Abstract

ROLE OF GMP IN PHARMACEUTICAL INDUSTRIES

Ranjeet Kumar Bhargav*, Rehana Parveen, Shyamuriksh Prajapati and Rohit Kumar Yadav

Abstract

GMP is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standard appropriate to their intended use and as required by the marketing authorization. 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. 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. Good quality must be built in during the manufacturing process; it cannot be tested into the product afterwards. GMP prevents errors that cannot be eliminated through quality control of the finished product.

Keywords: Good Manufacturing Practice, Quality, validation, Pharmaceuticals.