MSc Pharmaceutical Industrial Advanced Training (PIAT) / Course details

Year of entry: 2020

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

  • 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

This unit is delivered entirely through distance learning. A printed manual consisting of ten chapters is issued to the student on registration and receipt of payment. Each chapter is designed to contain ten hours of assessed learning.

Additional learning activities are directed which, together with the assessment, require 50 hours of self directed learning and assessment.

Knowledge and understanding

  • Self-directed learning.

Practical skills

  • Reflective diary
  • Peer review
  • Self-directed learning.

Transferable skills and personal qualities

  • Group work
  • Work based learning
  • Self-directed learning.

 

Knowledge and understanding

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

Critically analyse, evaluate and, where appropriate, formulate an informed opinion about:

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

Practical skills

  • 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

  • Recognition that the QP is not the font of all knowledge and you require to trust expert knowledge and that not all experts are equal – know who you can trust.
  • The ability to 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.
  • Networking with key stakeholders in own organisation to drive processes forward based on knowledge gained through course participation.
  • The ability to assess current working practices based on knowledge and experience gained and adapt working processes as necessary.
  • The ability to prioritise and effectively manage time to complete work by required deadlines.

Assessment methods

Method Weight
Written exam 70%
Written assignment (inc essay) 30%

Assessment task

Length

How and when feedback is provided

Weighting within unit (if relevant)

 

Assignment

3000 words

Marks and feedback sent by email within 15 working days

30%

Exam

2 hours

Marks sent after exam board

70%

 

 

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 2
Independent study hours
Independent study 148

Teaching staff

Staff member Role
Brian Nisbet Unit coordinator

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