Principles of Good Manufacturing Practice

PRINCIPLES OF GOOD MANUFACTURING PRACTICE

INTRODUCTION

Regulatory authorities require that pharmaceutical products be manufactured according to the principles of good manufacturing practice (GMP) (also referred to as current good manufacturing practice, cGMP). Such authorities include the European Union (EU), the UK Medicines and Health Care Products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA). Products manufactured in the UK for the US market must satisfy the FDA. GMP guidelines were first given statutory authority in the USA and published in the UK in 1971 (see Immel, 2000 and Sharp, 2009 for a more detailed history).

Compliance must not, however, be seen as a regulatory burden. Failure in GMP can have massive consequences for the well-being of the patient and the finances of the manufacturer. For the manufacturer it can lead to litigation, losses associated with recall of product or loss of licence with attendant bad publicity. Furthermore, an incident in 2004 of failure in GMP for vaccine manufacture at a UK company led to a major shortage of fluvaccine in the USA.

Some products, such as injections, must be sterile, while others, such as oral drugs, need not be sterile but must be free from pathogens that can be contracted via the oral route (British Pharmacopoeia Commission, 2010, Appendix XVI D). More space in the literature is dedicated to quality of sterile products than that of non-sterile products, but this reflects the additional quality assurance requirements compared to those for non-sterile products (Sharp, 2000; Butson & Hawitt, 2008).

The manufacture of sterile products is carried out in both industry and hospitals. In the latter, batches tend to be much smaller, sometimes only one item, and the products are stored for a much shorter time, usually less than 24 hours (Beaney, 2005).