Good Distribution Practice of medicinal products for human use

Official Journal of the European Union C 343/1
INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
EUROPEAN COMMISSION
Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use
These Guidelines are based on Article 84 and Article 85b(3) of Directive 2001/83/EC ( 1 ).

CHAPTER 4 — DOCUMENTATION

4.1. Principle
Good documentation constitutes an essential part of the quality system. Written documentation should prevent errors from spoken communication and permits the tracking of relevant operations during the distribution of medicinal products.

4.2. General
Documentation comprises all written procedures, instructions, contracts, records and data, in paper or in electronic form. Documentation should be readily available/retrievable.

With regard to the processing of personal data of employees, complainants or any other natural person, Directive 95/46/EC (1) on the protection of individuals applies to the processing of personal data and to the free movement of such data.

Documentation should be sufficiently comprehensive with respect to the scope of the wholesale distributor’s activities and in a language understood by personnel. It should be written in clear, unambiguous language and be free from errors.

Procedure should be approved signed and dated by the responsible person. Documentation should be approved, signed and dated by appropriate authorised persons, as required. It should not be hand-written; although, where it is necessary, sufficient space should be provided for such entries.

Any alteration made in the documentation should be signed and dated; the alteration should permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded.

Documents should be retained for the period stated in national legislation but at least five years. Personal data should be deleted or anonymised as soon as their storage is no longer than necessary for the purpose of distribution activities.

Each employee should have ready access to all necessary documentation for the tasks executed.

Attention should be paid to using valid and approved procedures. Documents should have unambiguous content; title, nature and purpose should be clearly stated. Documents should be reviewed regularly and kept up-to-date. Version control should be applied to procedures. After revision of a document, a system should exist to prevent inadvertent use of the superseded version. Superseded or obsolete procedures should be removed from workstations and archived.

Records must be kept either in the form of purchase/sales invoices, delivery slips, or on computer or any other form, for any transaction in medicinal products received, supplied or brokered.

Records must include at least the following information: date; name of the medicinal product; quantity received, supplied or brokered; name and address of the supplier, customer, broker or consignee, as appropriate; and batch number at least for medicinal product bearing the safety features.

Records should be made at the time each operation is undertaken.

CHAPTER 5 — OPERATIONS

5.4. Receipt of medicinal products
The purpose of the receiving function is to ensure that the arriving consignment is correct, that the medicinal products originate from approved suppliers and that they have not been visibly damaged during transport.

Medicinal products requiring special storage or security measures should be prioritised and once appropriate checks have been conducted they should be immediately transferred to appropriate storage facilities.

Batches of medicinal products intended for the EU and EEA countries should not be transferred to saleable stock before assurance has been obtained in accordance with written procedures, that they are authorised for sale.

For batches coming from another Member State, prior to their transfer to saleable stock, the control report referred to in Article 51(1) of Directive 2001/83/EC or another proof of release to the market in question based on an equivalent system should be carefully checked by appropriately trained personnel.

Last modified: Monday, 4 March 2019, 1:36 PM