Introduction

The United Kingdom pharmaceutical industry has set high standards of research, development, manufacturing and testing of its products in order to promote the healthcare of patients.  The key factor in the success of the pharmaceutical industry is the quality of the people it employs and the training it provides to ensure the maintenance of the established high standards.  A Qualified Person, who is responsible for certifying the suitability for release of medicinal products as part of this industry, requires specialised training and experience in order to fulfil the requirements.

The Medicines and Healthcare products Regulatory Agency (MHRA) of the Department of Health and the Veterinary Medicines Directorate (VMD) of the Department of the Environment, Food and Rural Affairs (DEFRA), require the Institute of Biology, the Royal Pharmaceutical Society of Great Britain and the Royal Society of Chemistry to assess the eligibility of their members for Qualified Person status.

Please refer to the following documents when making an application for certification as a Qualified Person: 

• Guidance Notes 
• Study Guide 
• Code of Practice
• Application Form
• Sponsor Form  

The documents collectively aim to provide detailed information on the requirements for certification and the application process.  Applicants should contact the officer at their respective professional body if further information is required.

New application documents 2006

Applicants should use the 2006 documents which relate to the launch of Study Guide 2006. As applicants sometimes complete their application forms over a period of time, the JPB will accept applications on the old documents until the end of 2006. From 1 January 2007 the 2006 documents must be used.