Unit 7 Principles of Safe Preparation and Manufacturing of Medicines and Pharmaceutical Products Assignment Brief
| Qualification | Pearson BTEC Level 2 Certificate in the Principles and Practice for Pharmacy Support Staff (603/6166/9) |
| Unit Number | 7 |
| Unit Title | Principles of Safe Preparation and Manufacturing of Medicines and Pharmaceutical Products |
| GLH | 70 |
| Credit | 10 |
| Learning Outcomes | 1. Understand governance requirements for the manufacture of pharmaceutical products
2. Understand the requirements for environmental and personal hygiene within pharmaceutical manufacturing 3. Be able to accurately perform calculations within pharmaceutical preparation and manufacturing 4. Be able to support the processing and manufacturing of pharmaceutical products 5. Understand the quality requirements in manufacturing pharmaceutical products |
Unit Aim
The aim of this unit is to provide learners with the knowledge, understanding and skills to be able to work safely in the preparation of pharmaceutical products within a specialist preparation/manufacturing environment. Learners must be able to accurately perform simple pharmaceutical calculations to support assembly, inprocess checking and preparation of medicines and medicinal products. They should be able to demonstrate a range of techniques used to produce products safely and accurately.
In this unit you will develop your understanding of Good Manufacturing Practice and the legislation and Standard Operating Procedures that govern all areas relating to the preparation and manufacture of medicines.
You will gain an understanding of the different types of manufacturing, the range of environments used for pharmaceutical manufacturing and their individual requirements. You will understand the importance of hygiene and the sources of different types of contamination and the potential consequences linked to these areas.
You will also be able to demonstrate your ability to perform accurate calculations and complete the different types of documentation required in each of the manufacturing environments for all the different processes to ensure that a valid audit trail is maintained.
Learning Outcomes and Assessment Criteria
| Learning outcomes | Assessment criteria | ||
| 1 | Understand governance requirements for the manufacture of pharmaceutical products | 1.1 | Describe legal and current organisational guidelines that apply to the manufacture of pharmaceutical products |
| 1.2 | Describe how Good Manufacturing Practice (GMP) applies to the manufacture of pharmaceutical products | ||
| 1.3 | Describe the difference between batch manufacturing and preparing a product for an individual patient | ||
| 1.4 | Explain the importance of following Standard
Operating Procedures in relation to the manufacture of pharmaceutical products |
||
| 1.5 | Explain the limitations of own role and when to refer to an appropriate person | ||
| 2 | Understand the requirements for environmental and personal hygiene within pharmaceutical manufacturing | 2.1 | Describe the different types of environment used in the manufacture of pharmaceutical products |
| 2.2 | Describe how these environments are monitored and
suitably maintained for the manufacture of pharmaceutical products |
||
| 2.3 | Explain the different sources of contamination which affect the manufacture of pharmaceutical products | ||
| 2.4 | Outline the impact of contamination within pharmaceutical manufacturing | ||
| 2.5 | Explain the personal hygiene requirements and why these are important | ||
| 3 | Be able to accurately perform calculations within pharmaceutical preparation and manufacturing | 3.1 | Explain the importance of performing accurate calculations |
| 3.2 | Demonstrate how to calculate quantities | ||
| 4 | Be able to support the processing and manufacturing of pharmaceutical products | 4.1 | Demonstrate adherence to relevant gowning up procedures and personal hygiene requirements |
| 4.2 | Identify the different types of pharmaceutical products | ||
| 4.3 | Demonstrate the different manufacturing techniques used to make pharmaceutical products | ||
| 4.4 | Outline the different methods of sterilisation | ||
| 4.5 | Demonstrate how to maintain the correct storage conditions for manufactured pharmaceutical products | ||
| 4.6 | Demonstrate how to clean and decontaminate equipment and preparation area | ||
| 4.7 | Demonstrate the process for the safe handling and disposal of hazardous waste relating to the manufacture of pharmaceutical products | ||
| 5 | Understand the quality requirements in manufacturing pharmaceutical products | 5.1 | Outline the packaging and labelling requirements for manufactured pharmaceutical products |
| 5.2 | Identify the documentation used in the manufacture of pharmaceutical products | ||
| 5.3 | Demonstrate quality assurance and quality control systems in relation to manufacturing pharmaceutical products | ||
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