. Therefore, Pivotal Education can customise the elective units of competency to suit prospective client’s specific industry requirements. Customisation may result in changes to the duration required to complete the qualification.


Pivotal Education delivers in the following locations:

  • Workplace – employees can benefit from training and assessment in the work place and particularly in their work area to make the experience meaningful and relevant to vocational outcomes
  • Pivotal Education – small classes can benefit from training and assessment at Pivotal Education’s own meeting room.
  • External Venues – Pivotal Education arranges meeting rooms and simulated environments where required to deliver and assess part of a qualification or single unit of competency


Training is delivered through blended flexible work-based training and assessment including group sessions, one to one delivery and work station observation. This may include:

  • Face to Face instruction in a designated quiet area
  • Practical demonstration/observation in the work station area as required
  • Mentoring
  • Integrated online learning through Canvas
  • Component of self-paced study to research and prepare for assessments
  • Workplace supervision


Students will be assessed using relevant assessment methods for each unit which includes but is not limited to the following:

  • Short Answer Assessment Questions
  • Practical demonstration/ observation
  • Project Task
  • Portfolio of evidence – workplace documents
  • Third Party report *
  • indicates essential evidence of completing a work-based training


Students that successfully complete all 16 units of competency as stated in the Course Structure will be issued with FBP40518 Certificate IV in Pharmaceutical Manufacturing by Pivotal Education. This qualification is recognised nationally under the Australian Qualifications Framework (AQF).

Students that complete some but not all of the units of competency as stated in the Course Structure may be issued with a Statement of Attainment by Pivotal Education. It will identify only those units of competence that have been completed as part of the qualification and recognised nationally under the AQF.


Students are provided with the following:

  • Student guides
  • Student assessments


Please refer to Pivotal Education website at https://www.pivotal.edu.au/ for details of the following conditions of enrolment:

  • Student entry support
    • Language literacy numeracy
    • Recognition of prior learning
    • Credit transfer
  • Eligibility
  • Applications
  • Verification of documentation
  • Deferral of commencement
  • Personal and contact details
  • Unique student identifier
  • Fee payments
  • Refund and cancellation
  • Complaints
  • Termination
  • Consumer rights


  1. Students who give notice to cancel their enrolment more than 10 days prior to the commencement of a program will be entitled to a full refund of fees paid
  2. Students who give notice to cancel their enrolment less than 10 days prior to the commencement of a program will be entitled to a 75% refund of fees paid
  3. The amount retained (25%) by Pivotal Education is required to cover the costs of staff and resources which will have already been committed based on the student’s initial intention to undertake the training
  4. Students who cancel their enrolment after a training program has commenced will not be entitled to a refund of fees.


Students may access the following website for all essential information regarding this Qualifications:


All completed Enrolment Forms go directly to RTO Enrolments, Pivotal Education via email at any time. Enrolment forms in person will be accepted during business hours. Refer to RTO details chart below for contact details and business hours.


RTO Name Pivotal Education
Address Level 8, 80 George Street Parramatta NSW 2150
Telephone 02 9687 9299
Fax 02 9687 9499
Email training@pivotal.com.au
Website: https://www.pivotal.edu.au/
RTO ID: 90272
Business Hours Monday to Friday – 8:30am to 5:30pm
After Hours Number 1800 664 527


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