2013/C 343/01 - Good distribution practices for medical products

2013/C 343/01 Good distribution practices for medicinal products for human use

The official mark of the Good Distribution Practice (GDP) legislation

  • European Commission Guidelines 2013 November 5 on good distribution practices (GDP) for medicinal products for human use (2013/C 343/01).

Overview of Good Distribution Practices (GPP).

Good distribution practice (GPP) defines the requirements that wholesale distributors must meet in order to ensure the quality of medicines and prevent falsified medicines from entering the legitimate supply chain. This includes purchasing, storing, and transporting medicinal products, ensuring that the products reach the right recipients within an acceptable period of time. Medicines are a special product, the improper storage, transportation, and use of which are dangerous to health and life, so its path from the manufacturer to the consumer must be strictly controlled to prevent low-quality drugs from entering the market.

Presentation of Sertika services

Certification procedures are carried out according to the basic model:

Certification audit steps

Good Distribution Practices (GPP) for the company

Adherence to the system developed according to the recommendations of good distribution practices creates added value for the company:

  • All major milestones and significant changes in distribution processes are documented and, where appropriate, validated;
  • The product remains of high quality and reliability and does not enter the illicit supply chain during storage and transportation of the product;
  • The operation of the change control system is ensured;
  • Medicines are purchased, stored, supplied or exported in compliance with GPP requirements;
  • Managers' responsibilities are clearly defined;
  • Delivery of products to recipients within an acceptable period is ensured;
  • Traceability of records;
  • Deviations and risks are managed.

Customer benefits of Good Distribution Practices (GPP)

Customers of companies that comply with the GPP requirements receive the following benefits:
  • Confidence in the manufacturer and service provider is increased;
  • Compliance with legal requirements is ensured;
  • Quality services and products;
  • Transparency and traceability;
  • Competitive advantage when offering or supplying products to the European Union or other countries.

Which sectors are covered by Good Distribution Practice (GPP)

The service is intended for the part of the pharmaceutical sector that includes wholesale distribution:
  • For transport and logistics companies transporting medicines,
  • For companies engaged in mediation of medicinal products,
  • For holders of wholesale distribution licenses and
  • For other persons engaged in the activity of wholesale distribution.

Basic legal requirements for compliance. What are the legal requirements?

  • European Commission Guidelines 2013 November 5 on good distribution practices for medicinal products for human use (2013/C 343/01).

  • DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND COUNCIL of 2001 November 6 on the Community code relating to medicinal products for human use.

  • DIRECTIVE 2011/62/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 2011 June 8 amending Directive 2001/83/EC on the provisions of the Community code relating to medicinal products for human use as regards the prevention of falsified medicinal products entering the legitimate supply chain.

  • The Minister of Health Protection of the Republic of Lithuania in 2014 May 5 order no. V-524 "On conducting pharmaceutical activities in accordance with the good distribution practice of medicinal products".

  • The Minister of Health Protection of the Republic of Lithuania in 2014 July 3 order no. V-762 "On approval of the description of the inspection procedure for wholesale distribution license holders and distributors and importers of active substances to the requirements of Good Distribution Practice and the description of the procedure for issuing Good Distribution Practice certificates".

  • Pharmaceutical Law of the Republic of Lithuania of 2006 June 22 No. X-709 (Valid summary version from 05/26/2021).

  • International Conference on Harmonization of Technical Requirements for the Registration of Medicinal Products for Human Use (ICH Q9 Quality Risk Management) Guidelines Q9.

  • Technical regulations of the WHO organization.

Is it possible to integrate the Good Distribution Practice (GPP) guidelines with other standards?

The guidelines on good distribution practices for medicinal products for human use (2013/C 343/01) can be integrated into one effectively managed system together with the following standards:

  1. ISO 9001 - quality management system standard. Integration with ISO 9001 helps organizations ensure that their drug distribution processes are managed to high quality standards, consistently and efficiently.

  2. ISO 13485 - quality management system standard for medical devices. The integration of this standard is important for organizations that distribute medical devices, ensuring that their operations meet high quality and safety requirements.

  3. ISO/IEC 17025 - competence and quality standard for laboratories. If the organization performs laboratory tests and analyzes for drugs, the integration of this standard helps to ensure that these processes are carried out reliably and with high quality.

  4. ISO/IEC 27001 - information security management system standard. The integration of this standard is important, especially with regard to sensitive drug information, to ensure its security and confidentiality.

  5. ISO 31000 - risk management standard. Integration with this standard helps organizations identify and manage risks associated with drug distribution, thus ensuring high operational efficiency and safety.

You can find more about the integrated quality management system in the section: "Integrated quality management system".

Frequently Asked Questions (FAQ)

Here we provide answers to frequently asked questions about our ISO 50001 certification process, its duration, costs and other important information.

Where to start the certification process?

In order for us to submit an offer, please fill out the application and send it by e-mail: vs@sertika.lt;

Link to download the application

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