This module aims to provide the student with:The necessary information to comply with the requirements of European Guidelines with respect to GMP and a knowledge of the requirements of with respect to GMP in the US.
Overview of GMP & GMP Principles
Definition of GMP Regulatory Bodies – FDA, European Commission, IMB, EPA, HAS, FSA. History, Authority and Current Role. GMP Directives – From FDA and E.C. guidelines.
Elements of GMP
Quality Assurance: Principles: 1. Establish quality characteristics, 2. Develop systems to monitor quality characteristics, 3. Control Change, 4. Document history of change. Validation and change control: Examine the meaning of validation. The importance of specifications and limits in validation. Importance of change control to a validated system.Quality Control: QC Procedures, Product/Material Specifications. Testing for conformance to specifications. Use of retained material, stability. Alert and action limits. Compliance Audits: Analysis of the steps involved in audits of the manufacturing environments. Auditing of raw materials, production, processing, packaging, storage and distribution. Corrective actions, reporting audit findings. Major audit issues.Complaints Procedure: Management of complaints and using complaints as a means to improve process.Training: The importance of training in controlled manufacturing environments. Maintenance of training records.
Documentation
Documents and the application of GMP: Types of documents, i.e. Standard Operating Procedures (SOP’s), General Operating Procedures (GOP’s), non-conformance reports,CAPA (Corrective and Preventative Action), batch records, certificates of analysis, control forms and manufacturing protocols etc. Writing and controlling official procedures.
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 40 |
| Formal Examination | 60 |