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Consulting Good Manufacturing Practices GMP - Qualimark
Help companies in sectors such as pharmaceuticals and cosmetics apply GMP standards to standardize product quality and worker safety.
What is the GMP certification process?
GMP Good Manufacturing Practices treats the enterprise in all its aspects, They are the basic characteristics they must possess and the different standards for each production process. Determines and controls the quality and reliability of the production site, environment and instrument - equipment, production process, personnel and raw materials.
GMP covers the pharmaceutical, cosmetics and food sectors, This sector is also through the adoption of the Cosmetics Act, which provides for the acceptance of detergents and cleaning products in the category of "cosmetics."
It is a standard that includes preventive measures for the Organization's internal and external circumstances in order to prevent or reduce the possibility of contamination of the product from internal and external sources. This application is one of the basic methods in the production and distribution of food products, it is a series of techniques that should be applied continuously in the stages of raw materials, processing, product development, production, packaging, storage and distribution to ensure quality in the products.
When companies using the good GMP manufacturing system apply to the certification body, the contract is concluded first. Subsequently, the Certification Authority began its audit work. However, before certification studies begin, the company must have determined the workflow of each activity, prepared the business operations, and written the presentation instructions showing how the business is carried out. In addition, he must act in accordance with these prepared procedures during his activities.
Hygiene and hygiene are the most sensitive issues of the system. Cleaning rules should be established for places produced or served by the enterprise. Ventilation, heating and humidity conditions in these areas should be regularly determined and maintained at required levels. In addition, control records must be kept and inspectors must identify this situation.
Technical documents relating to the products are requested from the institution and a preliminary study on all documents prepared is initiated. In this preliminary study, after correcting apparent defects and errors, actual field inspections are carried out in the company's production facilities.
The necessary tests and analyses are carried out and the auditors prepare a report at the end of their studies and the certification body decides to obtain the certification of the GMP good manufacturing practices system based on this report. Otherwise, the entity is expected to correct any detected shortcomings and errors.
What documents are required to apply for GMP Good Practice System certificate?
Since safety is one of the most sensitive issues of all other management systems, it is the most important issue in GMP good manufacturing practices along with hygiene and all kinds of security measures such as fires, earthquakes, traceability and the like must be taken in relevant institutions.
During the logistics process, the whole process must be controlled from purchasing raw materials to producing and packaging fully so that products that directly affect human health such as medicines, tools, medical equipment, cosmetics and foodstuffs reach the end user.
In addition to all these inspections, reporting products that do not conform to technical specifications, taking precautions to prevent repeat errors, methods of correcting errors, receiving and resolving customer complaints, and ways of calling the product when necessary, are also within the standards of the GMP good manufacturing practices system. In the meantime, identifying internal audit methods for companies that have established this system in the said sectors and defining the principles of external auditing are among the requirements of this system.
When companies that adopt good manufacturing practices and produce accordingly, fill out the document application form, they start the certification process. When the certification body begins its audit work, it will be subject to documents that were previously available.
The criteria to be taken as a basis in the certification process were prepared by the Turkish Standards Institute, Chemical Industry Certification Directorate on the basis of guidance and certification standards prepared in accordance with these standards.
If the results are positive as a result of this process, the advanced company is entitled to GMP certification. The validity period of GMP certification is 3 years. However, companies are kept under control by conducting interim audits by the Certification Authority each year.
What is GMP good manufacturing practices system certification?
Good Manufacturing Practices-GMP is a series of preventive measures designed to produce products that directly affect human health, such as food, medicine, cosmetics and medical devices, under reliable conditions and regulations, and to prevent the possibility of contamination at every stage from product preparation to distribution and increase reliability.
According to the cosmetic regulations adopted by the European Union in 2010, adherence to good production practices in cosmetics will be mandatory for cosmetics production places in all member and nominated countries starting July 2013. Under the application to be introduced in 2013 in our country, both products and export will be offered for sale in our country. GMP certification will be required.
It deals with all aspects of the work, i.e. with its basic characteristics and different standards for each production process. Determines and controls the quality and reliability of the production site, environment and instrument - equipment, production process, personnel and raw materials. GMP, which covers the pharmaceutical, cosmetic and food sectors, also covers this sector through the adoption of the Cosmetics Act, which provides for the acceptance of detergents and cleaning products in the category of "cosmetics."
GMP (good manufacturing practices) can be translated into Turkish good manufacturing practices. GMP standards are also included in the legislation of many countries. Countries have developed GMP rules in their legislation.
On the Tokyo Stock Exchange, the GMP Good Production Practices System certification is issued by the Chemical Sector Certification Department which operates under the product certification center. This certificate is provided for products such as medicines, foodstuffs, cosmetics and medical devices that will be produced and exported in our country, as well as products of the same quality that will be imported and offered for sale in the local market.
As a result of tests, analyses and inspections, companies that apply the system correctly and achieve positive results can obtain the GMP Good Manufacturing Practices System certification.
Who can obtain GMP good manufacturing practices system certification?
In the production of pharmaceuticals and medical devices, the good manufacturing application system GMP, which is under the entire logistics process until the products reach the end user, focuses more on the production and distribution activities of food products.
It has been reported that in recent years, it has been reported that it should be implemented as a recommendation by the United States and EU members and that all food and health products should be produced under GMP conditions according to the required decisions. Then, all these rules were officially accepted by our country's Ministry of Health. GMP rules must be implemented and implemented in order to ensure the health of their individuals and to accept the world's work and production.
Since current cosmetic rules accept detergents and cleaning products in the cosmetic category, the principles of the GMP also cover the cosmetic industry. In this case, all food production companies, pharmaceutical companies and companies that produce medical devices and equipment used in humans, animals and cosmetics companies can obtain GMP good manufacturing practices system certification.
GMP's standards of good manufacturing practices have been regulated as a different standard especially for cosmetics and ISO 22716 standards for good cosmetics have been published. But the basis of this standard is again the GMP good manufacturing practices standard.
GMP's system of good manufacturing practices is applied not only to manufacturers and exporters in the above sectors but also to companies that import and sell these products from foreign countries.
As a result, it is necessary to comply with GMP standards in raw materials, product development, production, packaging, storage and distribution phases to ensure quality in these products.
Companies that create and manage the GMP good manufacturing practices system in their organizations must produce production according to system standards and operate according to specific business processes. They should use the right materials and use the right machinery and equipment during production. Everything used, including staff, should be regular and clean.
What are the benefits of the GMP system for good manufacturing practices?
The benefits of good manufacturing practices in GMP can be listed as follows.
- It also ensures compliance with legal requirements.
- In this way, there is less possibility of facing any penalty situation.
- Any customer requests for today or in the future can be met more quickly.
- Increases awareness of production safety among employees.
- Products are produced in the most accurate manner and under the right conditions and delivered to the user.
- This, of course, increases the image of the company's reliability in public opinion.
- The company creates an advantage in international trade.
- Because the system also has quality management system standards, all stages of production are followed and the product is provided to reach the user in a very healthy way.
- Related processes and staff are kept under control in order to prevent confusion and various errors during production. Gains competitive advantage in the market against its competitors.
- Employees' motivation increases and a sense of commitment to the company increases.
How to install GMP good manufacturing practices?
The best way to create a good GMP manufacturing practices system, which was created to set production standards for food, pharmaceutical, medical and cosmetic producing companies, is to obtain consultancy services from the certification institution.
GMP (good manufacturing practices) In other words, good manufacturing practices are a standard that includes preventive measures relating to the internal and external conditions of the organization in order to prevent or reduce the likelihood of product contamination from internal and external sources. This application is one of the basic methods in the production and distribution of food products, it is a series of techniques that should be applied continuously in the stages of raw materials, processing, product development, production, packaging, storage and distribution to ensure quality in the products.
The GMP good manufacturing practices system installation process can be included as follows.
The first thing to do is to determine the management structure and structure of the company's activity.
After this work, the company's organizational structure and staff qualifications will be determined.
In the third step, feasibility studies are conducted.
In the next step, workflow charts will be removed and application instructions prepared to determine work processes.
Documents prepared for standards of good manufacturing practices should be in GMP.
Hygiene and sanitation documents will then be prepared.
Environmental control and production control procedures will be prepared.
Machinery, equipment and raw materials used in production will be specified.
Business operations will be monitored and, if necessary, changes will be made and approvals will be obtained.
Storage, shipping and product distribution conditions will be determined.
Reporting of products that do not comply with technical specifications will be ensured, measures will be identified in order not to repeat errors and methods for correcting errors will be determined.
Systems will be established to receive and resolve customers' complaints.
If necessary, ways of recalling the product will be determined.
Finally, the way inspections are conducted will be determined from inside and outside the company.
Accreditation studies will be conducted behind the completion of all these studies.
What is GMP good manufacturing practices?
The basic principles of the GMP good manufacturing practices system can be listed as follows.
- Establishing Quality Management
- Staff structure and organizational structure
- Standard assurance in buildings, machinery, equipment and materials
- Documentation of business processes and application instructions
- Identification, processing, storage and distribution of principles for the introduction of raw materials
- Quality Control and Efficiency Tests
- Approval of all activities and identification of authorized persons
- Complaints and product recall systems
- Investigate errors and take precautions
- Storage samples, destroy problematic products or return
- Provide internal and external auditing
The principle of compliance with all these principles is to provide healthy conditions during the production of products that affect first-class human health.
Ensuring healthy conditions and production under good conditions can only be ensured by establishing and managing the GMP good manufacturing practices system.
What is the standard range of GMP good manufacturing practices system?
GMP's good manufacturing practices system treats an enterprise in all its aspects, which are the basic characteristics you should have and different standards for each production process. Determines and controls the quality and reliability of the production site, environment and instrument - equipment, production process, personnel and raw materials. GMP, which covers the pharmaceutical, cosmetic and food sectors, also covers this sector through the adoption of the Cosmetics Act, which provides for the acceptance of detergents and cleaning products in the category of "cosmetics."
The system's scope headings are as follows
- Organized
- Operations risk assessment
- Infrastructure and equipment
- Training and competence
- Good Manufacturing Practice
- Hygiene, cleaning and sanitation
- Maintenance and calibration
- Recall
What are the basic principles of GMP's good manufacturing practices system?
The quality management system forms the basic structure of the GMP system, which depends on the establishment of quality management, quality control and qualification tests as a first principle.
Since the topic concerns human health, the second fundamental principle of the system is to eliminate or reduce the risk of pollution from internal and external factors in products produced by companies involved in the production of food, medicines, cosmetics and medical tools.
In applying the GMP good manufacturing practices system to manufacturing companies in these sectors, some basic principles are followed. For example, the organizational structure and company staff will be repaired and the organizational structure will be established to provide the highest level of hygiene and staff will be trained in this direction.
The principles of the system can be listed as follows.
- quality management
- Staff and Organization
- Construction, Hardware, Equipment and Materials
- Documentation
- Introduction of raw product, product processing, storage and distribution
- Quality Control and Efficiency Tests
- Approval and authorization of all transactions
- Complaints and summons
- Investigation of errors, clinical follow-up of products produced after use
- Storage samples, problematic destruction, back products
- Internal and external oversight
