About Authors:
Middha Akanksha*, Kataria Sahil, Kukkar Vipin
Seth G. L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Akankshamddh@gmail.com
Abstract
Good Distribution Practice (GDP) deals with the guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption.
GDP regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.
Reference Id: PHARMATUTOR-ART-1456
Introduction
Good Distribution Practice (GDP) deals with the guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption.
GDP regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.
Objectives
· To increase the capacity (e.g. human resources, logistics, information) of the drug distribution system to provide reliable and efficient distribution services
· To ensure the establishment of and adherence to good distribution practices
· To ensure equitable distribution (and re-distribution where necessary) of drugs to all parts of the country
· To harmonise public sector drug distribution.
· To establish appropriate structures and systems at national and district levels which will ensure efficient distribution of essential drugs and secures access to these by the population.
· To deliver safe, quality and timely pharmaceutical and related medical supplies to support health care delivery in the country.
- Requisitioning to facilitate timely processing of requisitions.
- Procurement to ensure quality supplies are procured from reputable sources in a cost effective manner.
- Storage to ensure pharmaceutical and related medical supplies are stored according to Public Health standards and WHO good distribution practices.
- Distribution to facilitate safe, efficient and timely delivery of pharmaceutical and related medical supplies from within and outside of this department.
Strategies:
· Produce guidelines on good pharmaceutical wholesale and distribution practice
· Train sufficient numbers of staff required for drug distribution operations (in both public and private sector) and ensure the establishment of an appropriate system of monitoring and support supervision
· Produce guidelines, establish systems and incentives to promote, and introduce statutory controls as required to enforce, the equitable distribution of drug outlets
· Establish and maintain an efficient mechanism for the identification and redistribution of excess stocks in both government and non-government institutions
· Collaborate with all relevant parties in order to promote to the greatest extent possible the harmonisation of the public and private sector drug distribution networks.
Distribution is an important activity in the integrated supply-chain management of pharmaceutical products. Various people and entities are generally responsible for the handling, storage and distribution of such products. In some cases, however, a person or entity is only involved in and responsible for certain elements of the distribution process. The Objective of these guidelines is to assist in ensuring the quality and identity of pharmaceutical Products during all aspects of the distribution process. These aspects include, but are not limited to, procurement, purchasing, storage, distribution, transportation, repackaging, relabeling, documentation and record-keeping practices.
The distribution of medicinal products is an important activity in the integrated supply chain management. Today’s distribution network for medicinal products is increasingly complex and involves many players. The quality and the integrity of medicinal products can be affected by a lack of adequate control over the numerous activities, which occur during distribution and it is also necessary to address the threat that falsified medicinal products pose to the distribution channel. It is necessary to exercise control over the entire chain of distribution objectives by observing good manufacturing practice of medicinal products. This Policy ensures that products manufactured in, or imported are of the appropriate quality. This level of quality should be maintained throughout the distribution network without any alteration. Distribution is "all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public.
Any person engaging in the activity of a distributor has to be holder of a wholesale distribution authorisation.
Possession of a manufacturing authorisation shall include authorisation to distribute the medicinal products covered by the authorisation.
The definition of distribution is independent as to whether that distributor is established or operating in specific customs areas, such as in free zones or in free warehouses. All obligations related to wholesale distribution activities (such as exporting, holding, or storing) also apply to these actors.
Other actors, such as brokers, also may play a role in the distribution channel of medicinal products.
Guidelines should also be considered for implementation by, among others, governments, regulatory bodies, international procurement organisations and donor agencies, as well as all parties involved in any aspect of distribution of medicinal products.
(ec.europa.eu/health/files/.../2011-07_gdpguidline_ publicconsultation.pdf)
WHO published a document titled 'Good Distribution Practices (GDP) for Pharmaceutical Products' for commenting until the end of March. This guidance contains regulations on the following points:
- Quality management, organisation and personnel
- Premises and storage areas
- Transport vehicles, external packaging and labelling
- Distribution and shipping practice, documentation
- Repackaging and relabeling
- Complaints, recalls and returned products
- Imports and contracting
(europa.eu/health/files/.../2011-07_gdpguidline_ publicconsultation.pdf)
Principles for GDP
The first of these principles is that the products must have the appropriate quality. When a drug is first developed and launched on to the market, its quality is assured by the authorization for marketing. GDP Guidelines are in place to ensure that this quality is maintained throughout the remainder of the distribution chain (Mccormick, 2002)
Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Consultative Committee
The GMP/GDP Consultative Committee has two primary objectives:
- To advise and provide information to representatives of Professional and Trade Associations, the wider Department of Health and Other Government Departments (OGDs) with respect to aspects of Good Manufacturing Practice and Good Distribution Practice and the licensing of manufacturers and wholesale dealers.
- To provide a forum for consultation and discussion.
The Committee meet hold at least one meeting each year and include representatives from Inspection, Enforcement & Standards Division of the MHRA including Inspectorate and Licensing Groups, British Pharmacopoeia (BP) and Laboratory Services, Regulatory Advice and Divisional Secretariat. The committee also includes representatives from interested Trade Associations and Professional Bodies and wider Department of Health and other Government Departments.
The Committee meet to discuss:
- Regulatory and international matters related to GMP and GDP
- The performance of operation of the GMP/GDP Inspectorate and the Licensing Office for manufacturers and wholesalers
- Interpretation of the Principles of GMP/GDP by the Regulatory Authorities compliance by Licence Holders (in general) with GMP and GDP
- Technical aspects of GMP and GDP.
The Consultative Committee is an informal committee established to provide a dialogue between the MHRA and other Governmental departments, the Devolved Administrations, and relevant trade associations on matters relating to the manufacture and wholesale distribution of medicinal products for human use.
(mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/Good Distribution Practice/ Background /index.htm)
Membership
Membership of the Consultative Committee includes representatives from:
- National Assembly for Wales
- Department of Health, Social Services and Public Safety, Northern Ireland
- Scottish Office Home and Health Department
- Veterinary Medicines Directorate
- NHS Pharmaceutical Production Committee
- Association of British Pharmaceutical Industry
- Association of Commercial Specials Manufacturers
- Bio industry Association
- British Association of Chemical Specialities
- British Association of European Pharmaceutical Distributors
- British Association of Pharmaceutical Wholesalers
- British Association of Research Quality Assurance
- British Generic Manufacturers Association
- British Herbal Medicine Association
- Chemical Industries Association
- Ethical Medicines Industry Group
- Joint Professional Bodies QP Assessor Panel
- National Office of Animal Health
- Natural Medicines Manufacturers Association
- Pharmaceutical Quality Group
- Proprietary Association of Great Britain
- (mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/Good Manufacturing Practice /GMP-GDPConsultativeCommittee/index.)
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Chapter 1 Quality Management
Principle
Wholesale distributors must maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities. They should ensure that the quality of medicinal products and the integrity of the distribution chain are maintained throughout the distribution process.
All distribution activities should be clearly defined and systematically reviewed and all critical steps of distribution processes and significant changes should be validated. The quality system should incorporate quality risk management principles. The attainment of this quality objective is the responsibility of the organisation’s senior management and requires their leadership and active participation and should be supported by the commitment of staff.
Quality System
1.1 The system for managing quality should encompass the organisational structure, procedures, processes and resources, as well as activities necessary to ensure confidence that the product delivered is not adulterated during storage and/or transportation.
1.2 A responsible person should be appointed by the management for each distribution site, who should have defined authority and responsibility for ensuring that a quality system is implemented and maintained.
1.3 Senior management of the distributor should ensure that all parts of the quality system are adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities.
1.4 The size and complexity of distributor’s activities should be taken into consideration when developing the quality management system or modifying an existing one.
1.5 The quality system should be fully documented and its effectiveness monitored. All quality related activities should be defined and documented. A quality manual or equivalent documentation approach should be established.
1.6 The quality system should be organised in a way, that it reflects the size and structure of the organisation.
1.7 A change control system should be in place for management of changes to critical processes. This system should incorporate quality risk management principles.
1.8 The quality system should ensure that:
i) Medicinal products are procured, held, supplied or exported in a way that is compliant with the requirements of GDP;
ii) Management responsibilities are clearly specified;
iii) Products are delivered to the right recipients within a satisfactory time period;
iv) Quality related activities are recorded at the time they are performed;
v) Deviations from established procedures are documented and investigated;
vi) Appropriate corrective and preventive actions (CAPA) are taken to correct deviations and prevent them in line with the principles of quality risk management. (Commission guidelines on Good Distribution Practice of medicinal products for human use)
Management of Outsourced Activities
1.9 The quality management system should extend to the control and review of any outsourced activities. These processes should incorporate quality risk management and include:
i) Assessing prior to outsourcing operations, the suitability and competence of the other party to carry out the activity and checking authorisation status, if required;
ii) Defining the responsibilities and communication processes for quality related activities of the involved parties. For outsourced activities, this should be included in a written agreement between the contract giver and contract acceptor;
iii) Monitoring and reviewing of the performance of the contract acceptor, and the identification and implementation of any needed improvements on a regular basis.
Management Review and Monitoring
1.10 Senior management should have a formal process for reviewing the quality management system on a periodic basis. The review should include:
i) Measurement of achievement of quality management system objectives;
ii) Assessment of performance indicators that can be used to monitor the effectiveness of processes within the quality management system, such as complaints, deviations, CAPA, changes to processes; feedback on outsourced activities; self assessment processes including risk assessments, and audits; external assessments such as regulatory inspections and findings and customer audits.
iii) Emerging regulations, guidance and quality issues that can impact the quality management system;
iv) Innovations that might enhance the quality management system;
v) Changes in business environment and objectives.
1.11 The outcome of this management review of the quality management system should be timely and effectively communicated.
Quality Risk Management
1.12 Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of medicinal products. It can be applied both proactively and retrospectively.
1.13 Quality risk management should ensure that the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient. The level of effort, formality and documentation of the process should be commensurate with the level of risk.
(ec.europa.eu/health/files/.../2011-07_gdpguidline_ publicconsultation.pdf)
Chapter 2 Personnel
Principle
The establishment and maintenance of a satisfactory quality management system and the correct distribution of medicinal products relies upon people. For this reason, there must be sufficient competent personnel to carry out all the tasks, which are the responsibility of the distributor. Individual responsibilities should be clearly understood by the individuals and recorded. All personnel should be aware of the principles of GDP that affect them and should receive initial and continuing training relevant to their responsibilities (European commission).This person should be appropriately qualified: although a degree in Pharmacy is desirable, the qualification requirements may be established by the Member State on whose territory the wholesaler is located.
Responsible Person
2.1 The wholesale distributor must designate a person as Responsible Person. The Responsible Person should fulfil his/her responsibilities personally and should be permanently available. The Responsible Person should meet the conditions provided for by the legislation of the Member State concerned.
2.2 The written job description of the Responsible Person should define his/her authorisation to take the decisions with regard to his/her responsibilities. The wholesale distributor should give the Responsible Person defined authority, resources and responsibility needed to fulfil his/her duties.
2.3 The qualifications of the Responsible Person should meet the conditions provided by the legislation of the Member State concerned and should be appropriate to fulfil the assigned duties. A degree in Pharmacy is desirable. He/she should have appropriate competence and experience as well as knowledge and training on GDP.
2.4 The Responsible Person should carry out his/her activities personally in order to ensure the wholesale distributor can demonstrate GDP compliance and that public service obligations are met.
2.5 His/her responsibilities include, but are not limited to:
i) Ensuring that a quality management system is implemented and maintained;
ii) Focussing on the management of authorised activities and the accuracy and quality of records;
iii) Approving the initial and continuous training programme for all personnel involved in distribution activities;
iv) Coordinating and performing promptly any recall operations of medicinal products;
v) Ensuring that relevant customer complaints are dealt with effectively;
vi) Performing the qualification and approval of suppliers and customers;
vii) Authorising the return to saleable stock of any returned medicines;
viii) Approving any contract between the Contract Giver and the Contract Acceptor which specifies their respective responsibilities relating to wholesale distribution and/or transportation of medicinal products;
ix) Ensuring that self inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
x) Delegating his/her duties when absent and keeping appropriate records relating to any delegation;
xi) Being involved in any decision to quarantine or dispose of returned, rejected, recalled or falsified products;
xii) Ensuring that any additional requirements imposed on certain products by national Law are adhered
Other Personnel
2.6 There should be an adequate number, in respect of the scope of its activities, of competent personnel, involved in all stages of the wholesale distribution activities of medicinal products in order to ensure that the quality of the product is maintained.
2.7 The organisational structure of the distributor should be defined in an organisational chart. The responsibility, role and interrelationships of all personnel should be clearly indicated.
2.8 The responsibilities and roles of employees working in key positions to medicinal products quality should be defined in written job descriptions, in which the deputyship arrangements of employees are also laid out.
2.9 The duties placed on any individual should not be so extensive as to present unacceptable risk to product quality.
Training
2.10 All personnel involved in wholesale distribution activities should be qualified in GDP requirements by training and should have the appropriate competence and experience prior to commencing their tasks.
2.11 In addition, training should include aspects of product identification and avoidance of falsified medicines entering the supply chain.
2.12 Personnel dealing with medicinal products requiring more stringent handling such as hazardous products, radioactive materials as well as products presenting special risks of abuse, narcotics or psychotropic substances, or temperature sensitive products should be given specific training.
2.13 Personnel should receive initial and continuing training relevant to their tasks, based on
Written standard operating procedures (SOPs) and in accordance with a written training programme. The Responsible Person should also maintain his/her competence in GDP through regular training.
2.14 A record of all training should be kept, and the practical effectiveness of training should be periodically assessed and documented.
Hygiene
2.15 Appropriate procedures relating to personnel hygiene, relevant to the activities to be carried out, should be established and observed. Such procedures should cover health, hygiene and clothing.
2.16 The storage of food, drink, smoking materials or medication for personal use in the storage areas should be prohibited.
(ec.europa.eu/health/files/.../2011-07_gdpguidline_ publicconsultation.pdf)
Chapter 3 Premises and Equipment
Principle
Wholesale distributors must have suitable and adequate premises, installations and equipment, so as to ensure proper conservation and distribution of the medicinal products.
Premises
3.1 The premises should be designed or adapted to ensure that good storage conditions are maintained. They should be suitably secure, structurally sound and of sufficient capacity to allow for the safe storage and handling of the medicinal products. Storage areas should be provided with adequate lighting to enable all operations to be carried out accurately and safely.
3.2 Where premises are not directly operated by the wholesale distributor, a contract should be in place and the premises should be covered by a wholesale distribution authorisation.
3.3 There should be segregated areas designated for the storage of products awaiting further decisions as to their fate. These include any product suspected of falsification, returned products, rejected product, product awaiting disposal and recalled product. The appropriate degree of security should be applied in these areas to ensure that such items remain separate from saleable stock.
3.4 Medicinal products not intended for the Union market should be kept in segregated areas.
3.5 Where specific storage conditions are required, control should be adequate to maintain all parts of the relevant storage area within defined temperature, humidity or light parameters.
3.6 Special attention should be paid to the storage of products with specific handling instructions as specified in national law. Special storage conditions (and special authorisations) may be required for such products (e.g. narcotics).
3.7 Radioactive materials and other hazardous products, as well as products presenting special risks of fire or explosion (e.g. pressurized gases, combustibles, flammable liquids and solids) should be stored in a dedicated area(s) subject to appropriate safety and security measures.
3.8 Receiving and dispatch bays should protect products from prevailing weather conditions. There should be adequate separation between the receipt and dispatch areas and storage areas. Reception areas where deliveries are examined at receipt should be designated and suitably equipped.
3.9 Unauthorised access to all areas of the authorised premises should be prevented. Prevention measures would usually include, but not be limited to, a monitored intruder alarm system and appropriate access control.
3.10 Premises and storage facilities should be clean and free from litter and dust. Cleaning instructions and records should be in place. Cleaning equipment should be chosen and used in order not to be a source of contamination.
3.11 Facilities should be designed and equipped so as to afford protection against the entry of insects, rodents or other animals. A preventive pest control programme should be in place.
3.12 Rest, wash and refreshment rooms for employees should be adequately separated from the storage areas.
Temperature and Environment Control
3.13 Suitable equipment and procedures should be in place to ensure adequate control of the environment of medicinal products during storage. Environmental factors to be considered include, but are not limited to, temperature, humidity, and cleanliness of the premises.
3.14 Storage areas should be temperature mapped under representative conditions and should take into account seasonal variations. An initial mapping should be carried out prior to the commencement of use. The mapping exercise should be repeated according to the results of a risk assessment exercise or whenever significant modifications are made to the facility or the temperature controlling equipment. Temperature monitoring equipment should be located according to the results of the mapping exercise.
Equipment
3.15 All equipment used for storage and distribution of medicinal products should be designed, located and maintained to a standard which suits its intended purpose. Planned preventive maintenance should be in place for key equipment vital to the functionality of the operation.
3.16 Equipment used to control or to monitor the environment of the medicinal product, should be calibrated and their correct operation and suitability for purpose verified at defined intervals by the appropriate methodology.
3.17 Calibration of equipment should be traceable to a primary standard. Appropriate alarm systems should be in place to provide alerts when there are deviations from pre-defined storage conditions. Alarm levels should be appropriately set and alarms should be regularly tested to ensure adequate functionality.
3.18 Repair, maintenance, and calibration operations of equipment should be carried out in such a way that the integrity of the medicinal products is not compromised.
3.19 Adequate records of repair, maintenance and calibration activities for key equipment should be made and the results should be retained. Relevant pieces of equipment would include (but not be limited to) cold stores, refrigerators, thermo hygrometers, or other temperature and humidity recording devices, air handling units and any equipment utilised in conjunction within the onward supply chain.
Computerised Systems
3.20 Before a computerised system is brought into use, it should be confirmed as being capable of achieving the desired results.
3.21 A written detailed description of the system should be available (including diagrams where appropriate). This should be kept up-to-date. The document should describe the principles, objectives, security measures and scope of the system and the main features, how the computerised system is used and the way it interacts with other systems.
3.22 Data should only be entered into the computerised system or amended by persons authorised to do so.
3.23 Data should be secured by physical or electronic means against wilful or accidental damage. Stored data should be checked for accessibility, durability and accuracy.
3.24 Data should be protected by backing up at regular intervals. Back up data should be stored for a period stated in national legislation but at least 5 years at a separate, secure location.
3.25 Procedures to be followed if the system fails or breaks down should be defined. This Should include systems for the restoration of data.
Qualification and Validation
3.26 Wholesale distributors should identify what qualification and/or validation work is necessary to demonstrate control of key aspects of their activities. The scope and extent of such validations should be determined by a documented risk assessment approach. Validation activities should be planned and documented. The plan should specify acceptance criteria.
3.27 Prior to implementation and after any significant changes or upgrades, systems should be validated to ensure correct installation and operation.
3.28 A validation report should be prepared summarising the results obtained and commenting on any observed deviations. The principles of corrective and preventive actions (CAPA) should be applied where necessary. Evidence of satisfactory validation and acceptance of a process or piece of equipment should be produced and approved by appropriate personnel.
3.29 Re-qualification of equipment following repair or maintenance should be considered dependant on the scope of the changes made. Such decisions should be justified utilising a risk based approach.
(ec.europa.eu/health/files/.../2011-07_gdpguidline_ publicconsultation.pdf)
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Chapter 4 Documentation
Principle
Good documentation constitutes an essential part of the quality management system. Clearly written documentation prevents errors from spoken communication and permits tracing of batch history. Instructions, procedures, and records should be free from errors and each employee should have access to such instructions and procedures concerning his or her activities at any time.
General
4.1 Documentation comprises all written procedures, instructions, contracts, records and data, in paper or in electronic form.
4.2 Documentation should be sufficiently comprehensive with respect to the scope of the distributor’s activities and in a language understood by personnel. It should be written in clear and unambiguous language.
4.3 Documentation should be approved, signed and dated by appropriate authorised persons, as required. It should not be hand-written; although, where documents require the entry of data, sufficient space should be provided for such entries.
4.4 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.
4.5 Documents should be retained for a period stated in national legislation but not shorter than 5 years.
4.6 All documentation should be readily available.
4.7 Attention should be paid to maintaining the SOP system so as to ensure the use of valid and approved procedures. Documents should have unambiguous contents; title, nature and purpose should be clearly stated. Documents should be reviewed regularly and kept up-to-date. Version control should be applied to SOPs and superseded versions should be archived. After revision of documents a system should exist to prevent inadvertent use of the superseded versions. Superseded or obsolete SOP documents should be removed from workstations.
4.8 Records
4.9 Records must be kept either in the form of purchase/sales invoices, delivery slips, or on computer or in any other form, for any transaction in medicinal products received, supplied or brokered.
4.10 Records should include the following information: date; name of the medicinal product; quantity received, supplied or brokered; name and address of the supplier, broker or consignee, as appropriate; and batch number where required.
4.11 Records should be made at the time each operation is taken and in such a way that all Significant activities or events are traceable.
(ec.europa.eu/health/files/.../2011-07_gdpguidline_ publicconsultation.pdf)
Chapter 5 Operations
Principle
All actions taken by the distributor should ensure that the identity of the medicinal product is not lost and that wholesale distribution of medicinal products is handled according to the specifications given on the packaging information. The wholesale distributor should use all means available to ensure that the source of all arriving products is known to minimise the risk of falsified medicinal products entering the legal supply chain.
Any distributor, not being the marketing authorisation holder, who imports a medicinal product from another Member State, shall notify the marketing authorisation holder and the competent authority in the Member State to which the medicinal product will be imported of his intention to import that product. All key operations should be fully described in the quality management system in appropriate standard operating procedures.
Qualification of Suppliers
5.1 Wholesale distributors must obtain their supplies of medicinal products only from persons who are themselves in possession of a wholesale distribution authorisation, or who are in possession of a manufacturing authorisation which covers the product in question.
5.2 Where the medicinal product is obtained from another wholesale distributor, wholesale distributors must verify compliance with the principles and guidelines of good distribution practices by the supplying wholesale distributor. This includes verifying whether the supplying wholesale distributor holds a wholesale distribution authorisation.
5.3 Where the medicinal product is obtained from the manufacturer or importer, wholesale distributors must verify that the manufacturer or importer holds a manufacturing authorisation.
5.4 Purchase of medicinal products should be controlled by written procedures. The supply chain of medicinal products should be known and documented.
5.5 Appropriate qualification should be performed prior to any procurement. The selection, including qualification and approval of suppliers is an important operation. This operation should be controlled by a standard operating procedure and the results documented and periodically rechecked.
5.6 If the medicinal product is obtained through brokering, the wholesale distributor must verify that the broker is registered and complies with the requirements
5.7 Due-diligence should be carried out by the distributor when entering a new contract with new suppliers in order to assess the suitability, competence and the reliability of the other party to supply medicinal products. A risk based approach should be used for this purpose considering:
i) searches for the new supplier’s reputation or reliability and its authorised activities;
ii) Certain medicinal products are more likely to be target of falsification;
iii) Large offers of medicinal product which are generally only available in limited quantities;
iv) Out of range prices.
Qualification of Customers
5.8 Wholesale distributors must ensure they must supply medicinal products only to persons who are themselves in possession of the distribution authorisation or who are authorized or entitled to supply medicinal products to the public in the Member State concerned. Qualification of customers should be appropriately documented.
5.9 Checks and periodic re-checks may include (but are not limited to): requesting copies of customer's authorisations according to national law, verifying status on an authority website, requesting evidence of qualifications or entitlement according to national legislation.
5.10 Wholesale distributors should monitor their transactions and investigate any irregularity in sale patterns to avoid diversion of medicinal products at risks of being misused and to ensure fulfilling any public service obligation imposed upon them.
Marketing authorisation
5.11 Wholesale distributors wishing to distribute or distributing medicinal products in Member State(s) other than the Member State in which the marketing authorisation was granted should, on request, make available a copy of the marketing authorisation to the national competent authority. Where appropriate, the competent authorities will inform the wholesale distributor of any public service obligation imposed on wholesale distributors operating on their territory.
Receipt of Goods
5.12 The purpose of the receiving function is to ensure that the arriving consignment is correct, the medicinal products originate from approved suppliers and that they have not been damaged or altered during transportation.
5.13 Where medicinal products require special storage or security measures, they should be transferred to appropriate storage facilities immediately after appropriate checks have been conducted.
5.14 In the event of any suspicion of falsified medicinal product, the batch should immediately be segregated and reported to the national competent authority and, where applicable to the marketing authorisation holder.
5.15 Batches of medicinal products intended for the Union market should not be transferred to saleable stock before assurance has been obtained in accordance with written procedures, that they are authorised and released for sale for the market in question.
5.16 Distributors receiving medicinal products from third countries for the purpose of importation, i.e. for the purpose of placing these products on the EU market, must hold a manufacturing/import authorisation.
Storage
5.17 Medicinal products should be stored separately from other products and protected from harmful effects of light, temperature, moisture or other external factors. Particular attention should be paid to products where specific storage conditions are required.
5.18 Incoming containers of medicinal products should be cleaned, if necessary, before storage.
5.19 Warehousing operations should ensure appropriate and good storage conditions and allow the orderly storage of the various categories of medicinal products, products in quarantine, and released, rejected, returned or recalled products as well as those suspected to be falsified.
5.20 Steps should be taken to ensure stock rotation according to the expiry dates of batches of medicinal products.
5.21 Medicinal products should be handled and stored in such a manner as to prevent spillage, breakage, contamination and mix-ups. Medicinal products should not be stored directly on the floor.
5.22 Medicinal products beyond their expiry date or shelf life should be withdrawn immediately from saleable stock either physically or through other equivalent electronic segregation. Physical removal of unsuitable stock should be performed regularly.
5.23 Stock inventories should be performed regularly. Timings should be defined using a risk based approach. Irregularities should be investigated and documented.
Segregation of Goods
5.24 If required, medicinal products should be stored in segregated areas, which are clearly marked and their access restricted to authorised personnel. Any system replacing physical segregation such as electronic segregation based on a computerised system shall provide equivalent security and should be validated.
5.25 Segregation should be provided for the storage of rejected, expired, recalled or returned products and suspected falsified medicinal products. The products and the areas concerned shall be appropriately identified.
Destruction of obsolete Goods
5.26 Medicinal products intended to be destroyed should be appropriately identified, kept separately and handled in accordance with a written procedure.
5.27 Destruction of medicinal products should be in accordance with national or international requirements for disposal of such products, and with due consideration to the protection of the environment.
5.28 Records of all destroyed medicinal products should be maintained.
Picking
5.29 Controls should be in place to ensure the correct product is picked. The product should have an appropriate remaining shelf life when it is picked. It should be picked on a "first expired first out" (FEFO) basis. The batch number should be recorded, where required.
Packing
5.30 Products should be packed in a way to avoid breakage, contamination and theft. The packing should be adequate to maintain the storage conditions of the product during transport. The containers in which medicinal products are shipped should be sealed.
Delivery
5.31 Deliveries should be made only to customers appropriately authorised or entitled to receive medicinal products.
5.32 For all supplies to a person authorised or entitled to supply medicinal product to the public, a document must be enclosed to ascertain the date; name and pharmaceutical form of the medicinal product, batch number at least for products bearing the safety features, where required; quantity supplied; name and address of the supplier, name and delivery address of the consignee (actual physical storage premises, if different) and applicable transport and storage conditions. Records should be kept so that the actual physical journey undertaken by the product can be tracked.
Export
5.33 The export of medicinal products falls within the definition of "wholesale distribution” A person exporting medicinal products must thus hold a wholesale distribution authorisation or a manufacturing authorisation. This is also the case if the exporting wholesale distributor is operation from a free zone.
5.34 The rules for wholesale distribution apply in their entirety in the case of export of medicinal products, with the following exceptions:
a. The customer does not have to be holder of a distribution authorisation;
b. Moreover, where the medicinal product intended for exportation has been obtained directly from another third country, without the product being prior to that placed on the market (ie without prior import), the supplier does not have to bear a wholesale distribution authorisation.
5.35 If the medicinal product is supplied to a person in a third country authorized or entitled to supply medicinal products to the public, the rules for document enclosure apply as for supply of the medicinal product established
(europa.eu/health/files/.../2011-07_gdpguidline_ publicconsultation.pdf)
Chapter 6 Complaints, Returns, suspected falsified Medicinal Products and Medicinal Product Recalls
Principle
All complaints and other information concerning potentially defective medicinal products must be collected and reviewed carefully according to written procedures. A special assessment of returned medicinal product should be performed before any approval for resale. A consistent approach amongst all partners within the supply chain is required in order to be successful in the fight against falsified medicinal products. A system should be designed to recall products known or suspected to be defective from the market in a prompt and effective manner. Any return, rejection or recall operation should be recorded and records should be made available to the competent authorities.
Standard Operating Procedures for handling product recalls and other similar situations should be prepared, maintained, and implemented.
Complaints
6.1 There should be a written procedure in place for the handling of complaints. A distinction should be made between complaints about the quality of a medicinal product and those relating to distribution. In the case of a complaint about the quality of a medicinal product, the manufacturer and/or marketing authorisation holder should be informed without delay.
6.2 A person should be appointed for handling the complaints with sufficient supporting personnel to assist him/her.
6.3 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.
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