MSc Pharmaceutical Industry Advanced Training (PIAT) / Course details

Year of entry: 2021

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Course unit details:
Pharmaceutical Packaging (PIAT 10)

Unit code PHAR71100
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 includes legislation and consumer aspects, the relevant properties of widely used materials, and packaging of sterile products and devices. Storage and transport, testing of packages, product security and the packaging line are also explained. 

Aims

This unit deals with the packaging of pharmaceutical products. On completion of this module, you should have a clear picture of:

  • the role of the pharmaceutical packaging technologist;
  • how the major packaging media are used in our industry;
  • the scope of national and international legislation and regulations that influence the selection and use of packaging materials.

Teaching and learning methods

Students are provided with the learning material in soft copy form. The unit comprises 15 units covering the all the key areas of pharmaceutical packaging. Each unit contains a number of exercises together with suggested answers for students to check their learning as they progress through the unit. Reference lists of further reading are provided within the unit text, 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 a comprehensive knowledge of all major packaging methods/materials and their appropriate use

  • Give an overview of the pharmaceutical packaging operation, activities and material selection process, in order to deliver medicine to patients, in a compliant manner.

Intellectual skills

Students will be able to critically analyse, evaluate and where appropriate formulate an informed opinion about:
•    Pharmaceutical packaging approaches and techniques 
•    Criteria for the selection of packaging materials for pharmaceutical products
 

Practical skills

Students will be able to:

•    Complete practical exercises to demonstrate an understanding of the application of knowledge derived from the course material
•    Engage in critically reflective practice as a process of continuous personal development
•    Network with key stakeholders in own organisation to drive processes forward based on knowledge gained through course participation
 

Transferable skills and personal qualities

Students will be able to:

  • Understand the high level detail of what is required to deliver medicines to patient in a safe and compliant manner, from a packaging perspective.

  • Understand packaging material selection, equipment required and regulatory requirements.

Assessment methods

Method Weight
Written assignment (inc essay) 100%

Feedback methods

Feedback returned by email within 15 working days.

Recommended reading

•    National Pharmacy Association News -August 2005 (www.npa.co.uk )
•    Royal Pharmaceutical Society of Great Britain Council Meeting 2 & August 2005 public business. Item 05.08/C/25 (www.rpsgb.org )
•    Pharmaceutical Pricing and Reimbursement Policies David Kullman - UK Department of Health www.pharmacos.eudra.org/g10/docs/tse/UK.pdf
•    Retail Chemists and Drug Stores report 1999 (www.marketresearch.com/product)
•    Promotion of Medicines in the UK, MHRA (ISBN 0 11 7024384)
•    www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.htm - Bar code label requirement for Human Drugs and Biological Products.
•    Best practice Guideline on the labelling and packaging of Medicines (MHRA guidance note No 25) June 2003. www.mhra.gov.uk.
•    Pharmaceutical Packaging Materials, An Explanatory guide to the GMP requirements of PS9000:2001 www.pqg.org.
•    Primary packaging materials for medicinal products - particular requirements for the application of ISO 9001:2000 with reference to Good Manufacturing Practice/GMP ISO/DIS 15378 www.iso.org.
•    Combating Counterfeit Drugs, February 2004, US F&DA. www.fda.gov./ oc/initiatives/counterfeit.

Study hours

Independent study hours
Independent study 150

Teaching staff

Staff member Role
Justin Wiedemann Unit coordinator

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