Qualification Outline
22/07/2026 4:58 AM 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.
Certificate IV in Pharmaceutical Manufacturing
Certificate IV in Pharmaceutical Manufacturing
FBP40518
BEE8
Replaced
Replaced
National Endorsed, State Implementation and Classification
Releases
| Release Version | Release Date | TGA Status | DTWD Status |
|---|---|---|---|
| 1.00 | 18/12/2018 | Current | Approved |
Description
This qualification 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.
No occupational licensing, legislative or certification requirements apply to this qualification at the time of publication.
Schedule
Packaging Rules
To achieve this qualification, competency must be demonstrated in:- sixteen (16) units of competency:
- eight (8) core units, plus
- eight (8) elective units.
Elective units must ensure the integrity of the qualifications’ Australian Qualification Framework (AQF) alignment and contribute to a valid, industry-supported vocational outcome. The electives are to be chosen as follows:
- four (4) must be from group A
- four (4) from the remaining units listed in groups A or B, or any currently endorsed Training Package or accredited course packaged at Certificate III, Certificate IV or Diploma, with no more than two (2) units packaged at Certificate III or Diploma.
Please refer to training.gov.au for prerequisite requirements.
1. Core Units
All eight (8) units must be completed.
| State Code | National Code | Title | Hours | Type |
|---|---|---|---|---|
| OAN17 | FBPPHM4003 | Facilitate contamination control | 40 | Unit of competency |
| AUL17 | BSBWHS401 | Implement and monitor WHS policies, procedures and programs to meet legislative requirements | 40 | Unit of competency |
| AUK88 | BSBSMB407 | Manage a small team | 40 | Unit of competency |
| OAM08 | FBPPHM4001 | Monitor and maintain Good Manufacturing Practice requirements | 80 | Unit of competency |
| OAM58 | FBPPHM4005 | Participate in validation of pharmaceutical manufacturing processes | 40 | Unit of competency |
| OAO17 | FBPPHM4002 | Prepare and review workplace documentation to support Good Manufacturing Practice requirements | 60 | Unit of competency |
| OAM22 | FBPPPL3006 | Report on workplace performance | 35 | Unit of competency |
| OAN30 | FBPPHM4006 | Respond to non-conformance | 60 | Unit of competency |
2. Group A Elective Units
At least four (4) units must be completed.
Please refer to the packaging rules for the full details of available options.
3. Group B Elective Units
Up to four (4) units may be completed.
Please refer to the packaging rules for the full details of available options.
Replaces
| State Code | National Code | Title | Type |
|---|---|---|---|
| S774 | FDF40210 | Certificate IV in Pharmaceutical Manufacturing | Qualification |
Replaced By
| State Code | National Code | Title | Type |
|---|---|---|---|
| BHP6 | FBP40522 | Certificate IV in Pharmaceutical Manufacturing | Qualification |
No information
Entry Requirements
There are no entry requirements for this qualification.
Traineeships and Apprenticeships