Quality Assurance and Medicine Safety

Module code: PHA7051-B

Module Aims

To provide the students with the opportunity to develop their knowledge & understanding of the principles of Quality Assurance (QA), Quality Control (QC) & Good Manufacturing Practice (GMP) necessary for assuring & managing product quality in the manufacture of medicines.To provide the students with the opportunity to develop their knowledge & understanding of current regulatory procedures in the licensing of medicines, WHO guidelines for emergency medicine donation &medicines donated to resource-limited countries, the concepts of modern instrumental analysis & the monitoring of the cont O/S

Outline Syllabus

(a) Introduction to QA systems; principles of global QA and QC, Good Pharmaceutical Manufacturing Practice; the ICH guidelines and key managerial issues for the pharmaceutical industry. (b)Sterilisation processes for pharmaceuticals.  (c) The role of International pharmacopoeia standards and monographs in medicine control and protecting public health; ICH guidelines for using analytical method validation in QC.  (d) Systems for regulatory control of drugs: the Licensing authorities, ICH requirements, centralised and decentralised procedures.  (e) Requirements for Pharmaceutical Products Licence approval: development of a drug registration dossier.  (f)  Regulatory issues associated with off-license, paediatric and orphan drugs, counterfeiting, natural products and homeopathic medicines and links with 'NICE'. (g) Quality assurance of donated medicines:  shelf-life,  presentation, packaging and labelling (h) Advanced topics in pharmaceutical analysis, focusing on modern analytical techniques.

Cont from Aims quality of medicines during processing & at the final product stage.

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