GDP - Good Distribution Practices Document
GDP GOOD DISTRIBUTION PRACTICES
GDP refers to the guidelines that regulate wholesale distribution activities in order to ensure that the integrity and quality of medicinal products are maintained from the manufacturer to the end user. Good Distribution Practices ; covers not only the distribution of finished products but also the storage of active pharmaceutical ingredients (API) and other ingredients before production, as well as their supply and transportation.
Good Distribution Practices are also of great importance for the safety and health of patients due to the complexity and fragmentation of the global supply chain. Thanks to GDP, it is possible to prevent the inclusion of counterfeit, unapproved, illegally imported, stolen, non-standard or misbranded products in the pharmaceutical distribution system. Therefore, failure to comply with GDP rules at any storage and transportation point will cause major problems in the long term.
Advantages of Good Distribution Practices
Correct implementation of GDP provides the following significant advantages:
• Medicines move in accordance with European Union (EU) regulations and permits throughout the supply chain.
• Thanks to Good Distribution Practices, medicines are always stored under the right conditions, including during transportation.
• Mixing with other products, contamination and spoilage of its content are prevented.
• Good Distribution Practices also ensure the creation of a sustainable and effective business volume related to medicines.
• The right products reach the right people at the right time.
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Good Distribution Practices (GDP) Scope
The basic articles of Good Distribution Practice published by the EC on 5 November 2013 with guideline number 2013/C 343/01 are:
1. Quality Management : Responsibilities, processes and risk management principles are established in line with a specific quality management system.
2. Personnel: Every personnel working in the business must be an expert in their job and receive the necessary training.
3. Facilities and Equipment: All equipment, fittings and facilities used in the process covering activities such as storage and transportation of products must meet the required conditions.
4. Documentation: All activities carried out within the business should be documented in electronic media so that retrospective checks can be made when necessary.
5. Operations: All operations must be carried out according to the information written on the packaging along with the product's features.
6. Complaints, Returns, Suspected Counterfeit Products and Product Recalls: Written procedures should be established regarding these issues; in addition, the necessary actions should be taken promptly in cases such as complaints, requests, registrations and notification of counterfeit products.
7. Outsourced Activities: When an organization integrated with GDP outsources a job, it must define the job correctly, control the job and act within the contract.
8. Internal Audits: Necessary controls must be carried out regularly within the business, and in addition, corrective / preventive actions must be taken.
9. Transportation: During transportation, the necessary conditions for the product (temperature, humidity, etc.) must be created within the appropriate framework. Any factor that will change the physical or chemical properties of the product must be prevented.
10. Special Provisions for Brokers: Real or legal persons who negotiate with other companies and/or individuals on behalf of the business must also be registered.
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Solution in GLP Good Distribution Practice Certificate: Kaliteturk Consultancy.
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