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ROI CalculatorGDP, which stands for Good Distribution Practices, is a fundamental branch of GxP regulations that organizations operating in regulated industries such as life sciences must adhere to. Compliance with GDP is necessary if your organization is involved in the storage, shipping or handling of medicines in the pharmaceutical or biotechnology sector.
The purpose of Good Distribution Practices guidelines is to help ensure the integrity, safety and quality of medicines as they are moved physically from the manufacturer to patients. Complying with the guidelines of good distribution practices means strictly adhering to the 10 chapters of good distribution practice principles.
GDP is an essential method of working in the pharmaceutical industry and should be incorporated into your pharmaceutical QMS. The GDP processes were developed for preventing contamination, falsification, and other threats to the quality and integrity of pharmaceutical products, from APIs to FDFs, on their way along the supply chain to the patients.
Good distribution practice should be viewed as part of the greater GxP framework that helps govern the requirements of pharmaceutical businesses regarding quality and integrity. While good distribution practice is expected and required in the USA by FDA, the requirements for GDP enforcement and compliance have been developed in greater detail as an independent discipline in European legislation and guidelines.
A thorough understanding of Good Distribution Practice can be gained by looking at the ten chapters outlining GDP compliance made by the European Union (EU). These chapters represent the most complete and recognized standards of Good Distribution Practice expectations.
Quality management system: Application of a trustworthy and carefully documented QMS in compliance with GDP standards.
Personnel: Training and qualification of all employees in charge of supervising and issuing pharmaceuticals as per appropriate regulations.
Premises & equipment: Setting up standards for both storage and transportation facilities, such as temperature control, hygiene standards, among others.
Documentation: Keeping complete and accurate records of distribution activities, as well as records of dealt complaints and product recalls.
Operations: Outlining procedures for the receipt, handling, and dispatch of medicinal products, including quality control and the necessary security precautions.
Complaints, returns, suspected falsified medicinal products, and medicinal product recalls: Guidelines to be followed for handling customer complaints, product returns, and recalling of potentially hazardous products.
Outsourced activities: Ensuring that third parties users under contract such as transporters have their own GDP system.
Self-inspections: Conducting regular self-inspections to ensure compliance with GDP guidelines and taking corrective actions when necessary.
Transportation: Stating requirements for the transportation of medicinal products, including temperature control and safety.
Specific provisions for brokers: Addressing the duties and laws for brokers in the pharma supply chain. Brokers act as intermediaries in the pharma supply chain and make it possible to buy and sell medicines but never own any of them. Instead, brokers connect buyers and sellers, help negotiate contracts and play an important role in other parts of the distribution process.
As good distribution practice centers on impermeable control of risks within a practical and business-wide QMS, digitizing it into an eQMS is a crucial way to streamline and fulfil GDP compliance demands.
