This subject provides the students with an understanding of the role of Quality Control(QC) and Quality Assurance(QA) within the Pharmaceutical industry. During this course the student will develop an appreciation for the important link between QC and QA with Material Critical Attributes and Good Manufacturing Practices. This subject also explains the differences between testing for product quality (Q.C.) and the far broader ideas of QA which aim to ensure product quality by preventing quality problems.
1. To explain the key role that quality control plays in the manufacture of medicinal products and to outline the limitations of quality control and the need for quality assurance. 2. To provide an understanding of quality control techniques used throughout the manufacturing cycle. 3.To describe the QA principles used in research and development of a new pharmaceutical product and marketing of same. 4. To outline the QA principles used in design and construction of manufacturing facilities and in validation of equipment and processes. 5. To describe fully the legal requirements of the Good Manufacturing Practice (GMP) regulations which apply to quality control and quality assurance in laboratory work.
Regulations and Standards:
Definitions of Quality Control (Q.C.), Quality Assurance (Q.A.), and Good Manufacturing Practices (G.M.P.)
The role of QA, QC and GMP in Pharmaceutical manufacture and protection of public health.
The legal requirements – GMP regulations.
Quality Control Techniques.
Statistical Sampling Plans ANSI, Mil Standards.
Material specifications and USP, BP, EUP etc.
Inspection and testing.
Recording and trending data. Reporting systems.
Corrective and preventative actions.
Quality status assignment.
Process Validation and Q.C.
GMP in the Laboratory:
GMP regulations for Quality Control Laboratories.
Personnel (organization, training and hygiene).
Premises and Equipment (calibration, maintenance and validation).
Materials handling (lab materials and test samples).
Documentation (specifications, test methods, procedures (SOPs), records and reports).
Raw material testing.
In-process and finished product testing.
Status assignment and out-of-specification results.
Quality Assurance: VOLUME 4 of European regulations associated with Medicinal products for human and veterinary use : Good manufacturing practices
Chapter 1__Quality Management
Chapter 3__Premise and Equipment
Chapter 7__Contract Manufacture and Analysis
Chapter 8__Complaints and Product Recall
Chapter 9__Self Inspection Medicinal Products USA:
The course will be taught through the medium of lectures and self directed learning will play a major role in the overall learning strategy.
|Module Content & Assessment