Good Distribution Practice (Drug Product)
| Basic data | |
|---|---|
| Title: | Guidelines on Good Distribution Practice of Medicinal Products for Human Use |
| Short title: | Good Distribution Practice |
| Abbreviation: | GDP |
| Type: | Guideline |
| Scope: | European Union |
| Legal matter: | |
| Issued on: | March 8, 2013 |
| Entry into force on: | September 7, 2013 |
| Last change by: | OJ C, No. 343, November 23, 2013, pp. 1-14 |
| Weblink: | EUR-Lex |
| Please note the note on the applicable legal version. | |
The Good Distribution Practice of medicinal products for human use (GDP) or "good distribution practice of medicinal products for human use " are guidelines published by the European Commission on March 7, 2013 and entered into force on September 7, 2013. You have two main goals. On the one hand, they are intended to help prevent counterfeit drugs from entering legal supply chains for drugs. On the other hand, they should help to ensure control of the distribution chain and thereby maintain the quality and integrity of pharmaceuticals.
The GDP is based on Articles 84 and 85b (3) of Directive 2001/83 / EC of the European Parliament . The guidelines on Section 1a of the Quality Assurance System of the Medicines Trade Ordinance (AM-HandelsV) are integrated into German legislation . It says “Companies and institutions must comply with the EU guidelines for 'Good Distribution Practice for Medicinal Products' […]”.
Chapter 1 - Quality Management
Chapter 1 prescribes a quality assurance system for wholesalers of pharmaceuticals. This system sets out the responsibilities, processes and the principles of risk management in relation to their activities. Quality risk management is a systematic process for evaluating, controlling, communicating and reviewing risks related to the quality of pharmaceuticals. It can be done both proactively and retrospectively.
The guidelines describe how pharmaceuticals are procured, stored, delivered to the right recipient within a satisfactory period and exported, records of the process sequences are created in a timely manner, and deviations from the quality criteria are documented and investigated. Unless deviations are found, appropriate corrective and preventive actions (should Corrective and Preventive Measures "CAPA") for correction are introduced or prevention. If contractors are used to carry out activities, their suitability and competence must be assessed. When working with contractors , responsibilities and communication processes must be defined, the performance of the contractor monitored and the implementation of changes and corrections checked. The managing directors are responsible for the quality assurance system .
Chapter 2 - Personnel
For wholesalers to operate, it is important that adequately trained personnel are available. This is to ensure that activities for which the wholesaler is responsible are actually and correctly carried out. A responsible person must be named at the wholesaler. This authorizes the involvement of suppliers and customers, as well as all outsourced activities that could have an impact on good sales practice.
Chapter 3 - Operation Rooms and Equipment
The wholesaler's premises, systems and equipment must be suitable and sufficient for the execution of the activities. They should be clean, dry and at a suitable temperature and ensure the proper storage and proper distribution of the medicinal products. Equipment used to monitor and control the drug storage environment should be regularly calibrated based on a risk and reliability assessment. The calibration of the devices should be based on a national or international measurement standard. Appropriate alarm systems should be in place to report deviations from the predefined storage conditions. The alarm levels should be set appropriately and equipment should be checked regularly to ensure that it is working properly.
Chapter 4 - Documentation
The written documentation of the quality assurance system and the activities is an essential part of the quality assurance system. This avoids errors due to verbal communication only and it is possible to plan and understand the relevant work processes in the distribution of pharmaceuticals.
The date, name of the medicinal product, the quantity received, delivered or conveyed, the name and address of the supplier, customer, intermediary or recipient and at least the batch number of the medicinal product bearing the safety features are the minimum information that must be included in the records .
Chapter 5 - Operation
The wholesaler should ensure that the identity of the medicinal product is not lost and that the medicinal products are wholesaled in accordance with the information on the outer packaging. In particular, it should use all available means to minimize the risk of counterfeit medicines entering the legal supply chain .
For incoming deliveries, the supplier must present a document (e.g. the delivery note ). It contains the time , name and pharmaceutical form of the medicinal product, batch number of the medicinal product, at least for the medicinal products that have the safety features, the quantity delivered, the name and address of the supplier and the recipient (here the actual address of the warehouse if this differs from that of the recipient differs) as well as any necessary transport and storage conditions. The actual storage location of a product should be recognizable at all times from the records.
Chapter 6 - Complaints, Returns, Suspected Counterfeit Medicines, Medicines Recalls
All complaints, returns, suspected cases of counterfeit drugs and recalls must be documented in writing . The documentation procedure itself should also be documented in writing. The competent authorities should have access to these documents upon request. These and those responsible in the company should have easy access to the documents. The documents should contain sufficient information on the dealers and directly supplied customers (addresses, telephone and / or fax numbers during and outside business hours, batch numbers of at least the products that have the legally required safety features, quantities supplied) as well as information on exported products and drug samples contain.
If returned drugs are to be released for sale again, the products must be assessed beforehand . All participants in the supply chain must work according to this procedure in order to be able to effectively combat counterfeit medicines.
Chapter 7 - Outsourced / Commissioned Activities
If the wholesaler wants to outsource activities to external companies, the activities that fall within the scope of the guideline on good sales practice must be precisely defined, coordinated and controlled. This avoids misunderstandings that could affect the integrity of the product. Client and contractor conclude a written contract . The duties of each party are clearly defined there.
Just as the wholesaler and the contractor have adequate premises, equipment, has expertise and experience as well as qualified personnel to perform the in order given activities have.
If the contractor would like to pass on tasks assigned to him to a third party, this must be evaluated and approved in advance by the client. The third party must be audited in advance by the client or the contractor. The third party must be provided with information relevant to them from the contractual relationship between the wholesaler and the contractor.
Chapter 8 - Self-Inspections
Compliance with the principles of good sales practice should be ensured through regular self- inspections. Corrective measures can be suggested if deviations are found. The self- inspection cannot replace audits carried out by external experts . External audits are not excluded, but can only support compliance with the guidelines.
Chapter 9 - Transportation
The supplying wholesaler is responsible for protecting the pharmaceuticals in terms of quality and integrity, including packaging, along the entire transport chain. He must ensure that the vehicles and devices used for the distribution, storage or handling of pharmaceuticals are suitable and equipped for the respective use. The procedure for adhering to the guidelines in the transport process including cleaning and safety precautions as well as for determining and responding to deviations should be documented in writing. This particularly applies to breakage, impairment and theft as well as compliance with the specified temperature conditions. The specified temperatures for drugs are specified by the manufacturer on the outer packaging of the drug. The temperature specifications should also be complied with when unloading, reloading or temporarily storing drugs. Interim storage times until the next stage of transport are to be minimized. Dealers and recipients of pharmaceuticals should be informed about deviations such as temperature deviations and damage during transport. The procedure for determining deviations should be documented.
Only vehicles and equipment reserved for this purpose should preferably be used when transporting pharmaceuticals. If this cannot be implemented, procedures should be in place to ensure that the quality of the pharmaceuticals is not impaired.
Medicines should only be delivered to the address given on the delivery note and to the attention of or to the premises of the recipient and should not be dispensed in other premises.
For deliveries outside of office hours, there should be written procedures and specific persons should be named. The stipulations from Chapter 7 are to be used if third parties are used in the transport.
Transport planning should be based on a risk-based approach. On the basis of this risk assessment, methods and devices for temperature management and control are selected and used. The devices should be regularly serviced and calibrated at least once a year.
Those used in transport containers should be such that they have no negative impact on the quality of products and reasonable protection from external influences and contamination ( contamination offer). The labeling of the containers is to be designed in such a way that sufficient information on the content and origin, handling and storage conditions and precautionary measures can be derived from it. This ensures that the products are correctly handled and secured at all times.
In the case of drug deliveries that are subject to special conditions, such as for narcotics or psychotropic substances, the process descriptions, risk assessments and equipment used, as well as the personnel, must be adapted accordingly. Additional control systems should be put in place. This particularly applies to temperature-sensitive products for which qualified material (e.g. thermal packaging, temperature-controlled containers or vehicles with temperature control) should be used. Customers should have access to the written documented procedural instructions as well as control results, deviation analyzes and initiated measures.
Chapter 10 - Special rules for intermediaries
If intermediaries are used to buy and sell drugs, the provisions for wholesalers apply to them analogously, with the exception that intermediaries do not procure, deliver or store drugs. Intermediaries are persons who carry out activities in connection with the purchase or sale of medicinal products that are not associated with physical handling and that consist of negotiating independently and on behalf of another legal or natural person . Intermediaries are obliged to register and must have a permanent address . They must provide their contact details in the Member State where they are registered and immediately notify the competent authority of any changes to this information .
Web links
- Guidelines dated November 5, 2013 for good distribution practice for medicinal products for human use . In: Official Journal of the European Union . C, No. 343, November 23, 2013, pp. 1-14.
Individual evidence
- ^ European Commission - DG Health & Consumers - Public health - Medicinal products for human use - Good distribution practice
- ↑ GMP-Expert Forum-pharmind ( Memento of the original from September 12, 2014 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice.
