MSc Pharmaceutical Industry Advanced Training (PIAT) / Course details

Year of entry: 2022

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Course unit details:
Quality Control Laboratory Testing (PIAT 13)

Unit code PHAR70130
Credit rating 15
Unit level FHEQ level 7 – master's degree or fourth year of an integrated master's degree
Teaching period(s) Variable teaching patterns
Offered by Pharmacy
Available as a free choice unit? No

Overview

This unit covers the sampling, specifications, physical, chemical, spectroscopic, and chromatographic test methods, packaging component testing, microbiological testing, environment, water, steam and gasses, validation and out of specification results. 

Aims

The unit aims to enable students to; 

  • Acquire and develop an advanced knowledge and in depth understanding of the expertise and of the role of analytical chemists.
  • Acquire and develop the advanced skills to make an effective contribution to managing quality control laboratory testing in line with key source documents, eg BP/EP/USP/JP/Orange Guide/ICH/FDA/PICS/WHO.
  • Demonstrate awareness of areas of analysis and problems related to the role of the QP.
  • Identify their own learning needs, develop themselves as critically reflective practitioners and advance their own learning to sustain continuing professional development, and work at the forefront of good lab practice in line with GMP standards.
  • Recognise roles and support functions of experts in laboratory practice.
  • Critically evaluate literature, theories and methodologies and apply regulatory founded approaches to quality control laboratory testing.

 

Teaching and learning methods

Students are provided with the learning material in soft copy form. The learning material comprises 12 chapters covering all the key areas of quality control laboratory testing. Each chapter contains a number of exercises for students to check their learning as they progress through the unit. A reference list of further reading is provided at the end of the unit allowing the student to investigate the subject area more deeply, and the unit tutor is available to answer queries and provide guidance as required. The face-to-face workshop at the annual workshop event explores key areas of the unit through a range of hands-on exercises and practical demonstrations.

 

Knowledge and understanding

Students will be able to:

Demonstrate an advanced knowledge and detailed understanding of:

  • sampling;
  • specifications;
  • physical, chemical, spectroscopic and chromatographic test methods;
  • packaging component testing;
  • microbiological testing;
  • environment, water, steam and gases;
  • validation and out of specification results.

Demonstrate an ability to evaluate presented analytical data to determine its validity with reference to batch release within the QP process.

Intellectual skills

Students will be able to critically analyse, evaluate and, where appropriate, formulate an informed opinion about:

  • analytical methodologies;
  • effectiveness of current systems and processes.

Practical skills

Students will be able to: 

  • Analyse qualitative and quantitative data to determine their strength and validity in relation to the analytical laboratory and the tests performed.
  • Complete practical exercises to demonstrate an understanding of the application of knowledge derived from the course material.
  • Carry out constructive peer review.
  • Engage in critically reflective practice as a process of continuous personal development.

Transferable skills and personal qualities

Students will be able to:

  • Recognise that the QP is not the font of all knowledge and expert knowledge may be required, and that not all experts are equal
  • Critique information from a range of sources to formulate opinions
  • Set up and conduct quality control in laboratory testing in accordance with legislative requirements, demonstrating high level knowledge on a process-driven approach
  • Network with key stakeholders in own organisation to drive processes forward based on knowledge gained through course participation
  • Assess current working practices based on knowledge and experience gained and adapt working processes as necessary
  • Prioritise and effectively manage time to complete work by required deadlines

Assessment methods

Method Weight
Written assignment (inc essay) 100%

Assessment task

Length

How and when feedback is provided

Weighting within unit (if relevant)

 

Assignment

3000 words

Feedback returned by email within 15 working days.

100%

 

Feedback methods

Feedback returned by email within 15 working days.

Study hours

Independent study hours
Independent study 150

Teaching staff

Staff member Role
Nigel Richardson Unit coordinator

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