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GMP

GMP Good Manufacturing Practice Certification

GMP Good Manufacturing Practice Certification

What are GMP Good Manufacturing Practices?

GMP Good Manufacturing Practices is a system designed especially for the manufacturers operating in the pharmaceutical and food sector and is based on basic quality requirements for a healthy production.

The first studies in this direction in the European Union countries have been in cosmetics field in 2010. As a result of these studies, the Cosmetic Regulation was published and it was obligatory to apply the principles of Cosmetic Regulation in all European Union countries including candidate countries.

GMP is an acronym for Good Manufacturing Practices, which means Good Manufacturing Practices in English. Good Manufacturing Practices, although primarily started with cosmetics, nowadays, medicines, medical devices and equipment, food and cosmetics in many areas related to the health of people produced products, healthy conditions and requires the production of reliable environments. This system not only deals with products and employees, but also deals with all aspects of manufacturing companies. In this context, production places, machinery and equipment used, relations with the environment, production processes, the properties of the raw materials used, the qualifications and experiences of the employees are all factors that determine the product reliability and quality.

The Good Manufacturing Practices System also ensures that the products comply with certain standards, starting from the introduction of more raw materials to production facilities, including design work, production, packaging, warehousing and distribution in all other processes.

In terms of concern for human health, it is the primary responsibility to eliminate or at least minimize the possibility of pollution of products from internal and external sources in terms of manufacturers operating in sectors such as pharmaceuticals, food and cosmetics. Necessary measures are taken in this regard with the legal arrangements made in our country. The main issue is that such products are produced under reliable conditions and specified standards.

In fact, the emergence of the understanding of Good Manufacturing Practices goes back to the years of 1990. In those years, the US Food and Drug Administration has developed a health quality standard that explains the conditions that must be adhered to in all processes, including delivery of various products and services to consumers. This standard has been accepted by the World Health Organization and many other international organizations and has become widespread in 2000.

Today, the areas where the GMP Good Manufacturing Practices System is implemented have expanded considerably. For example, ISO 9001 Quality Management System, ISO 14001 Environmental Management System, HACCP Hazard Analysis and Critical Control Points System, ISO 22000 Food Management System, OHSAS 18001 Occupational Health and Safety Management System, SA 8000 Social Responsibility System, ISO 16949 Automotive Sector Quality Management System and ISO 13485 and 13488 Medical Devices Management System. All these systems include practices for the provision and protection of health, environment, quality and hygiene conditions at international level.

ISO 22716 Cosmetic Good Manufacturing Practice System Surgery

The International Organization for Standardization (ISO), in practice, publishes the standard of ISO 2007 Cosmetic Good Manufacturing Practice System in 22716 by combining many domestic and international standards published at various times to ensure the safety and quality of cosmetic products. It is designed to meet the needs of the standard cosmetic industry and covers all cosmetic and personal care products.

This standard is the basis of the GMP Good Manufacturing Practice standard, which was developed later on and aimed to ensure the production of effective and reliable products in various health-related sectors. The Good Manufacturing Practices standard provides guidance in determining the production conditions of medicines, food, medical devices and the like.

ISO 22716 standard, which brings a comprehensive Quality Management System approach in the production, testing, packaging, storage and many processes of cosmetic products, can be easily established in enterprises. Since consumers now claim cosmetic product safety as the first condition, the manufacturers turn to ISO 22716 standard in order to meet the demands in local and foreign markets.

The principles of the Cosmetic Regulation published in the European Union countries are based on the conditions of this standard. The Regulation obliges the application of this standard. For this reason, in order to comply with the legal regulations and to have the ISO 22716 certificate and to take advantage of its advantages, the manufacturers establish and manage the ISO 22716 Cosmetic Good Manufacturing Practices System.

In our country, this standard was published in 22716 by the Turkish Standards Institute with the title of TS EN ISO 2013 Cosmetics, Good Manufacturing Practices (GMP), Good Manufacturing Practices.

This standard is the guideline for the production, control, storage and dispatch processes of cosmetic products. This standard covers topics related to the quality of cosmetic products. However, it does not cover the safety and environmental protection of the personnel employed as a whole. Environmental and safety issues are among the basic responsibilities of the enterprises and these issues are audited within the framework of relevant legal regulations. At the same time, this standard does not apply to ongoing research and development activities and to the conditions of distribution of finished products.

In brief, the main objective of the TS EN ISO 22716 standard is to prevent the possibility of contamination due to internal and external sources in the production processes of cosmetic products and the measures that manufacturers must take in this regard.

It is important that manufacturing companies which export to foreign countries, especially to European Union countries, comply with ISO 22716 standard. The legal regulations that are in force also require that companies producing cosmetic products are registered with the Ministry of Health and that they are notified of all products they produce. It is not possible for businesses that do not comply with these principles to fight against their competitors.

Today, Turkish Standards Institute, both for the cosmetic products to be produced and exported in our country, as well as from foreign countries to be delivered to the domestic market for products to be offered certification studies are made.

What are the requirements of the GMP Good Manufacturing Practice System?

The GMP Good Manufacturing Practice System is concerned with the direction of both production and quality control of health products as described above. Therefore, it is possible to sort the requirements of the system as follows:

  • All processes should be reviewed and clearly determined during the production stages. Essentially, the products are in compliance with the standards.
  • Processes critical to production processes and changes to these processes should be approved.
  • The healthy implementation of the system depends on the provision of certain facilities. For example, employees should be trained and qualified, operating conditions should be suitable for production, proper and appropriate materials should be used in production, suitable machinery and equipment should be provided in the enterprise, application instructions and work flow principles should be prepared, suitable storage areas should be provided for the products produced and methods.
  • Employees must be trained in the Good Manufacturing Practice System and comply with the workflow and practice guidelines that have been prepared.
  • During production activities, records that show that the works are done in accordance with the application instructions and work flow diagrams and that the products are of the desired quality should be kept.
  • If there are deviations in production, they must be recorded.
  • Retained records should be accessible to the relevant people.
  • Distribution activities should be done away from the various risks that may affect the quality of the products.
  • In the unlikely event that the products have to be recalled from the market, an order must be established in the enterprise.
  • A system should be established, evaluated and responded to possible consumer complaints.

When all these requirements are fulfilled, the manufacturers obtain significant advantages. Naturally, the firm's market value and dignity will increase. At the same time, the company will always be prepared for the necessary official inspections to be made, as the relevant legal arrangements will be complied with due to the activities appropriate to the processes.

What are the Principles of GMP Good Manufacturing Practice System?

The principles underlying the GMP Good Manufacturing Practice System are as follows:

  • Quality Management System should be established and implemented in the manufacturer
  • The organizational structure and employee qualifications of the company must be overhauled with an effective management approach
  • The company must comply with the expected standard of production facilities, building, machinery, equipment and materials.
  • Application instructions, work processes and workflow diagrams must be in writing
  • Principles for the introduction, processing, storage and distribution of raw materials to production facilities
  • Quality control and proficiency tests of products must be made
  • The authorization steps of the activities of the Company and the authorities and responsibilities of all persons and all employees must be determined.
  • Consumer complaints receiving, evaluation and response systems should be established
  • Processes for withdrawal of products from the market should be established in unexpected situations
  • Processes for investigating possible production defects should be identified and necessary measures taken
  • Processes for the destruction of problematic products or returned products must be identified
  • Internal and external audits of the company

In short, these principles are intended to ensure the quality and health of the products that affect human health. Good production practices and hygienic conditions in production are achieved only by GMP Good Manufacturing Practices System. Good manufacturing practices ensure the continuous production of products in line with the quality standards of the manufacturers and in line with the market needs. In general, GMP Good Manufacturing Practices are part of the quality assurance system and consider quality as an integral part of the product. A properly implemented quality assurance system is closely linked to Good Manufacturing Practices, quality control and quality risk management factors in terms of product reliability.

What is the Good Manufacturing Practice System for GMP?

What is important is that many products with serious consequences for human health, such as medicines, medical devices and equipment, food and cosmetics, are produced in accordance with hygienic conditions, are of high quality and do not pose a threat to human health. In this respect, the GMP Good Manufacturing Practice System standard provides numerous benefits for both producers and consumers.

The achievements of the manufacturers who have been awarded the Good Manufacturing Practices standard and received the GMP Good Manufacturing Practices certificate can be listed as follows:

  • During production work, production defects, various confusion and various contamination of the product are prevented.
  • In this way, the products are produced in healthy and hygienic conditions and presented to consumers.
  • In domestic and foreign markets, the producer company has achieved competitive advantage.
  • Increased reliability in the company's products for consumers
  • New demands of consumers in the future will be met quickly and on time
  • Compliance with domestic and foreign legal regulations
  • This situation naturally prevents the iron companies from falling into possible criminal situations.
  • Company employees' motivation is increasing and knowledge levels of good production practices are increasing.
  • Manufacturer and internal and external audits without any problems
  • Company's reputation and reputation in the market is rising

What is the Regulation on Good Agricultural Practices?

The Regulation on Good Agricultural Practices was published by the Ministry of Food, Agriculture and Livestock in 2010. While preparing this regulation, the following principles are emphasized:

  • Agricultural production in a way that does not pose a danger to human and animal health and environmental conditions
  • No damage to natural resources
  • Providing the principles of traceability and sustainability in agricultural activities
  • Always provide reliable and quality products to consumers

The regulation prepared in line with these objectives generally regulates the principles of Good Agricultural Practices and covers the general rules of this practice, control and certification procedures, duties and responsibilities of the producer companies, producer organizations and certification bodies.

The most important point in terms of certification work is that the certification body should be an accredited body within the scope of TS EN ISO / IEC 17065 (Conformity Assessment - Conditions for Product, Process and Service Certification). Certification may be on an individual basis or as a group.

Within the framework of the aforementioned regulation, certification studies are carried out on the basis of the following product groups: vegetable production (such as fruit and vegetables, field crops, flower and ornamental plants, seedlings and saplings and tea), animal production (dairy cattle, cattle fattening, poultry and turkeys). and aquaculture (fish and bivalve aquaculture).

As a result, Good Agricultural Practices are the adaptation of Good Manufacturing Practices to agricultural products.

Good Agricultural Practices in Pharmaceutical Industry

In terms of production and control of pharmaceutical products, Good Manufacturing Practices, quality control studies and quality risk management factors are of great importance. These elements have a fundamental importance for the production and control of pharmaceutical products. Accordingly, the drugs should be suitable for the information shown on the label and the drug should contain the correct substances in the correct proportions. The drug must be free of unwanted chemical, physical and biological impurities. Finally, the amount of active substance of the drug should be suitable for the intended treatment.

Good Manufacturing Practices in the production activities of drugs guarantee the following:

  • Product design and development in accordance with the principles of GLP, Good Laboratory Practice
  • Defining production and control processes in a clear language
  • Clear management responsibilities
  • Providing all intermediates, including raw materials, with proper principles, control and use for production
  • Supervision of the production of drugs by certain processes
  • Compliance with relevant legal regulations and controls for the placing of drugs on the market
  • Control of the storage and distribution processes of drugs

As a result, Good Laboratory Practice is a form of Good Manufacturing Practice adapted to the pharmaceutical industry.

The Relationship Between Quality Control Practices and Good Manufacturing Practices

Quality control practices are indispensably part of the GMP Good Manufacturing Practice. It is aimed to determine the quality of raw materials and the quality of the finished product before sales and distribution. Quality control studies include specification, sampling, testing and organization, documentation approval processes. Quality control studies are not limited to laboratory studies. Quality control is effective in making decisions about product quality. For this reason, a quality control study must be carried out at every point of production. For this purpose, opportunities should be provided by the manufacturer companies to ensure reliable and effective quality control activities. Mainly, quality control procedures should be performed and recorded in accordance with the written processes.

In this respect, for example in the pharmaceutical industry, drugs need to be produced with scientific and technological applications that will provide quality, safety and efficiency. The way to achieve this is to prove this situation. These validation studies are called validation. As a result, validation results are indicative of the quality of the drugs.

The data showing that a drug in the pharmaceutical industry is produced within the system of Good Manufacturing Practices include: the drug contains the right substance, contains the right substance at the desired rate, the right substance is the desired purity, the drug is produced by certain methods and properly produced, the drug is suitably packaged, properly packaged for the recognition of the drug, provided that it is properly maintained and the drug can always be obtained by these measurements and procedures.

Quality control workers are responsible for identifying, validating and implementing quality control processes, keeping the reference numbers of materials and products, ensuring the correct labeling of the products, monitoring the stability of the products and participating in the investigation of complaints about the products.

Quality control studies should also cover all relevant factors, such as the evaluation of the finished products, the test results of the production conditions and processes, the evaluation of the production documents, the suitability of the finished product properties and the examination of the product packaging.

The Importance of GMP Good Manufacturing Practice System Document

The GMP Good Manufacturing Practices System certification is a document proving that the products produced in sectors such as pharmaceuticals, medical devices and equipment, food and cosmetics are inspected and marketed safely. This document provides a quality approach for production activities and ensures the professional functioning of production in these sectors and ensures trust in the products.

During the certification studies, the manufacturer evaluates all aspects of production and every aspect of production. Production facilities, tools, materials and materials used, raw materials are high quality and reliable, production stages, employees and the environment of the enterprise are controlled separately. The GMP Good Manufacturing Practices System certification studies, primarily covering the pharmaceutical and food sectors, have also included the Cosmetic Law, the detergent and cleaning products into the cosmetics group and the cosmetic sector. Medical tools and equipment used in humans and animals are also included in the scope of application.

The certification bodies form a work program on demand from the manufacturing companies, and then carry out audit of the documents through the documentation work prepared by the manufacturer by assigning expert auditors. The second stage of the audit is carried out by monitoring the production activities in the production facilities of the manufacturer firmly. The certification body evaluates the manufacturer based on the auditor's reports and, if appropriate, submits the GMP Good Manufacturing Practice System certificate and submits it to the firm. The validity period of this document is three years, but at least once a year interim inspections are required at the manufacturer.

Good Manufacturing Practices in terms of Human Health

The globalization phenomenon is becoming increasingly important in the world, particularly in the pharmaceutical, health and food sectors, with the provision of products and services that meet quality and hygiene rules. The need for quality control and certification systems, which are important for human health, is the result of this. Nowadays, the organizations operating in the health sector are turning to GMP Good Manufacturing Practices, which includes advanced quality and hygiene control methods and documentation systems. Moreover, this system can be easily installed in the operating systems of the organization. Although the sector in which GMP Good Manufacturing Practices is first used is only the food sector, the awareness of human health protection has increased and this system has been used in all product and service producing organizations. Today the GMP Good Manufacturing Practices document in international trade has been questioned.

As is known, the ISO 9000 Quality Management System series includes standard around 20. But there are actually four basic quality systems:

  • ISO 9000 Quality Management Systems - Basic concepts, terms and recipes
  • ISO 9001 Quality Management Systems - Terms
  • ISO 9004 Quality Management Systems - Guide for performance improvements
  • ISO 19011 Guide for quality and environmental inspection

In addition, other management systems for quality, health and hygiene conditions have been developed for different sectors. For example,

  • ISO 14001 Environmental Management System
  • HACCP Hazard Analysis and Critical Control Points System
  • ISO 22000 Food Management System
  • OHSAS 18001 Occupational Health and Safety Management System
  • SA 8000 Social Responsibility System
  • ISO 16949 Automotive Sector Quality Management System
  • ISO 13485 and 13488 Medical Devices Management System
  • Integrated management system

All these standardization and quality management systems include applications for the protection of hygiene and quality on the basis of health, environment and different production areas, but on the basis of international standards.

Apart from these, standardization of quality systems such as Good Laboratory Practices and Good Clinical Practices has made serious progress in clinical studies today. Like this, there are other Good Manufacturing Practices which are used internationally. The following exemplary implementations vary according to the fields of activity and service areas and can be directed towards different occupational groups:

  • Good Agricultural Practices
  • Good Veterinary Practices
  • Good Hygiene Practices
  • Good Laboratory Practices
  • Good Distribution Practices
  • Good Trade Practices
  • Good Storage Practices
  • Good Clinical Practice

Good Manufacturing Practices is a quality control system that controls the processes of producing, storing, distributing and delivering products such as pharmaceuticals, food, cosmetics and veterinary drugs, and it can be easily applied to many different sectors as seen above.

The deterioration of the ecological balance in the world, the depletion of natural resources, the acquisition of food and to sustain it has begun to create great problems. In parallel with this, safe food expectations have started to increase in people and new applications have been started to be made. Good Agricultural Practices, Good Hygiene Practices or Good Manufacturing Practices are the result of these efforts.

The first of these is Good Manufacturing Practices. This application is the main application in the production and distribution processes of food products and contains a set of criteria which should be applied in the raw material, processing, product development, production, packaging, storage and distribution processes for quality production. In the European Union, the European Food Authority was established in 2003 and legally enacted the HACCP Hazard Analysis and Critical Control Points System, Good Hygiene Practices and Good Manufacturing Practices. This law is responsible for both the European Union countries, the candidate countries for the Union and the third countries engaged in trade with these countries.

In our country, legal regulations have been made within the framework of harmonization studies with the European Union and Turkish Food Codex has been established. This codex has been harmonized with Amerka Food and Drug Administration and European Union directives. In this way, our country's food system, HACCP standard and Good Manufacturing Practices, such as quality systems are applied to ensure the reliability approach.

Today, consumers are concerned about how healthy these foods can be. Conscious consumers are constantly questioning the stages in which foods are produced, how much residual material they contain, how much hygiene products the manufacturers meet, how much production tools they use are suitable for production, and how effectively companies are audited.

Safe food means that the nutrients are not lost in terms of the physical, chemical and microbiological properties of foods and they are suitable for consumption. Today, food security has gained a global dimension. On the one hand, on the one hand, on the one hand, global food security has gained social, economic and environmental importance for all producers and consumers in the world. Therefore, it is essential that the products maintain their natural characteristics in all processes from the producer to the consumer, and the GMP Good Production System has an important role in ensuring this.

 

Certification

The firm, which provides auditing, supervision and certification services to internationally recognized standards, also provides periodic inspection, testing and control services.

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