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Good distribution practices (GDP)

Good distribution practices is a standard developed for the sourcing, processing, storage and transport of drugs and their active ingredients. Wholesale license and permit holders must meet Good Distribution Practices (GDP) requirements to ensure the quality, safety and security of medicinal products throughout the pharmaceutical supply chain. Since pharmaceuticals are products that directly affect public health, compliance with GDP standards is critical for all individuals and institutions in the supply chain. Any error or problem in the distribution process of drugs can prevent consumers from accessing the drug and cause counterfeit drugs to enter the market. Good Distribution Practices ensure that the quality and safety of medicines are maintained while avoiding such problems. Businesses that meet the requirements of these standards can obtain a Good Distribution Practices Certificate / GDP Certificate. You can learn more detailed information about the scope of the standard and the certification process from Aşan Danışmanlık.

Good Distribution Practices Purpose

GDP is a standard that provides quality assurance for medicines throughout the supply chain. It provides a tool to protect the drug delivery system from counterfeit, unapproved, illegally imported, stolen, non-compliant, mixed or misbranded pharmaceutical products. Distribution is an important activity in the integrated supply chain management of pharmaceutical products. Different individuals and organizations are responsible for the transportation, storage and distribution of such products. However, in some cases, an individual or organization is only involved in and becomes responsible for certain elements of the distribution process. The purpose of Good Distribution Practices is to help ensure the quality and identity of pharmaceutical products at all stages of the distribution process. These stages include procurement, purchasing, storage, distribution, transportation, repackaging, relabeling, documentation and record keeping.

The storage, sale and distribution of pharmaceutical products are generally carried out by various companies, institutions and individuals. GDP lays out appropriate steps to help fulfill the responsibilities involved in different aspects of the distribution process within the supply chain and to prevent counterfeit products from entering the market through the distribution chain.

Counterfeit pharmaceutical products are a real threat to public health and safety. It is therefore essential to protect the pharmaceutical supply chain against the penetration of such products. Weak spots in the distribution processes of pharmaceutical products provide a way for counterfeit and illegally imported, stolen and substandard drugs to enter the supply chain. This is a very important problem in both developed and developing countries. Today, the way such products enter the supply chain has become more and more complex, resulting in the development of thriving secondary markets around the world. The involvement of unauthorized persons in the distribution and sale of pharmaceutical products is another problem. Only a joint approach involving all parties involved in the supply chain can be successful in the fight against counterfeit pharmaceutical products and therefore all parties active in the market must take an active role in joint activities. Good Distribution Practices are the common point of all these goals.

Scope of Good Distribution Practices

All stakeholders involved in the distribution of pharmaceutical products have a responsibility to ensure the quality of pharmaceutical products and the integrity of the distribution chain. Therefore, GDP principles should be incorporated into national legislation and guidelines regarding the distribution of pharmaceutical products in a country or region as a way of setting minimum standards. Good Distribution Practices can be applied both to pharmaceutical products moving along the distribution chain from the manufacturer to the organization responsible for the distribution or supply of pharmaceutical products to the patient, and to products moving backwards in the chain. Product returns or recalls and donated pharmaceutical products must also comply with GDP policies.

All organizations involved in the distribution process should conduct due diligence in procedures related to traceability and recognition of security risks, adhering to the principles of Good Manufacturing Practice. To ensure the quality and safety of pharmaceutical products and to prevent patient exposure to counterfeit products, there must be cooperation between all parties, including governments, customs agencies, law enforcement, regulatory authorities, manufacturers, distributors and organizations responsible for the supply of pharmaceutical products to patients.

Good Distribution Practices (GDP) explains the basic principles regarding:

* Organization and management
* Employee
* Quality system
* Facilities and storage
* Tools and equipment
* Shipping containers and container labeling
* Dispatch and receipt
* Shipping and transit products
* Documentation
* Repackaging and relabeling
* Complaints
* Returned products
* Counterfeit pharmaceutical products
* Import
* Contract activities
* Self-checking

For more detailed information about the Good Manufacturing Practices GDP Certificate, you can contact Aşan Danışmanlık.


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