Good Manufacturing Practice System (GMP) is a system that ensures that products are manufactured and controlled consistently according to quality standards. Covering many sectors, this application is designed to minimize product risks.
In fact, all rules in this system are based on a few basic principles. For example, the production and distribution activities of products have to minimize risks in terms of their quality. A clean and hygienic production area should be provided for production facilities, laboratories and storage areas. Production plant design, operating principles and environmental conditions must be checked to prevent cross-contamination of products.
Production processes must be clearly defined, verified and controlled to ensure compliance with specifications. Any changes to the activities should be evaluated in terms of product safety and product quality, and any changes that may affect product quality must be passed through the necessary approval steps.
Processes and procedures should be written in clear language. During production and quality control, all necessary steps in the defined processes and procedures should be carried out as defined and records should be maintained that the products meet the specified quality specifications. In addition, deviations, if any, should be investigated and recorded.
Production records should be kept in a clear and accessible format, including distribution. A system defining these processes should be established, especially if any party that has been placed on the market has to be recalled from sale or supply.
When complaints are received about products offered to customers, they should be examined, the causes of defects investigated, and the necessary measures should be taken in relation to defective products.
The GMP Good Manufacturing Practice System ensures that quality measures, both production and quality control, are clearly defined, approved, reviewed and documented for production and testing, and that personnel, facilities and materials are suitable for production activities.
This system is a set of rules that must be followed in order to be safe and controlled in all stages from the procurement of raw materials to the production, packaging, labeling and delivery of products such as pharmaceuticals, cosmetics, food, medical devices or products. In short, GMP Good Manufacturing Practices are a quality approach in production.
The enterprises that set up and implement this system follow all production stages since these criteria also meet the quality management system standards. Therefore, products reach consumers in the most healthy way. All processes and employees are kept under control in order to avoid any confusion during production and to prevent errors. This is an important point for enterprises to be reliable and to outperform their competitors. Because the products are produced with the right methods and in the right conditions.
With this system, the enterprises apply to the legal regulations in force and fulfill their legal obligations in a timely manner. Therefore, businesses have gained a significant advantage in international trade.
Low quality products threaten people's health and safety. For example, if companies in the pharmaceutical sector cannot produce drugs of appropriate quality due to a number of problems, this may create a risk of drug shortages in the market and patients may not be able to take their prescription drugs when they need it. The pharmaceutical sector is responsible for ensuring safe and adequate supply. In this respect, the GMP Good Manufacturing Practices System disciplines production activities and enables the necessary precautions to be taken in a timely manner by recognizing possible risks in a timely manner.
The first draft text of the World Health Organization on GMP Good Manufacturing Practices was adopted in 1968. In 1969, the first version on the quality of pharmaceutical products moving in the global market was proposed. However, GMP Good Manufacturing Practices have been designed in the actual 1990s as used today by the American Food and Drug Administration. This standard is a health quality standard that determines the criteria to be followed in all processes from the production stage to the delivery of all kinds of products and services to consumers. Today, more than one hundred countries have incorporated GMP Good Manufacturing Practices into their national legislation and many countries have defined their own national Good Manufacturing Practices requirements.
GMP Good Manufacturing Practices offer a highly effective method to protect consumers' health and at the same time produce quality food, medicine, medical devices or active pharmaceutical products. Although all specification tests have been passed, foodstuffs, medicines or medical supplies that are found to be produced in a facility that contradicts or does not meet the existing GMP Good Manufacturing Practices criteria are not considered to be of good quality.
As mentioned above, the GMP Good Manufacturing Practices criteria cannot be considered as instructions on how to produce products. It describes a set of general principles that must be observed only during production activities. When determining quality programs and production processes, enterprises must meet the requirements of Good Manufacturing Practices.
As a result, the GMP Good Manufacturing Practices System Certificate proves the capabilities of enterprises in terms of product quality and reliability. With this system approach, employees develop their skills in terms of good production criteria and decrease the security risks for product quality and safety in the enterprise. Problems related to production activities and management are identified in a timely manner, thus reducing operating costs. Businesses better understand, follow and regulate the relevant laws and regulations. The reliability and respectability of the business is increasing internationally.
GMP Good Manufacturing Practices are designed with the aim of ensuring that enterprises make goods and production in a continuous and controlled manner. Businesses must produce their products in accordance with quality standards. This system contains basic rules for factory and plant operations. In other words, it is part of a system aimed at maintaining high standards. Thanks to this system, the risks that cannot be eliminated by testing the final products are minimized.
In summary, the GMP Good Manufacturing Practices System is a set of recommended guidelines for companies producing, distributing and selling pharmaceuticals, food companies, cosmetic companies and manufacturers of medical devices. It is a system designed to ensure that production is carried out and controlled in accordance with predetermined quality standards. It covers all aspects of production from raw material procurement to production facilities and the activities of employees.
First, it is determined whether the organization meets the mandatory requirements of the standard and whether to proceed to the next stage.
It is checked whether necessary procedures and audits have been developed and your institution's readiness for evaluation is reviewed.
The findings that arise in the first two stages are evaluated and after all corrective actions are reviewed, document preparation is started.
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