GMP Certificate (Good Manufacturing Practices)


GMP (Good Manufacturing Practices), meaning Good Manufacturing Practices in Turkish, is the basic quality approach in the food and pharmaceutical industry regarding the conditions under which products that directly affect human health should be produced and for a healthy production. It deals with manufacturing companies not only in terms of employees or products, but also in all aspects. In accordance with the Cosmetics Regulation adopted by the European Union in 2010, all member and candidate countries will be obliged to comply with Good Manufacturing Practices in Cosmetics as of July 2013. Within the framework of the application that will start in 2013 in our country, GMP Certificate will be sought for both products to be sold in our country and for export.

The production site, its relations with the environment, the machines and equipment used, the production processes, the qualifications of the employees and the characteristics of the raw material used all together determine the quality and reliability of the product. GMP is mainly one of the GxP (GoodxPractise) cycles. Especially in the United States, Good Manufacturing Practice (GMP) is more often replaced by the definition of "cGMP". The definition used here is the word "Current-GMP" and it means "Dynamic Good Manufacturing Practices".

In addition to being a quality approach in the name of production, it ensures the professional functioning of food industry personnel and ensures reliable and effective products. It defines and controls the quality and reliability of the raw material. In addition to this situation, it is the whole of the provisions necessary for the production of medical products applied to humans and animals. The GMP (Good Manufacturing Practices System), which covers production activities especially in the pharmaceutical and food sector, later included the cosmetics industry when the cosmetics law was adopted and detergents and cleaning products were also included in the cosmetics class.

Fulfillment of the general conditions of GMP is possible with the articles listed below:

a- Quality management
b- Personnel and organization
c- Building, equipment, equipment and materials
d- Documentation
e- Raw product entry, product processing, storage and distribution
f- Quality control and proficiency tests
g- Approval and authorization of all transactions
h- Complaints and recalls
i- Investigation of errors, clinical follow-up after use of manufactured products
j- Storage of samples, destruction of problematic, returned products
k- Internal and external control

What are the Benefits of GMP Certificate?

Good Manufacturing Practice guidelines provide guidance for manufacturing, testing and quality assurance to ensure that a food or pharmaceutical product is safe for human consumption. In addition to being a quality approach in the name of production, it ensures the professional operation of the food industry personnel and ensures the provision of reliable and effective products.
If the benefits of the Good Manufacturing Practices standard are listed in items;

* The management capabilities of the relevant organization in product quality and safety assurance are proven.
* Helps you identify and manage key business risks, ensures that your feed business benefits animals and humans.
* You can prove to customers that the feed is produced using safe processes.
* It is ensured that every employee who manages the production or is personally involved in production gains the good production and operation habit.
* Risks on product quality and safety are minimized.
* One of the most important benefits provided by the GMP Certificate to the business is undoubtedly that the costs are reduced by detecting the problems on time.
* GMP Certificate helps to better understand and comply with laws and regulations related to production.
* In addition to the marginal benefits it provides, many companies want to obtain GMP certification in order to gain prestige and reliability at both national and international level.

Establishment Stages of the GMP System

Within the Turkish Standards Institute, the Chemical Sector Certification Directorate affiliated with the Product Certification Center issues a GMP Certificate for products that will be produced and exported in our country and for products that will be imported from abroad and sold in the domestic market.

If the establishment stages of the GMP system are summarized in items;

* The first thing to do will be to determine the management style and activity structure of the company.
* Following this study, the organizational structure of the company and determining the employee qualifications will come.
* Feasibility studies are carried out in the third step.
* The next step will come with the preparation of work flow charts and application instructions. This study is carried out to determine business processes.
* The documents prepared must be in GMP Good Manufacturing Practices standard.
* Afterwards, documents regarding hygiene and sanitation will be prepared.
* Procedures for environmental control and monitoring in production will be prepared.
* Machinery, equipment and raw materials used in production will be determined.
* Business processes will be monitored and changes will be made if necessary and approvals will be obtained.
* The storage, shipment and distribution conditions of the products whose production is completed will be determined.
* The products that do not comply with the technical specifications will be reported, necessary measures will be determined to prevent the errors from being repeated, and the ways to correct the errors will be determined.
* Systems will be established to receive and resolve customer complaints.
* When necessary, methods of product recall will be determined.
* Finally, the method of auditing from inside and outside the company will be determined.
* Behind the completion of all these studies, certification studies will be done.

The GMP certificate is not a certification process that specifies compliance with rules and instructions on how to produce products. A GMP certificate can be issued to productions that are proven to be in compliance with some principles (as mentioned above). When a company establishes its quality program and production process, it can implement various systems to fulfill GMP requirements and can obtain GMP certification if it declares this conformity. It is the company´s responsibility to determine the most effective and efficient quality process established to obtain GMP certification.

“As EKOL Certification Body, we are with you and support you in the process of GMP (Good Manufacturing Practices) Certificate. You can contact us to have detailed information. "

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