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).

Briefly about GDP

Wholesale distribution of medicinal products is an activity that includes the acquisition, storage, supply or export of medicinal products, except for cases where these actions are performed for the purpose of selling or dispensing medicinal products to residents or patients.

Good distribution practice (GPP) is the part of the quality assurance process that ensures that the quality of medicines is preserved at all stages of the supply chain: procurement, receipt, storage, export of medicines for human use. 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.

Objective of GDP

These guidelines set out appropriate measures to support wholesale distributors in their operations and to prevent falsified medicines from entering the legitimate supply chain. Compliance with these guidelines will ensure control of the distribution chain and the quality and reliability of medicines.

GDP value

Compliance with the requirements of the system prepared according to the recommendations of good distribution practices creates added value for the company:

all critical steps 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 illegal supply chain during storage and transportation of the product;
the change control system works;
medicines are purchased, stored, supplied or exported in compliance with GPP requirements;
clearly defined responsibility of managers;
the products would be delivered to the right recipients within an acceptable time frame;
traceability of records is ensured;
managed deviations and risks.

Good Distribution Practice (GDP) applies - sectors of activity

The service is intended for the part of the pharmaceutical sector that includes wholesale distribution, i.e.:

for transport and logistics companies transporting medicines;
companies engaged in mediation of medicinal products;
for wholesale distribution license holders and
to other persons engaged in wholesale distribution activities.

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.

Integrated management system

Good distribution practice requirements can be integrated with other management systems, such as a quality management system (according to ISO 9001 requirements), an information security management system (ISO/IEC 27001) and others.

You can find out more about the requirements of good distribution practice here: www.eur-lex.europa.eu

More about UAB "Sertika" management system certification process is presented in the document "Management system certification (conformity assessment) regulations" (here) and section „FAQ“ (here).

Do you have questions about management system certification?

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phone: +37060005550;
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In order for us to submit a proposal for certification, the initial information required for the application is:

What certification standard do you want?
Have you installed a system of the desired standard? If not, when do you plan to do it?
What services or product production do you want to certify?
How many people work in your company?
Do you have departments and where are they located?
Where is your office located?
How long and when do you want SERTIKA audit and compliance assessment results?

A

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Management systems certification and training

Irma Kulpavičienė
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vs@sertika.lt

Specialist

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