GMP CERTIFICATE (GOOD MANUFACTURING PRACTICES)
GMP (Good Manufacturing Practices), meaning Good Manufacturing Practices in Turkish, is the basic quality approach for a healthy production in the food and pharmaceutical industry, on the conditions under which products that directly affect human health should be produced. It deals with manufacturing companies with all aspects, not just employees or only products. In accordance with the Cosmetics Regulation adopted by the European Union in 2010, as of July 2013, compliance with Good Manufacturing Practices in Cosmetics will be required for all member and candidate countries´ cosmetic production sites. Within the framework of the application that will start in 2013 in our country, GMP Certificate will be sought both for the products to be sold in our country and for export.
The place of production, its relations with the environment, the machinery and equipment used, the production processes, the qualifications of the employees and the characteristics of the raw material used determine the quality and reliability of the all-in-one product. GMP is essentially 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 expression used here stands for "Current-GMP" and is used to mean "Dynamic Good Manufacturing Practices".
In addition to being a quality approach to production, it ensures the professional functioning of food industry personnel and ensures reliable and effective product supply. Identifies and controls the quality and reliability of the raw material. In addition to this situation, it is the whole of the necessary provisions for the production of medical products applied to humans and animals. GMP (Good Manufacturing Practices System), which covers production activities especially in the pharmaceutical and food sector, later included the cosmetics sector when the cosmetic law was adopted and detergents and cleaning products were accepted within the cosmetic class.
The fulfillment of the general requirements of the GMP is possible with the items 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 of the manufactured products after use
j- Storage of samples, destruction of problematic, returned products
k- Internal and external audit
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 to production, it ensures the professional functioning of food industry personnel and ensures reliable and effective product supply.
If the benefits of the Good Manufacturing Practices standard are listed as items;
* The management capabilities of the relevant organization on product quality and safety assurance are proven.
* Helps you identify and manage key business risks, ensuring your feed business benefits animals and people.
* You can prove to customers that the baits were produced using safe processes.
* It is ensured that every employee who manages the production or takes part in the production gains good production and operation habits.
* Risks regarding product quality and safety are minimized.
* Undoubtedly, one of the most important benefits of the GMP Certificate to the business is the reduction of costs by detecting the problems in a timely manner.
* The GMP Certificate helps to better understand and comply with the laws and regulations related to production.
* In addition to the marginal benefits it provides, many companies want to obtain a GMP certificate in order to gain prestige and reliability at both national and international levels.
Establishment Stages of the GMP System
Within the Turkish Standards Institute, GMP Certificate is issued by the Chemistry Sector Certification Directorate affiliated to the Product Certification Center, both for the products that will be produced and exported in our country, and for the products that will be imported foreign countries and sold in the domestic market.
If the establishment stages of the GMP system are summarized in articles;
* The first thing to be done will be to determine the management style and activity structure of the company.
* This study will be followed by determining the organizational structure and employee qualifications of the company.
* In the third step, feasibility studies are carried out.
* The next step will be the preparation of work flow charts and the preparation of application instructions. This study is carried out to determine business processes.
* Prepared documents must be in GMP Good Manufacturing Practices standard.
* Later, documents related to hygiene and sanitation will be prepared.
* Procedures for environmental control and monitoring in production will be prepared.
* The machinery, equipment and raw materials used in production will be determined.
* Job exam will be monitored and explained in detail and approved.
* The completed packaging will be placed to place the shipment and shipment.
* Planning for technically inappropriate plans, which should be planned to avoid re-reviews, and for review objectives.
* Systems for customer services and resolution will be established.
* Treatments that require product recall referrals.
* The method of auditing inside and outside the final system will be determined.
* Behind the completion of all this work, certification studies are carried out.
GMP document showing no indication of how milk rules will be applied. Some principles that must be followed (as stated) should be able to be given provable GMP. Having a company quality can accommodate GMP. It is the summary of the most effective and productive day consisting of the content of the GMP document.
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