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 / Regional Principal Medicines Inspector, Andrew carried out regulatory audits on hundreds of pharmaceutical facilities in the UK, Japan, Korea, 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 before joining the Health Protection Agency, Porton Down where he was Compliance Manager until he retired in 2004.

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