A synopsis of the curriculum
• Basic Introduction to GxP
• Good Laboratory Practices (GLP)
• Good Manufacturing Practices (GMP)
• Reasons for validation
• Non-Conformance investigations and Reporting
• Good Aseptic Practices (GAP)
• Good Clinical Practices (GCP)
• Risk Based Compliance
• Quality Audits
Blended distance learning:
Contact hours: 120 hours
Private Study Time: 30 hours
Total Learning Time: 150 hours
Portfolio, two coursework assignments and exam
Weighting:
2 Essay Assignments 40% (20% each)
Portfolio 20% - composed of 5 individual assignments where topics are applied to the workplace
Exam (40 minutes) 40% - MCQs
The pass mark for each individual assessment is 40%. All assessments must be passed in order to pass the module.
MHRA (2007) Rules and Guidance for Pharmaceutical Manufacturers and Distributors. Pharmaceutical Press.
Anna Lunden (2008) The GMP Handbook. Lunden-Ellow.
See the library reading list for this module (Medway)
The intended subject specific learning outcomes.
On successfully completing the module students will be able to:
Demonstrate a critical understanding of well-established pharmaceutical/industry GxP requirements.
Apply the relevant GxP legislation that is applicable to their own work environment, to well defined contexts.
Apply the relevant tools and established techniques used in GxP risk-based compliance to a work-related activity, producing a summary report and recommendations.
Demonstrate knowledge and critical understanding of audits in quality management and carry out an internal compliance audit in accordance with the legislative requirements.
Complete a non-conformance investigation and deviation report to a reasonable level, using the appropriate investigation techniques.
The intended generic learning outcomes.
On successfully completing the module students will be able to:
Analyse, evaluate and correctly interpret data.
Present and communicate data effectively.
Obtain and use information from a variety of sources as part of self-directed learning.
Display time-management and organisational skills within the context of self-directed learning.
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