European College of Validation

Module 2. Regulatory and documentation requirements

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.

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.