Project Description

Pharmaceutical GDP Certification

The pharmaceutical products normally have specified shelf life and storage conditions, in varying dosage forms, such as tablets, syrups, and injectables. Some medicines should be stored at temperature between 2 to 8 oC, in name of cold chain. It’s challenging to ensure consistent quality management throughout the supply chain for medicinal products .

Good Distribution Practices (GDP) is a quality system for distributors of and logistic companies for medicines, such as warehouses and forwarders. Some National Pharmaceutical GDP regulations may require pharmaceutical products distributors to comply with such standards.

Typical GDP Standards

  • EU GDP Guidelines (2013/C 343/01)
  • United States Pharmacopeia (USP 1079), and
  • WHO GDP (World Health Organization TRS 957 Annex 5)

Applicability

The Good Distribution Practices (GDP) guidelines are applicable to the storage and distribution of pharmaceutical products from the premises of the manufacturer of the product to the person dispensing or providing pharmaceutical products directly to patients or their agents.

Requirements for Wholesale Distributors

According to Article 1(17) of Directive 2001/83/EC, a medicinal products wholesale distributor has to hold a wholesale distribution authorisation. Article 80(g) of Directive 2001/83/EC provides that distributors must comply with the principles of and guidelines for GDP. Manufacturers performing any distribution activities with their own products must therefore comply with GDP.

Requirements for Logistic Service Providers

The EU GDP Guidelines include requirements for transportation and storage. EU Directive 2013/C343/01 requires that the contract giver is responsible for assessing the competence of the contract acceptor to successfully carry out the work required and for ensuring by means of the contract and through audits that the principles and guidelines of GDP are followed.

Audit & Certification

A GDP audit is based on a series of criteria, including quality control, employee training, security, inspection procedures, cleanliness of facilities, etc.

A certification against international GDP requirements with professional audits by a certification body will help you tackle the compliance with GDP guidelines with a systematic approach.

Benefits

  • Improved protection of high-value goods
  • Systematic reduction of liability risks
  • Strengthen customer confidence through transparency
  • Potential for synergies with ISO standards

Related News

DQS

DQS can provide audit, certification, and training service against the GDP standards. Contact us about the service that you need.

Related News

Pharma GDP Certification for WFS 為環美航務提供醫藥良好分銷規範認證

October 29th, 2019|Comments Off on Pharma GDP Certification for WFS 為環美航務提供醫藥良好分銷規範認證

Pharma GDP Certification for WFS World Flight Services (WFS) has been awarded certification for Pharma GDP for its temperature-controlled pharma facilities in Johannesburg and Cape Town, following an audit of WFS’ cargo operations by DQS. [...]

GDP Certification to UPS

September 26th, 2019|Comments Off on GDP Certification to UPS

UPS announced on Aug 8, 2019 that its services for pharmaceutical shipping in Germany are Good Distribution Practice certified by DQS. GDP of medicinal products for human use Unlike typical packages, healthcare packages containing pharmaceuticals [...]

World Courier awarded Good Distribution Practice (GDP) certification by DQS

February 26th, 2018|Comments Off on World Courier awarded Good Distribution Practice (GDP) certification by DQS

World Courier, a global leader in specialty logistics and a part of AmerisourceBergen, recently announced that it achieved Good Distribution Practice (GDP) certification across its global network of 140+ offices. (Image source: DQS Holding GmbH) [...]