As the cases of spurious drugs are increasing day by day, the role of Good Manufacturing Practices has become significant. GMP is also termed as   cGMP i.e. current Good Manufacturing Practices. It is a term that is recognised worldwide for the control, management of manufacturing and quality control testing of foods and pharmaceutical products. GMP takes the holistic approach of regulating the manufacturing and laboratory testing environment itself. An extremely important part of GMP is documentation of every aspect of the process, activities and operations involved with the drugs and medical device manufacturing. If the documentation showing how the product was made and tested is not correct and in order, then the product does not meet the required specification and is considered contaminated  or adulterated. GMP requires that all manufacturing and testing equipment has been qualified as suitable for use, and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilised in the drug manufacturing process have been validated (according to predetermined specifications), to demonstrate that they can perform their functions.

GMPs comprise a variety of practices that ensure quality including things such as:

• Raw materials quality assurance
• Record-keeping of substances throughout the manufacturing process
• Standards for cleanliness and safety
• Qualifications of manufacturing personnel
• In-house testing
• Production and process controls
• Warehousing and distribution

 GMP is designed to help assure the quality of drug products by ensuring several key attributes, including correctness and legibility of recorded manufacturing and control documentation.