There is no ambiguity about the role of Good Manufacturing Practice (GMP) in Quality Control. They are conjoined to each other at the core.
First, a basic understanding of GMP in pharmaceuticals
Good Manufacturing Practices (GMP) is a set of principles that is applicable in its own set of ways to certain fields. GMPs constitute a set of guidances that sketches and shapes the aspects of production and testing, which can have a major effect on the quality of a product.
In the area of pharmaceuticals; GMP is a part of a Quality System that covers various activities that are part of pharmaceuticals. These include medical devices, pharmaceutical products, foods, diagnostics, and the manufacturing and testing of pharmaceutical dosage forms or drugs and active pharmaceutical ingredients (APIs).
A word about Quality Assurance
Quality assurance is part of a Quality System, which is the sum of all individual and collective factors that go into assuring the quality of a product. It is made up of all the requirements and arrangements that combine to make the medicinal product meet its quality criteria needed for its intended use.
Now, the conjunction of GMP in a Quality System
GMP is an integral part of Quality Systems. The inseparability of one from the other can be understood from the fact that their objectives are in complete unison. A Quality System for the manufacture of pharmaceutical products needs to ensure the presence of GMP, along with associated aspects such as good laboratory practice (GLP) and good clinical practice (GCP).
In addition, the following points relate the centrality of the role of GMP in Quality Control:
- Operations relating to production, which are quintessential for Quality Control, have to be speciﬁed clearly in a written format. GMP requirements are adopted based on these
- GMP consists of making sure that pharmaceutical products have the right materials and in the perfectly stated dose. This is stated as part of Quality Control
- GMP and Quality Control are linked inextricably in relation to controls, as well. Aspects of in-process controls such as validations and calibrations are carried out in accordance with the terms set out in the two disciplines
- While the product is manufactured in accordance with set principles of GMP; subsequent stages such as processing and checking of the ﬁnished pharmaceutical product have to ensure Quality Control
- Some activities like storage and distribution, as well as evaluations incorporate the principles of both GMP and Quality Control to ensure safety and effectiveness of pharmaceutical products.