Good Manufacturing Practices (GMP)

Good Manufacturing Practices (GMP) are practices required to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. [These guidelines provide the minimum requirements that a manufacturer must meet to ensure that its products are consistently of high quality, from batch to batch, for their intended use. The rules governing each industry may vary greatly; however, the primary purpose of GMP is always to prevent harm to the end user. Additional principles include ensuring that the final product is free from contamination, that it is consistent in its manufacture, that its manufacture is well documented, that employees are well trained, and that the product has been quality-checked beyond just the final stage. Good manufacturing practices are typically ensured through the effective use of a quality management system (QMS).

A Good Manufacturing Practice (GMP) system ensures that products are consistently manufactured and controlled to quality standards. Covering many sectors, this application is designed to minimize product risk.

Good Manufacturing Practices for Food or GMP

It is the system that aims to ensure the safety of the stages and steps of production processes, and their safety for products that are directly related to human health, whether food – medicines – or cosmetics, and is considered one of the best certificates that a food or pharmaceutical facility may obtain, and the GMP certificate covers the basic processes in the manufacturing or production process (production site – surrounding environment – tools used – production process – raw materials – workers in the institution … etc.)

GMP also covers cosmetics and food establishments, and its primary goal is to reduce the risk of product contamination during manufacturing, whether from internal or external sources

The main principles of the Good Manufacturing Practices System GMP

All rules in this system are based on some basic principles. For example:

• Production and distribution activities must reduce risks in terms of their quality. A clean and healthy production area must be provided for production facilities, laboratories, and storage areas. The design of the production plant, operating principles, and environmental conditions must be verified 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 must be evaluated in terms of product safety and product quality, and any changes that may affect the quality of the product must go through the necessary approval steps.
• Processes and procedures must be written in clear language. During production and quality control, all necessary steps in the specified processes and procedures must be carried out as specified and records must be maintained that the products meet the specified quality specifications. In addition, deviations, if any, should be investigated and recorded.
• Production records must be kept in a clear and accessible form, including distribution. A system must be established that defines these processes, especially if any product that has been put on the market must be recalled from sale or supply.
• When complaints are received about products supplied to customers, they should be examined, the causes of defects investigated, and necessary measures taken concerning defective products.

GMP Good Manufacturing Practices is an aspect of quality assurance that ensures that products are manufactured and controlled consistently and following their intended use, following the required quality standards.

Benefits of Implementing Good Manufacturing Practices

The Good Manufacturing Practices system ensures that quality standards, 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 to be safe and controlled at 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 medical products. In short, the Good Manufacturing Practices of the Good Manufacturing Program is a quality approach to production.

Companies that prepare and implement this system follow all stages of production because these standards also meet the standards of the Quality Management System. Therefore, the products reach consumers in a very healthy way. All processes and personnel are kept under control to avoid any confusion during production and prevent errors. This is an important point for companies to be reliable and outperform their competitors. Because the products are produced in the right ways and under the right conditions.

With this system, enterprises apply the applicable legal regulations and fulfill their legal obligations promptly. Therefore, companies have gained a great advantage in international trade.

Importance of Good Manufacturing Practices

Poor quality products threaten people’s health and safety. For example, if companies operating in the pharmaceutical sector are unable to produce medicines of appropriate quality due to many problems, this may lead to the risk of drug shortages in the market and patients may not be able to take the medicines they need when they need them. The pharmaceutical sector is responsible for ensuring safe and sufficient supplies. In this regard, the Good Manufacturing Practices system controls production activities and enables the necessary precautions to be taken on time by recognizing potential risks.

The first draft of the WHO text on Good Manufacturing Practices was adopted in 1968. In 1969, the first version was proposed on the quality of pharmaceutical products moving into the world market. However, it was in the 1990s that the actual GMP as used today by the US Food and Drug Administration was designed. This standard is a health quality standard that sets the standards to be followed in all processes from the production stage to the delivery of all types of products and services to consumers. Today, more than a hundred countries have incorporated GMP into their national legislation and many countries have defined their own national GMP requirements.

GMP provides a company with a very effective way to protect the health of consumers and at the same time produce high-quality foods, medicines, medical devices, or effective pharmaceutical products. Despite passing all the specification tests, food, medicines, and medical supplies found in a facility that conflicts with or does not meet current GMP standards are not considered to be of good quality.

As mentioned above, GMP standards cannot be considered guidelines on how products should be produced. It describes a set of general principles that should only be observed during production activities. When determining quality programs and production processes, companies must meet the requirements of Good Manufacturing Practices.

The Good Manufacturing Practices System certification demonstrates the capabilities of enterprises in terms of product quality and reliability. Using this system approach, employees develop their skills concerning good production standards and reduce security risks to product quality and safety in the enterprise. Problems related to production and management activities are identified promptly, thus reducing operating costs. Companies better understand, follow, and regulate relevant laws and regulations. The company’s credibility and respect at the international level are increasing.

The Good Manufacturing Practices System is designed to ensure that companies manufacture goods and produce in a continuous and controlled manner. Companies must produce their products following quality standards. This system contains the basic rules for factory and factory operations. In other words, it is part of a system aimed at maintaining high standards. Thanks to this system, risks that cannot be eliminated by testing finished products are reduced.

In short, the Good Practices System is a set of recommended guidelines for companies that produce, distribute, and sell medicines, food companies, cosmetic companies, and medical device manufacturers. It is a system designed to ensure that production is carried out and controlled according to pre-established quality standards. It covers all aspects of production from the procurement of raw materials to production facilities and personnel activities.

GMP Plus – Feed Industry Good Manufacturing Practices System

This system was developed to establish a feed safety system for animals taking into account animal health and environmental issues to minimize risks to human health. It also takes into account relevant aspects of international requirements for ensuring food safety.

It also defines minimum hygiene and sanitation standards as well as quality assurance and feed safety standards within the framework of applicable legal regulations. It is necessary to produce safe, clean, and healthy food of animal origin.

Animal feed plays a leading role in the global food industry, which enables the economical production of animal products worldwide. The feed produced in food, fiber, and similar forms is used to feed animals under a wide range of agricultural conditions.

For the efficient and intensive production of meat, milk, eggs, and other foods, mixed and balanced feeds must be used. Safe feed products need to ensure adequate food security at all stages of growth and production, ensure that farms maintain food safety, reduce production costs, maintain or improve food quality and consistency, and improve animal health and welfare.

Likewise, by providing only the required amount of biologically usable nutrients, the possibility of contamination from animal waste is reduced. The GMP Plus system must be used in conjunction with well-planned and effective waste management systems to ensure environmental safety.

Food safety risks associated with animal feed are of biological, chemical, or physical origin. The extent of the risk depends on its source, mode of transmission, and time of exposure. Therefore, risk management must be based on a comprehensive basis. Risks also arise from source materials as well as contamination of products during transport, storage, and transportation.

The GMP Plus Good Manufacturing Practices system for the feed industry in the Netherlands was designed in 1992 in the feed industry. This standard was then integrated with the quality systems published by the International Organization for Standardization (ISO) and the Hazard Analysis and Critical Control Points (HACCP) standards and developed into a certification system. This system covers many conditions for the storage and transportation of products, the qualifications of employees, and the definition of processes in feed production facilities.

Good Manufacturing Practices for the Feed Industry GMP Plus

The GMP Plus Good Manufacturing Practices for the Feed Industry system provides many benefits to companies operating in this field. For example, companies with the GMP Plus feed safety certificate have proven their production quality at an international level. The GMP Plus standard covers other national and international standards and allows companies to focus on risk assessment and quality production.

Companies with the GMP Plus Feed Production System Certificate for the Feed Industry can offer their products and compete worldwide. This document enhances the reputation of companies.

At the same time, this standard is compatible with other national and international programs and can be easily integrated with other systems.

Finally, one of the advantages of the certificate is that it increases traceability in the feed production chain. In this way, safe, healthy, and high-quality animal feed is ensured and delivered to farms that produce animal products under safe conditions.

Why is GMP Plus a Good Manufacturing Practice for the Feed Industry?

With the application of the GMP Plus Good Manufacturing Practices for the Feed Industry system, the effects of the use of antimicrobials in animals on food safety are reduced. Many newly recognized undesirable substances such as melamine, dioxin, and dioxin-like polychlorinated biphenyls are monitored. The presence of genetically modified organisms, plants, and enzymes in feed is examined. The side effects of new technologies used in feed production, such as biofuel production, are monitored. On the other hand, new technologies such as the use of nanotechnology products in feed are under development, and in the quest to improve aquatic nutrition in the aquaculture sector, undesirable substances and microorganisms in feed must be identified.

The GMP Plus system uses the following criteria to determine the risks threatening feed: the importance of the risk to human health, the degree of occurrence of the risk, and the impact of the risk on international trade in food and feed.

The GMP Plus system for the feed industry requires that feed and feed ingredients are protected from contamination with harmful substances or chemical, physical, or microbiological contaminants or other unacceptable substances during production, use, storage, and transportation.

Feeds must be in good condition and meet generally accepted quality standards. Where appropriate, the principles of Good Agricultural Practices, Good Production Practices and Hazard Analysis, and Critical Control Points should be followed to monitor hazards in foodstuffs. Potential sources of contamination from the environment should be considered.

Feed additives should be obtained from safe sources and their ingredients should be subject to risk analysis. In particular, feed additive manufacturers should provide clear information to the user to ensure correct and safe handling. Monitoring of feed ingredients should be carried out using risk-based protocols. Feed ingredients should comply with accepted standards for pathogens, mycotoxins, pesticides, and undesirable substances that may pose health risks to consumers.

Guidance for Consulting and Training

We have the knowledge and experience to help institutions and individuals, comply with the requirements of the Saudi Standards and Quality Organization, the Saudi Food and Drug Authority, and other entities that impose legal and mandatory requirements in the Saudi market.