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On July 17, 2011, the European Union opened a consultation period to amend the current Guidelines on Good Distribution Practice (GDP) of Medicinal Products for Human Use (94/C 63/03), which was first published in 1994.

The recently published new Directive 2011/62/EU (the new Guidelines on Good Distribution Practice (GDP) of Medicinal Products for Human Use), which amends Directive 2001/83/EC focuses on stringent controls to ensure safety across the supply chain and reducing the risk of counterfeit medicines or medical devices entering the legitimate supply chain.

In order to maintain the quality of the products and reduce supply chain risks, it is crucial to exercise control over the entire distribution supply chain by observing good manufacturing practice of medicinal products. The same level of quality of GMP licence holders should be maintained throughout the distribution network without any alteration.

The new Guidelines have been divided into 10 sections:

1. Quality Management
2. Personnel
3. Premises and Equipment
4. Documentation
5. Operations
6. Complaints, returns, suspected falsified medicinal products and medicinal products recalls
7. Contract Operations
8. Self-inspections
9. Transportation
10. Specific Provisions for brokers

1. Quality Management

a. Quality systems must include activities to ensure confidence that the product delivered is not adulterated during storage and/or transportation. 
b. A responsible person should be appointed by the management for each distribution site.
c. The quality system should be fully documented and its effectiveness monitored.
d. Outsourced activities should be controlled by the quality management system. The processes should also incorporate quality risk management and also include:

i. Assess prior to outsourcing operations, the suitability and competence of the other party to carry out the activity and checking authorisation status
ii. Define the responsibilities and communication processes for quality related activities of the involved parties
iii. Monitor and review the performance of the contract acceptor

e. The quality system should also include quality management review and risk management

2. Personnel

a. There must be sufficient competent personnel to carry out all the tasks, which are the responsibility of the wholesale distributor.
b. Individual responsibilities should be clearly understood by the individuals and recorded.
c. All personnel should be aware of the principles of GDP that affect them and should receive initial and continuing training relevant to their responsibilities.
d. The responsible person is responsible for approving the initial and continuous training programme for all personnel involved in distribution activities
e. Personnel should receive initial and continuing training relevant to their tasks, based on written standard operating procedures (SOPs). The RP should also maintain his/her competence in GDP through regular training.
f. All training must be documented and training records kept. 

3. Premises and equipment

a. The premises should be designed or adapted to ensure that good storage conditions are maintained.
b. There should be segregated areas, separated from saleable products.
c. Medicinal products not intended for the European Union market should be kept in segregated areas.
d. Suitable equipment and procedures should be in place to ensure adequate control of the environment of medicinal products during storage.
e. Storage areas should be temperature mapped under representative conditions and should take into account seasonal variations.

4. Documentation

a. Documents should be retained for a period stated in national legislation but not shorter than 5 years, and should be readily available.
b. Attention should be paid to maintaining the SOP system to ensure the use of valid and approved procedures.
c. Records must be kept either in the form of purchase/sales invoices, delivery slips, on a computer or in any other form, for any transaction in medicinal products received, supplied or brokered.

5. Operations

a. All actions should ensure that the identity of the medicinal product is not lost and that distribution of medicinal products is handled according to the specifications given on the packaging information.
b. The wholesale distribution should use all means available to ensure that the source of all arriving products is known and compliant with GDP guidelines to minimise the risk of falsified products entering the legal supply chain.
c. Purchase of medicinal products should be controlled by written procedures. The selection, qualification and approval of suppliers is an important operation. Hence due diligence should be carried out by the distributor to assess suitability, competence and reliability of the other party to supply medicinal products.

6. Complaints, returns, suspected falsified medicinal products and medicinal products recalls

a. There should be a written procedure in place for the handling of complaints.
b. Any complaint concerning a potential product defect or a potential falsified product should be recorded with all the original details and investigated. The national competent authority should be notified without delay.
c. Any suspected falsified medicinal products found in the supply chain should be immediately physically and securely segregated from legitimate medicinal products.

7. Contract Operations

a. When outsourcing activities, a written contract should be drawn up. Written contracts should be established for any activity likely to impact on GDP related activities. The contract should specify their responsibilities.
b. The Contract Giver is responsible for the activities contracted out.
c. The Contact Acceptor should have adequate premises and equipment, knowledge and experience, and competent personnel to carry out satisfactorily the work ordered by the contract giver.

8. Self-Inspections

a. Self-inspection should be conducted in order to monitor the implementation and compliance with GDP principles and to propose necessary corrective measures.
b. Audit of subcontracted activities should be a part of the self-inspection programme.
c. All self-inspection should be recorded and all reports should contain all the observations made during inspections.

9. Transportation

a. Adequate precautions should be taken to ensure that transport conditions guarantee the quality of the product.
b. Delivery drivers (including contract drivers) should be trained in the relevant areas of GDP.
c. Deliveries should be made directly to the address stated on the delivery note and must be handed into the care of the consignee. Medicinal products should not be left on alternative premises.

10. Specific Provisions for Brokers (emanating from amendment to Directive 2001/83/EC)

a. The quality system of a broker should be defined in writing.
b. Any member of personnel involved in brokering activities should be trained in the applicable EU and national legislation in the issues concerning falsified medicinal products.

Please note that this summary is not intended to serve as a comprehensive and formal interpretation or guidance.