Good manufacturing practice (GMP) is a system for ensuring that products
are consistently produced and controlled according to quality
standards. It is designed to minimize the risks involved in any
pharmaceutical production that cannot be eliminated through testing the
final product. The main risks are: unexpected contamination of products,
causing damage to health or even death; incorrect labels on containers,
which could mean that patients receive the wrong medicine; insufficient
or too much active ingredient, resulting in ineffective treatment or
adverse effects. GMP covers all aspects of production; from the starting
materials, premises and equipment to the training and personal hygiene
of staff. Detailed, written procedures are essential for each process
that could affect the quality of the finished product. There must be
systems to provide documented proof that correct procedures are
consistently followed at each step in the manufacturing process – every
time a product is made. WHO has established detailed guidelines for good
manufacturing
practice. Many countries have formulated their own
requirements for GMP based on WHO GMP. Others have harmonized their
requirements, for example in the Association of South-East Asian Nations
(ASEAN), in the European Union and through the Pharmaceutical
Inspection Convention.