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THAILAND THE NEW GDP (GOOD DISTRIBUTION PRACTICE) REGULATIONS

Posted on by Nicola Milano
13
Sep

From 2022, the Food and Drug Administration has strict control over production and storage. By making it into law this causes entrepreneurs, both raw material distributors and pharmaceutical factories, to adjust greatly.

Difference between Good Distribution Practice (GDP Medicine) and Good Manufacturing Practice (GMP)

Good Distribution Practice or GDP

  It is a standard that determines good hygiene in the delivery of medicines and health products (HEALTHCARE PRODUCT). There will be various criteria and methods. in product distribution From product selection, sourcing, storage to delivery to drug sales locations or those authorized to deliver. and transporting products to consumers

The objective is to secure and maintain product quality during distribution to customers.

  Another name that everyone is familiar with is GSDP (Good Storage and Distribution Practices) which is a system for organizing, storing, and transporting medicine according to WHO (World Health Organization) standards, which at the point of GSDP is used a lot in the system. international transport for the product to be safe until it reaches the customer’s hand

GSDP (Good Storage and Distribution Practices) documentation

Good Manufacturing Practice or GMP

  is a good method of producing food safely or basic requirements necessary for production and quality assurance for safety. for manufacturers to follow and give the manufacturer Can prevent and eliminate risks that may occur with pharmaceutical or food products. safely Does not cause toxicity, danger or insecurity to consumers.

  • Drug GDP (Good Distribution Practice) is various processes since selection Delivery and storage of products until they reach the consumer in order to make the products have quality and meet standards

GMP (Good Manufacturing Practice) is a production process that meets standards. To ensure safety for consumers

Importance of pharmaceutical GDP ( Good Distribution Practice )

Many countries have begun to adopt guidelines for the distribution of pharmaceutical products. The originating company has an expectation that the partner company will be certified with the GDP system or have applied the system. To help build confidence in the quality management system of pharmaceutical products. and stability under ideal conditions regularly according to Specification that has been registered

By controlling activities from transportation, storage, and treatment in accordance with GDP principles throughout product distribution, including delivery of raw materials to production plants. Production plant forwards to transportation system and transported to consumers

This principle is a good way to distribute medicines. In order to maintain and maintain quality for warehouses and distribution centers specifically for pharmaceuticals and this internationally accepted GDP regulation, it is required that distributors of pharmaceutical products comply with GDP standards.

The new GDP ( Good Distribution Practice ) regulations was came in effect on 1 January 2022

Many countries have already enforced their use. But there are names for the system that may be different. Thailand has adopted GDP principles from Singapore. and applied as a law related to drug distribution standards. (GDP) in Thailand

Drug GDP Requirements and Registration

Compliance with GDP guidelines applies to drug licensees, including modern drug production licensees. or a licensee to import or order modern medicine into the Kingdom (Including pharmaceutical chemicals) which does not include licensees selling all types of drugs. The regulations will provide a place to store medicines. Tools and equipment for distributing drugs in accordance with the rules, methods, and conditions for distributing modern drugs and allowing pharmacists to control compliance with the criteria, methods, and conditions for distributing modern drugs.

There will be related documents as follows:

1. Laws related to GDP principles, drug products, Thai FDA

There will be 3 documents related to the relevant criteria.

2. Reference standards for using the GDP system

Used as a reference as a guideline for the distribution process such as sourcing, purchasing, storing, distributing, transporting documents and guidelines for recording according to GDP principles. There are 2 versions of pharmaceutical products as follows: 

There will be criteria according to the requirements, criteria, methods, and conditions for distributing modern medicine 2021, divided into a total of 9 categories, including:

  • Section 1 Quality Management
  • Category 2 Personnel
  • Section 3 Buildings, premises and equipment
  • Section 4 Document system
  • Section 5 Operations
  • Section 6 Complaints, return of medicinal products, counterfeit medicines, and recall of medicinal products
  • Section 7 Hiring outside agencies
  • Section 8 Self-inspection
  • Section 9 Transportation

3. Doing GDP (Good Distribution Practice)

Assessment of the current status or potential of the organization How ready are they to follow the principles of Good Distribution Practice (GDDP)? And is it necessary to improve or develop in any additional areas? To raise standards in controlling and supervising pharmaceutical products to ensure quality and safety for use throughout the product chain. Must have the following documents:

All this is to prepare for the enforcement of the GDP Pharmaceutical Law (Good Distribution Practice) in Thailand for improving the health system, quality of medicines and health products. To meet international standards.

Source: TFDA, Tinnakorn Group

Nicola Milano