MODULE 2

Regulatory and documentation requirements

Aims

The aims of this module are:

• to examine the concepts of pharmaceutical law and in particular the guidance relating to validation and maintenance of pharmaceutical plant.
• to explain the Documentation Processes that are required to support the validation of pharmaceutical plant and subsequently to maintain it in a compliant state.

Learning outcomes

On completion of this module the student should be able to:

• describe the basic regulatory processes for control of pharmaceutical products.
• describe the principal legislation that regulates the pharmaceutical industry in the UK, EU and USA.
• describe the general principals of GMP in both the EU and USA.
• describe the official guidance.
• describe the unofficial guidance regarding pharmaceutical validation published by organisations such as ISPE, GAMP, the UK IQA PQG, the US PDA, etc.
• describe the concept of lifecycle information management as applied to the conceptual, design construction, validation and operation of a pharmaceutical plant or facility.
• discuss the sources and development of documentary records during the lifecycle of the facility.
• critically assess the importance of documents and records generated during the lifecycle of the facility/plant, with particular emphasis on the needs of change control.
• describe the key technologies that are taking over form paper documents and records.
• evaluate the impact of current and projected regulations as applied to paper and electronic records and document.
• evaluate the compliance of paper and electronic systems used in the operational and maintenance phases of a pharmaceutical facility or plant.
• make a diagram of the principle information flows associated with lifecycle documents and records.

Tutor Information

ANDREW CURRAN

See Module 1.