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MSc Pharmaceutical Technology and Quality Assurance

Year of entry: 2022

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Course unit details:
Quality Control

Unit code PHAR61900
Credit rating 15
Unit level FHEQ level 7 – master's degree or fourth year of an integrated master's degree
Teaching period(s) Semester 1
Offered by Pharmacy
Available as a free choice unit? No

Overview

·         Techniques and Instrumentation

§  Volumetric analysis - aqueous and non-aqueous

§  Identification tests, test tube reactions, limit tests

§  Gravimetric analysis

§  Refractometry

§  Melting point

§  Polarimetry

§  Spectroscopy - UV/Visible

§  Spectroscopy – Infra-red (IR)

§  Spectroscopy – Atomic absorption

§  Electrochemistry / pH

§  Particulate measurement, liquids

§  Solid Dose Forms, Physical testing methods (e.g. hardness, friability, disintegration; theoretical only)

§  Dissolution (theoretical only)

§  Thin layer Chromatography (TLC)

§  High-performance liquid chromatography (HPLC)

§  Gas Chromatography

§  Ion separation Chromatography

§  Endotoxin and pyrogen testing (theory)

§  Pharmaceutical microbiology - sterility testing, non-sterile product microbiology, water systems testing, preservative efficacy testing

·      The QC department

§  Control of quality and the role of the quality controller

§  Unlicensed products and “Specials”

§  Involvement in Clinical Trials

o   Governance

o   Ethics

o   Quality Assurance

o   Monitoring

·      Product testing

§  Purchased medicines

§  Raw Materials

§  Final products

·      Medical Gases

§  Range and users of medical gases

§  HTM 02 and permit-to-work system

§  Role of ‘Quality Controller’ in Medical Gas Testing

§  On-site testing

·      Clean room qualification

§  Air quality determination

o   Room over-pressures

o   Viable and non-viable particle counts

o   Air flow

o   Air change rate

·      Statistics

§  Application of statistical methods to sampling and testing methods

Aims

The quality control unit aims to develop students’ knowledge and understanding of the techniques used for analysis of starting materials, packaging components and finished pharmaceutical products.  Students will also be given the knowledge to decide on appropriate analytical methods for specific application and tools to critically evaluate data.

Teaching and learning methods

1.  A teaching block including workshops, practicals and site visits.

 

2.  E-Learning: evidence-based learning supported by course notes, audio lectures and discussion boards

 

Knowledge and understanding

1.      Discuss the role in ensuring the safety of the patient, particularly related to the manufacture of licensed and unlicensed products and Investigational Medicinal Products.

2.      Explain the theory and use of all pharmaceutical microbiological and analytical techniques and instruments in a pharmaceutical quality control laboratory.

3.      Discuss the quality of medicinal products, including raw materials, licensed and unlicensed products, "specials", Investigational Medicinal Products (IMPs), medical and surgical devices and medical gases.

4.      Define cleanroom qualification testing requirments.

5.     Justify the choice of, and apply statistical methods to sampling and testing. 

Intellectual skills

1.      Perform analytical method validation and equipment validation.

2.     Interpret QC data and investigate questionable data/results.

Practical skills

1.      Work within the principles and practice of instruments, equipment and methodology used in pharmacy technical services.

2.      Critically evaluate data and investigate anomalous results.

3.     Identify validation requirements for any changes to processes.

Transferable skills and personal qualities

1.      Project management; taking responsibility for and planning a project from beginning to end.

2.     Selection and use of appropriate methods to find solutions.

Assessment methods

Method Weight
Written exam 100%

Portfolio Video

(Critically reviewed observations/evidence documented against all topics required by portfolio specification.)

Pass/Fail

 

Feedback methods

Provisional marks and feedback for coursework returned within 15 working days.

Exam marks and final marks returned after ratification at exam board. 

Study hours

Scheduled activity hours
Assessment written exam 1.5
Lectures 22
Work based learning 80
Independent study hours
Independent study 46.5

Teaching staff

Staff member Role
Ruth Barnes Unit coordinator

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