Overview
Qualification Grading Type
Graded
Grade Descriptors
- GD1-Understanding the subject
- GD2-Application of knowledge
- GD4-Use of information
- GD5-Communication and presentation
- GD7-Quality
This unit is expiring
The expiry date of this unit is 31/07/2024.
Unit Learning Outcomes
1
Understand the legislation and guidelines related to the manufacture of pharmaceuticals.
Assessment Criteria
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1.1
Summarise the legislation and guidelines related to the manufacture of pharmaceutical products.
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1.2
Explain how to manage health and safety responsibilities in a manufacturing environment.
2
Know about the environment and equipment required to manufacture pharmaceuticals.
Assessment Criteria
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2.1
Explain the importance of basic environmental and personal hygiene in the manufacture of pharmaceuticals.
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2.2
Analyse the potential consequences of different sources of contamination when manufacturing pharmaceuticals.
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3.3
Explain the difference between sterile and non-sterile manufacturing, with reference to the different methods used.
3
Understand how medicines are manufactured.
Assessment Criteria
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3.1
Summarise the documentation required when manufacturing medicines, including labelling and packaging.
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3.2
Analyse methods of waste disposal in the pharmaceutical manufacturing process, including hazardous waste.
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3.3
Explain principles of safe storage and supply of manufactured products.
4
Understand the principles of quality assurance and quality control required when manufacturing medicines.
Assessment Criteria
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4.1
Explain the difference between quality control and quality assurance in a manufacturing environment.
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4.2
Explain how manufactured products are tested.
5
Understand the aseptic preparation of pharmaceutical products.
Assessment Criteria
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5.1
Explain the importance of validation and record keeping within pharmaceutical manufacturing processes.
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5.2
Explain the importance of quarantine in pharmacy manufacturing.
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5.3
Discuss the types of products made by aseptic units.