Good Distribution Practice of medicinal products must
be maintained at all stages of the pharmaceutical supply chain, right up to the
implementation of good dispensing practices in the pharmacy.
challenges of Good Distribution Practice
Import, wholesale and
distribution are essential yet delicate links in the pharmaceutical supply
In the same way that
Good Manufacturing Practice is an integral part of the pharmaceutical
manufacturing process, so the implementation of Good Distribution Practice
needs to be guaranteed at the wholesale distribution stage. Consistent
application of good practice at all stages of the distribution process means
that patients can be sure of the quality, efficiency and safety of the
medicinal products they need for their health.
Good Distribution Practice: update from 5 November 2013
The corrected version of the Guidelines on the wholesale Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) was published in the Official Journal of the European Union on 5 November 2013. The new guidelines replace those from 7 March 2013 and are applicable the day after publication.
This new version differs from the 1994 version in that it includes all parties involved in the distribution of medicinal products, such as exporters (even in free zones) and brokers. It deals with all those factors and areas that ensure a secure distribution chain and prevent falsified medicinal products from entering the chain.
What has changed in the new GDP?
Practice now requires:
- A quality
system which documents processes, risk-management principles and change
control, and which includes management of outsourced activities through the
auditing of contracting parties.
- Competent personnel,
adequately trained in GDP and working under the direction of a designated
responsible person with the necessary qualifications, authority and resources.
- Adequate and
appropriate premises and equipment so as to ensure proper, safe storage
conditions (temperature, cleanliness etc.) and to allow for correct implementation
of procedures: cold rooms, refrigerators, approved and calibrated measuring
devices with documented procedures; documentation of any deviations and
implementation of corrective and preventive actions (CAPA).
- Accessible documentation
that sets out processes, instructions, contacts and data. All procedures
and amendments must be approved, dated and signed.
- Qualified providers
and clients who are authorised to deliver medicinal products while
maintaining appropriate conditions for receipt and storage and meeting the
requirements for the destruction of expired products.
and management of complaints, returns, suspected falsified medicinal
products and recalls in line with written procedures.
activities that are well
defined and controlled, under the responsibility of the contractor Contracting
parties must be competent and qualified for the activity assigned to them.
- Self-inspections to monitor implementation of GDP.
conditions that are kept stable during transportation using
well-maintained vehicles and equipment. Approved equipment (cold chain shipping containers
or vehicles) must be used to transport heat-sensitive medicinal products, with
temperatures monitored and charted, and personnel trained in procedures and the
seasonal configuration of insulated
packaging. Cooling packs must not come into contact with the medicinal
provisions now apply to brokers involved in these activities.
An upcoming article
will examine in more detail the new Good Distribution Practice as it applies to
the transportation of pharmaceutical products in the cold chain.