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

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

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DQS

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