Open Awards
Level 3
QN: 603/3312/1
Curriculum Active
Open Awards Level 3 Diploma in the Principles of Aseptic Pharmaceuticals Processing (RQF)
Official qualification regulated by Ofqual, awarded by Open Awards. Classified as a Occupational Qualification. Total guided learning hours: 368 hours.
Qualification Level
Level 3
Awarding Body
Open Awards
Syllabus Units
10 Units
Guided Hours
368 hrs
Instant access to interactive lessons, quizzes, and spaced revision.
Course Syllabus & Study Modules
Complete breakdown of verified curriculum topics and learning objectives.
1
Aseptic Manufacture and Preparation Processes
Verified
Key Learning Objectives:
- Understand the principles of practice for Aseptic manufacture and preparation.
- Understand the process of prescription verification for unlicensed Aseptic preparation.
- Understand work area start-up checks .
- Understand the organisational transfer process.
- Understand the importance of reconciliation of labels, materials and packaging in Aseptic Pharmaceuticals.
- Know how to dismantle, clean, decontaminate equipment and the work area correctly.
- Know how to dispose of waste and cleaning materials.
- Understand the causes and consequences of deviations form standard operational procedures.
- Understand problem solving techniques in Aseptic Pharmaceuticals
2
Clean Room Design and Behaviours
Verified
Key Learning Objectives:
- Understand the principles of the design and construction of Clean Rooms.
- Understand the Standard Operating Procedures (SOP) for the maintenance of Clean Rooms.
- Understand Clean Room behaviours, procedures and professional practices.
3
Documentation in Aseptic Processing
Verified
Key Learning Objectives:
- Understand document management in aseptic processing.
- Understand documentation used in aseptic processing.
- Understand how to produce and use aseptic processing documentation.
4
Health, Safety and Reducing Risk in Aseptic Pharmaceuticals
Verified
Key Learning Objectives:
- Understand Health and safety legislation in aseptic processing.
- Understand own roles and responsibilities in relation to health and safety.
- Know how to reduce risk in the workplace.
5
Legislation, Regulations and Standards in Aseptic Pharmaceuticals
Verified
Key Learning Objectives:
- Understand legislation and regulations related to the manufacture of aseptic pharmaceuticals.
- Understand standards related to the manufacture of aseptic pharmaceuticals.
- Understand guidance related to the manufacture of aseptic pharmaceuticals.
- Know about Good Manufacturing Practice (GMP) in relation to aseptic processing.
- Know about Good Clinical Practice (GCP) in relation to aseptic processing.
- Understand how own organisation responds to changes to regulations and legislation related to aseptic pharmaceuticals.
6
Maintenance and Calibration in Aseptic Pharmaceuticals
Verified
Key Learning Objectives:
- Understand the requirements for maintenance and calibration of facilities and equipment.
- Understand the procedures for handover of the processes for maintenance in Aseptic Pharmaceuticals.
- Understand responsibilities and limitations of own role relating to maintenance and calibration.
7
Quality Management in Aseptic Pharmaceuticals
Verified
Key Learning Objectives:
- Understand Quality Management in Aseptic processing.
- Understand how to maintain product quality through the Pharmaceutical Quality System.
- Understand Change Management.
- Understand the impact of errors and/or deviations in Aseptic processing.
- Understand Quality Control (QC) in the context of Quality Assurance.
8
Roles, Responsibilities and Professional Development in Aseptic Pharmaceuticals
Verified
Key Learning Objectives:
- Understand the different roles related to aseptic services.
- Understand the environment in which the aseptic service operates.
- Understand the skills, knowledge and behaviours required for own role.
- Understand continuous improvement related to own role.
- Understand professional responsibilities of own roles.
9
Science in Aseptic Processing
Verified
Key Learning Objectives:
- Understand the basics of chemistry.
- Understand the basics of Pharmaceutics and Formulation.
- Understand the basics of Radio Pharmacy.
- Understand the basics of Materials Science.
- Understand the basic structure of Biological Chemicals.
- Understand human Anatomy and Physiology.
- Understand the basics of Clinical Pharmacy.
- Understand the basics of Microbiology.
10
Stock Management in Aseptic Pharmaceuticals
Verified
Key Learning Objectives:
- Understand stock management in Aseptic processing.
- Understand how to safely store stock for Aseptic Pharmaceuticals.
- Understand how to issue stock in Aseptic Pharmaceuticals.
Regulatory & Verification Details
- Qualification Number (QN)
- 603/3312/1
- Regulated Status
- Available to learners
- Awarding Body
- Open Awards
- Qualification Type
- Occupational Qualification
- Operational Start
- Jul 2018