GXP01An Introduction to Good Manufacturing Practice (GMP) for Drug Products

Why GMP? – This session describes the origins of GMP and the consequences of non-compliance.

Regulatory framework – This session describes the legislative instruments and guidance documents which define codes for GMP compliance in the EU, USA and other countries.

Quality management – This session describes the main elements of a quality assurance system which a company would need to establish in order to achieve GMP compliance and describes how procedures for release of product duffer between the EU and USA.

Personnel – This session describes the responsibilities of personnel working in a GMP regulated environment, particularly in relation to training, clothing, protective equipment and hygiene.

Premises – This session describes how building design, layout, organisation and environmental control is an important consideration in a GMP environment.

Equipment  – This session emphasises the importance of using clean, calibrated, well maintained and validated equipment in a GMP environment.

Documentation principles – This session sets out the requirements for record keeping, with particular reference to creation, amendment, authorisation, retention and retrieval.

Document types – This session specifies the contents of a range of document types. It also provides examples of good and bad practice in the layout of records.

Production principles – This session outlines the general principles that apply to all production processes, especially validation, change-control and measures to prevent contamination and cross-contamination.

Materials and operations – This session describes checks and controls which should be applied to starting and packaging materials, process and packaging operations and handling rejected or returned materials and products.

Quality Control – This session identifies the responsibilities of the Quality Control department with particular reference to documentation, sampling and stability testing.

Contract manufacture and analysis – Pharmaceutical manufacturers may contract out analysis or production work. This session describes the responsibilities of the contract giver and acceptor and outlines the contents of a contract.

Complaints and product recall – This session describes how a manufacturer should handle product complaints and manage product recall operations.

Self-inspection – In this session the main characteristics of a self inspection programme are described and issues concerning the disclosure of self-inspection reports to regulatory inspectors are discussed.

Assessment – Multiple-choice mastery assessment.