Module 1

Introduction to validation in the pharmaceutical and biotechnology industries

Aims

The aim of this module is to provide the candidate with a basic understanding of the purpose and scope of validation exercises in the pharmaceutical and biopharmaceutical industries. This will be supplemented by a glossary of term and definitions.

Learning outcomes

On completion of the module the candidate will be able to:

• understand the terms and definitions used in validation.
• understand the purpose and objectives of validation.
• Know where and how to find relevant regulatory and other validation guidelines.
• understand the importance of validation of facilities, utilities, equipment, processes, and test procedures in the production of pharmaceutical and biopharmaceutical products.

Tutor Information

ANDREW CURRAN BSc[Pharm] ; FIQA

Andrew joined Abbott Laboratories Ltd in the early 1960’s where he started his career as a Research & Development pharmacist and went on to manage the Sterile Products Department which manufactured a range of injectables and disposable medical devices. 

He continued his career in the pharmaceutical industry, widening his knowledge of pharmaceutical dosage forms whilst working at Crookes Laboratories Ltd [liquids, creams, ointments, ACTH production], Travenol Laboratories Ltd [disposable medical devices, plastics extrusion and injection moulding], and Ortho Pharmaceuticals Ltd [tablets, capsules, packaging], before joining the Medicines Control Agency as an Area Medicines Inspector in 1971.

As an Area Medicines Inspector, and latterly as Regional Principal Medicines Inspector for the Southern Region, Andrew carried out regulatory audits on hundreds of pharmaceutical facilities in the UK, Japan, and throughout Europe.

Having developed a keen interest in validation whilst working in the Inspectorate, Andrew left the Medicines Control Agency in 1993 to become the manager of Regulatory Compliance and Validation with a specialised engineering design company.

Andrew is a Fellow of the Institute of Quality Assurance, and is eligible to be a Qualified Person under the EC Directives.