Course Scope:
Revisions to EU GMPs mean that the responsibilities of the Qualified Person regarding Active Pharmaceuticals are wider than ever.
These include formally certifying that each Active Pharmaceutical Ingredient (API) is manufactured to GMP, knowledge of the API supply chain and complying with importation requirements as defined in the Falsified Medicines Directive. This course includes both the technical aspects of manufacturing APIs and the requirements of Good Manufacturing Practice.
Overview:
At the end of the course you will know:
鈥he role of the QP relevant to APIs
鈥he regulatory framework for the manufacture of APIs
鈥he requirements of the Falsified Medicines Directive and APIs
鈥ow to use the European Guide to GMP for APIs
鈥he contents of a Drug Master File
鈥ethods and equipment used in synthesis
鈥equirements for specifications, organic solvents and impurities
鈥rocess and cleaning validation
鈥he control of packaging materials for an API
Who should attend:
An essential course for all those who expect to be taking the QP Viva, it is also a valuable contribution to Continuing Professional Development for QPs who qualified some years ago. This is suitable for those who require an understanding of the requirements for manufacturing APIs such as purchasing, manufacturing or regulatory affairs staff.
Revisions to EU GMPs mean that the responsibilities of the Qualified Person regarding Active Pharmaceuticals are wider than ever.
These include formally certifying that each Active Pharmaceutical Ingredient (API) is manufactured to GMP, knowledge of the API supply chain and complying with importation requirements as defined in the Falsified Medicines Directive. This course includes both the technical aspects of manufacturing APIs and the requirements of Good Manufacturing Practice.
Overview:
At the end of the course you will know:
鈥he role of the QP relevant to APIs
鈥he regulatory framework for the manufacture of APIs
鈥he requirements of the Falsified Medicines Directive and APIs
鈥ow to use the European Guide to GMP for APIs
鈥he contents of a Drug Master File
鈥ethods and equipment used in synthesis
鈥equirements for specifications, organic solvents and impurities
鈥rocess and cleaning validation
鈥he control of packaging materials for an API
Who should attend:
An essential course for all those who expect to be taking the QP Viva, it is also a valuable contribution to Continuing Professional Development for QPs who qualified some years ago. This is suitable for those who require an understanding of the requirements for manufacturing APIs such as purchasing, manufacturing or regulatory affairs staff.
