The pharmaceutical industry is based on Good Manufacturing Practice (GMP); GMP is not only applied in the pharmaceutical industry, but also in food, cosmetics, etc., but not to the same extent as in the pharmaceutical industry. GMP regulations are the way it should be applied in the pharmaceutical industry, but they have become a legal standard with added legal enforcement. Regulations differ slightly from country to country, but the ultimate goal is the same: to guarantee the efficacy and safety of the products produced, and to have a consistent production control policy to ensure product quality on a permanent basis. This will ensure that the medicines supplied are safe for consumers and give them a quality they can trust.

GMP is necessary to achieve this objective. In the United States, GMP is defined as ensuring safety (S), Identity (I), Strength (S), purity (P), and quality (Q) in processing, manufacturing, packaging, and storage processes. In Japan, the three principles of GMP also state (1) prevention of cross-contamination, (2) prevention of human error, and (3) advanced quality assurance system.

Good Manufacturing Practice (GMP) originated in the United States in the 1960s and is now a globally recognized term for the management and control of all aspects of food and pharmaceutical manufacturing, testing, and quality control. Good Manufacturing Practice (GMP) is a system for ensuring that products are manufactured according to a quality system established to maintain product quality on a consistent basis and to ensure that the expected quality is achieved. For example, in order to prevent cross-contamination, it is essential to determine a procedure to completely wash the previous product to prevent contamination from outside as well as contamination from other products, and to verify the effectiveness of this procedure (cleaning validation). It is also necessary to plan the flow of people and goods so that workers do not bring in other products.　Thus, a quality assurance system must refer not only to the operation of manufacturing operations, but also to the design of equipment and facilities.

Prevention of human error refers to the misreading of similar labels, which can result in a recall if a product is mislabeled. Quality assurance measures, such as changing labels to make them less prone to errors, avoiding the production of products with similar labels on nearby lines, and educating workers, require both software measures, such as operations and regulations, and hardware measures, such as layout and partitions between packaging lines. In addition, clear procedures (Standard Operating Procedures: SOPs) must be established to prevent mistakes, and education and training must be provided to ensure that all employees are familiar with these procedures. All implementation and verification work must be recorded, stored, and guaranteed. This documentation system is also a must.

PT CCI, as a member of the CM Plus group, is an organization that is dedicated to supporting GMP implementation and provides optimal solutions in terms of both software and hardware required for GMP for clients seeking compliance with international GMP standards such as EU-GMP, PIC/S, cGMP, J-GMP, WHO-GMP, and FDA cGMP. We offer professional services that provide optimal solutions in terms of both software and hardware required for GMP. We also provide professional services to implement the latest and best GMP practices, including the provision of paperless validation systems to maintain and improve quality in the pharmaceutical industry, which is becoming increasingly high-tech.