he main purpose of GDP is to control the distribution chain and to maintain the quality and integrity of the product. This includes preventing counterfeit medicines from entering the legal supply chain.
There are 3 categories of operational activities for this:
1) Storage control management, such as temperature conditions
2) Distribution control management
3) Import and export compliance
1) STORAGE CONTROL MANAGEMENT:
The storage and transport conditions are stated on the outer packaging. These conditions are defined during the drug development phase and active substances, which are a part of the registration dossier or the marketing authorization. A temperature range is defined in which the product is not affected.
Some products require additional environmental conditions, such as protection from light and maximum humidity. As a wholesaler, it is your responsibility to ensure that you store the medicines under the specified conditions during storage and transport.
2) DISTRIBUTION CONTROL MANAGEMENT:
Traceability from start to finish is a requirement of GDP. It is expected that you note down where the products come from and where they are going. This administration provides complete insight into the distribution chain of the products. In the event of an emergency, such as a recall, can be retrieved from these records where the specific batches went. And control of the distribution chain prevents counterfeit medicines.
3) IMPORT / EXPORT COMPLIANCE:
To be able to sell a product in a particular country, it must be approved in advance. You must prove that the product is effective and safe to use. This one approval is referred to as the marketing authorization. In addition, each country or zone can have its own requirements and regulations. Products intended for the European market must comply with European rules. In addition, products that are made in a third country, such as India, that produce for the Dutch market, must first be imported and analyzed by an EU laboratory with a GMP license and released by a Qualified Person, QP. Only then will it be accepted on the Dutch market. A GMP license is required for these types of import activities.