MODULE SPECIFICATION TEMPLATE
MODULE DETAILS
Module title
Module code
Credit value
Level
Mark the box to the right of the
appropriate level with an ‘X’
Industrial Manufacturing Processes
CHM09
10
Level 4
Level 5
Level 6
Level 0 (for modules at foundation level)
Level 7
X
Level 8
Entry criteria for registration on this module
Pre-requisites
Successful completion of Year 3 of the MPharm degree
Specify in terms of module codes or
equivalent
Co-requisite modules
None
Specify in terms of module codes or
equivalent
Module delivery
Mode of delivery
Taught
Other
X
Distance
Pattern of delivery
Weekly
X
Block
Placement X
Online
Other
When module is delivered
Semester 1
Semester 2
X
Throughout year
Other
Brief description of module This module enables students to demonstrate a sound understanding of
the production, testing, distribution and regulatory aspects of medicine
content and/ or aims
production in the pharmaceutical industry, and to meet the demand for
Overview (max 80 words)
capable pharmacy graduates who can contribute to the continued growth
and development of the pharmaceutical industry.
Module team/ author/
Dr Ananth Pannala, other members of PABS staff and VLs from
coordinator(s)
Pharmaceutical Industry
School
PABS
Site/ campus where
delivered
Moulsecoomb
Course(s) for which module is appropriate and status on that course
Course
Status (mandatory/ compulsory/
optional)
Optional
MPharm
MODULE AIMS, ASSESSMENT AND SUPPORT
Aims
To enable students to develop a critical understanding of the processes
involved in the manufacture of medicinal products by the
pharmaceutical industry.
Learning outcomes
At the end of the module the students should be able to demonstrate:
LO1
A systematic understanding of knowledge and critical
awareness and insights of the nature and obligations imposed
by working in an industrial setting.
LO2
A critical understanding of the key processes involved in the
LO3
Content
procurement, storage and usage of the raw materials in
pharmaceutical manufacturing of medicinal products
Insight into complexity of the key processes in packaging
medicinal products to enable them to comply with the
Pharmaceutical Industry Quality requirements.
The module will comprise of 8 hours of lectures and 18 hours of
placement in an industrial setting. Indicative content will include:

Learning support
Basic guidelines of working in an industrial setting; nature and
obligations imposed by working in an industrial setting; application
of COSHH and standard operating protocols (SOPs)
 Processes involved in the procurement of raw materials from
suppliers – both active pharmaceutical ingredients as well as
excipients
 Production methodologies and the equipment used including
installation qualification, performance qualification, operational
qualification and validation.
 Regulatory processes for the manufacture of medicinal products
(GMP). Formulation techniques, production methodologies or other
scientific techniques associated with the chosen formulation type
 Quality management and quality systems management in the
pharmaceutical industry
 Pharmaceutical packaging: materials, procedures, regulatory
requirements, distribution and SOPs
During their placements, the student will be referred to text books,
SOPs and industrial regulations as appropriate to the specific work
setting, in addition to relevant lecture material
Text books (current editions):
 MHRA Rules and Guidance for Pharmaceutical Manufacturers and
Distributors
 The Theory and Practice of Industrial Pharmacy, L Lachman, HA
Lieberman and J Kanig, Lea and Febiger.
 Mossialos et al. (Eds): Regulating Pharmaceuticals in Europe:
Striving for Efficiency, Equality and Quality. Open University Press.
 Rang: Drug Development and Development, Technology in
Transition. Churchill-Livingstone.
 Sarker: Quality Systems and Controls for Pharmaceuticals. Wiley.
 Tobin & Walsh: Medical Product Regulatory Affairs:
Pharmaceuticals, Diagnostics and Medical Devices, WileyBlackwell.
Other information:
Essential websites: EMEA (www.ema.europa.eu),
FDA (www.fda.gov) and MHRA (www.mhra.gov.uk).
Teaching and learning activities
Details of teaching and
learning activities
Through a mixture of lectures, industrial visits, private study and
assignments. 100 hours, approximately 8 hours of lectures, 18 hours of
industrial placements (6 x 3 h placements), 74 hours private study
including course work.
Allocation of study hours (indicative)
Study hours
Where 10 credits = 100 learning hours
SCHEDULED
This is an indication of the number of hours students can expect to
spend in scheduled teaching activities including lectures, seminars,
tutorials, project supervision, demonstrations, practical classes and
workshops, supervised time in workshops/ studios, fieldwork,
external visits, and work-based learning.
8
GUIDED INDEPENDENT
STUDY
All students are expected to undertake guided independent study
which includes wider reading/ practice, follow-up work, the
completion of assessment tasks, and revisions.
74
The placement is a specific type of learning away from the University
that is not work-based learning or a year abroad.
PLACEMENT
TOTAL STUDY HOURS
18
100
Assessment tasks
Details of assessment for
this module
Types of assessment task1
3000 word written assignment. The topic of the assignment to be
agreed between module leader and industrial contact. This could be,
but is not limited to, a critical review of a particular process, or an
analysis of a problem encountered in the production process.
% weighting
Indicative list of summative assessment tasks which lead to the award of credit or which are required for
progression.
WRITTEN
Written exam
COURSEWORK
Written assignment/ essay, report, dissertation, portfolio, project
output, set exercise
PRACTICAL
Oral assessment and presentation, practical skills assessment, set
exercise
(or indicate if
component is
pass/fail)
100
EXAMINATION INFORMATION
Area examination board
Chemistry and Pharmaceutical Sciences
External examiners
Name
Position and institution
Date appointed
Date tenure
ends
Dr S Murdan
Senior Lecturer, UCL School of Pharmacy
01/10/08
30/09/13
QUALITY ASSURANCE
Date of first approval
N/A
Only complete where this is not the
first version
Date of last revision
N/A
Only complete where this is not the
first version
Date of approval for this
version
April 2013
Version number
1
Modules replaced
N/A
Specify codes of modules for which
this is a replacement
Available as free-standing module?
Yes
No
1 Set exercises, which assess the application of knowledge or analytical, problem-solving or evaluative skills, are included
under the type of assessment most appropriate to the particular task.
X