Revised Good Distribution Practice (GDP) with new Consignment Stock Appendix

Transcription

1 Revised Good Distribution Practice (GDP) with new Consignment Stock Appendix May 2010

2 Index 1. Introduction 2. Principles 3. Glossary 4. Organization and Management 5. Personnel 6. Documentation 7. Procedures 8. Records 9. Premises and equipment 10. Receipt 11. Storage 12. Vehicles 13. Deliveries to Customers 14. Transportation and products in transit 15. Returns of non-defective medical device products 16. Emergency plans and recalls 17. Counterfeit 18. Internal audits Appendix: Consignment Stock 2

3 1. Introduction To maintain the safety and performance of medical devices and the quality of the service offered by distributors, Eucomed has developed these guidelines to provide distributors with recommendations on Good Distribution Practice. It is also hoped this guidance will serve as a model in other regions as well. General reference is made to the content of the relevant provisions outlined in the Medical Device Directives including amending Directive 2007/47/EC and Decision 768/2008/EC and Regulation EC 765/2008 (the latter two insofar as reasonably applicable to medical devices). Distribution is an important activity in the integrated supply-chain management of medical devices. Various people and entities ( economic operators ) are generally responsible for the handling, storage and distribution of such medical devices in the supply chain. 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 safety, performance and identity of medical devices at all stages of the distribution process. Furthermore as counterfeit products are a potential threat for public health and safety, it is essential to protect the legitimate supply chain also against penetration of such products. This document sets out appropriate steps to assist in fulfilling the responsibilities involved in the different aspects of the medical device distribution process and to avoid the penetration of counterfeits into the legitimate supply chain. The guidelines are intended to apply to all steps in the distribution/supply chain. The relevant sections should be considered by various role players as applicable to their particular role in the distribution process. The storage, sale and distribution of medical devices are carried out by various companies, institutions and individuals. The nature of some risks involved, however, is likely to be similar to those in the manufacturing environment, e.g. mix-ups, contamination and cross-contamination. Therefore, appropriate and effective process controls and quality assurance measures should be in place. However, as printed packaging materials, labels, leaflets and boxes could form an integral part of safe and compliant products (e.g. sterile medical devices, where for example, the package lid may also be part of the sterile barrier), this is part of the manufacturing process and therefore manufacturer s responsibility. The practice of repackaging or opening of cartons where tamper-evident security seals have been applied should normally be avoided for quality and safety reasons. Furthermore, measures should be taken to assure the continuing integrity of anticounterfeit systems such as holograms. 2. Principles The European medical device industry operates at a high level of quality assurance, achieving its objectives by establishing and maintaining quality management systems, which are typically certified to EN ISO 13485: 2003 and / or EN ISO 9001: 2000, for the design and manufacture of devices. This practice ensures that products released for distribution are of appropriate quality, fit for their intended purpose and compliant with regulatory requirements. All parties involved in the supply chain are expected to act with due care in relation to applicable requirements. 3

4 Different models for the distribution of medical devices are used in different countries and sometimes within the same country, for example, in the public and the private sector. These guidelines are intended to be applicable to all persons and outlets involved in any aspect of the distribution of medical devices from the premises of production to the end-user. Regardless of model, however, it is recommended that Quality management systems are established and maintained throughout the supply chain to ensure the quality of medical devices is not adversely affected during their distribution and to ensure that appropriate records are kept. To the extent their actions may affect compliance distributors of medical devices should ensure that the products they handle have been placed on the market in accordance with European and national legislation, bear the required conformity marking and are accompanied by required documents, that correct storage conditions are observed at all times, including during transportation and that contamination from other products is avoided. They should also ensure that there is adequate turnover and stock rotation and that where the distributor is responsible for stock levels these are appropriate to support demand. Products must be stored in appropriately safe and secure areas. In addition, the distributor s quality management systems should ensure that the right products are delivered to the right addressee within a satisfactory time period. Appropriate records proving the origin and destination of the products must be kept. Distributors should have an active role in the post market surveillance and vigilance systems, either by reporting conformity problems or incidents to the manufacturer, or by supplying all relevant information to the Competent Authority on sound demand. 3. Glossary The definitions provided below apply to terms and phrases used in these guidelines. Although an effort has been made to use standard definitions as far as possible, they may have different meanings in other contexts and documents. agreement Arrangement undertaken by and legally binding on parties auditing Systematic, independent, documented process for obtaining records, statements of fact or other relevant information and assessing them objectively to determine the extent to which specified requirements are fulfilled. authorised representative Any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specific tasks as laid down by the medical device legislation. batch / lot A defined quantity of medical products processed in a single process or series of processes so that it is expected to be homogeneous. 4

5 batch / lot number A distinctive combination of numbers and/or letters which uniquely identifies a batch, for example, on the labels, its batch records and corresponding certificates of analysis. consignment (or delivery) The quantity of medical devices supplied at one time in response to a particular request or order. A consignment/delivery may comprise one or more packages or containers and may include material belonging to more than one batch. 1 container The material employed in the packaging of a medical device. Containers include primary, secondary and transportation containers. Containers are referred to as primary if they are intended to be in direct contact with the product. Secondary containers are not intended to be in direct contact with the product. contamination The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or on to a starting material, intermediate or finished medical device during handling, production, sampling, packaging or repackaging, storage or transport. contract Business agreement for the supply of goods or performance of work at a specified price. counterfeit A counterfeit product is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and counterfeit products and may include products with the correct components or with the wrong components, thus misleading the end-user s expectations for original / genuine product. distributor Any natural or legal person in the supply chain, other than the manufacturer or the importer who makes a medical device available on the market. distribution The division and movement of medical devices from the premises of the manufacturer of such 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. economic operators Any manufacturer, authorised representative, importer and distributor. expiry date The date given on the individual container (usually on the label) of a product up to and including which the product is expected to remain within specifications, if stored correctly. It is established for each batch by adding the specified shelf-life to the date of manufacture. 1 For many medical devices consignment may mean the practice of physically holding products at the customer location, but title to the product not passing from manufacturer / distributor to purchaser and payment not being made until product is actually used. That case will be addressed in separate guidance attached hereto as Consignment stock 5

6 first expiry/first out (FEFO) A distribution procedure that ensures that the stock with the earliest expiry date is distributed and/or used before an identical stock item with a later expiry date is distributed and/or used; first in/first out (FIFO) A distribution procedure to ensure that the oldest stock is distributed and/or used before a newer and identical stock item is distributed and/or used. forwarding agent A person or entity engaged in providing, either directly or indirectly, any service concerned with clearing and forwarding operations in any manner to any other person and includes a consignment agent. good distribution practices (GDP) Guidelines for the distribution of medical devices as a tool to secure the distribution system from counterfeits, unapproved, illegally imported, stolen counterfeit, substandard, and/or misbranded products. health care entity A health care entity is the whole or part of a public or private facility, building or place, whether operated for profit or not, that is operated or designed to provide health care services such as diagnostic, medical, dental treatment or chronic or rehabilitative care including supply of medical devices to the end-user. importer Shall mean any natural or legal person established within the Community who places a medical device from a third country on the Community market. labelling Definition according MDD 93/42/EC as last modified by Dir. 2007/47/EC shall apply including indication of Authorized Representative. logistics provider A logistics provider is a person or entity that provides logistics services for part or all of the supply chain management functions for other entities (manufacturers or suppliers). Third party logistics providers are typically specialized in integrated warehousing and transportation services that can be customized according to the demands and delivery requirements of their customers. A logistics provider does not hold proprietary rights over the products they store or distribute. making available on the market Shall mean any supply of a product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge. manufacture All operations of purchase of materials and products, production, packaging, labelling, quality control, release, storage and distribution of medical devices, and the related controls. manufacturer The definition according to MDD 93/42/EEC shall apply. 6

7 medical device Definition according to MDD 93/42/EEC shall apply. product recall Shall mean any measure aimed at achieving the return of a medical device that has already been made available to the end user (decision 768/2008/EC). Product recall is a process for withdrawing or removing a medical device from the distribution chain or correcting it in the field because of defects in the product or complaints of serious adverse events to the product. The recall might be initiated by the manufacturer, importer, wholesaler, distributor or a responsible authority. product withdrawal Shall mean any measure aimed at preventing a medical device in the supply chain from being made available on the market. quality assurance Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that medical devices are of the quality required for their intended use. quality management system The organizational structure, responsibilities, procedures, processes and resources for implementing quality management. For the purpose of these guideline implementing quality management is taken to include both the establishment and maintenance of the system. quarantine The status of medical devices isolated physically or by other effective means while a decision is awaited on their release, rejection or reprocessing. serial number A distinctive combination of numbers and/or letters which uniquely identifies an individual medical device e.g. on the labels, its records and corresponding certificates of analysis. shelf-life The period of time during which a medical device, if stored correctly, is expected to comply with the specification. The shelf-life is used to establish the expiry date of each batch or individual device. storage The storing of medical devices up to the point of use. supplier A organization or person that provides products and/or services. validation Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined requirements. vehicle Vehicle refers to trucks, vans, buses, minibuses, cars, trailers, aircraft, railway carriages, boats and other means which are used to convey medical devices. 7

8 4. Organization and management The distributor or the organization to which the distributor belongs should be an entity that is appropriately authorized to perform the intended function in terms of the applicable legislation, and which can be held accountable for its activities. The distributor should purchase the products only from the original manufacturer or other authorized sources. Subsequently manufacturers should sell their products only to the authorized distribution network. This will help to ensure that only genuine products enter the supply chain. It should also be noted that a distributor could be considered a manufacturer and would be subject to the obligations of the manufacturer where he places a product on the market under his name or trademark or modifies a product or its intended use placed on the market in such a way that compliance with the applicable requirements may be affected. 5. Personnel A management representative should be appointed in each distribution location, who should have defined authority and responsibility for ensuring that a quality system is implemented and maintained on that site. He should fulfil his responsibilities personally regardless of possible partial and documented delegation to other qualified individuals. Such managers should be appropriately trained and experienced and should be retrained at appropriate intervals. Key personnel involved in the warehousing of medical devices should have the appropriate ability and experience to ensure that the products are properly stored and handled. Personnel should be trained in the duties assigned to them, particularly regarding vigilance, and records to be maintained. 6. Documentation Although the Medical Devices Directives themselves do not place a specific requirement on distributors with regard to any documentation from distributors, local law may differ. Distributors may also hold the position of an Authorised Representative or Importer, in which case they shall keep or in consultation with manufacturer make available at least the EC declaration of Conformity and the technical documentation at the disposal of national surveillance authorities. 7. Procedures The distributor s quality management system where voluntarily in place - should include written procedures appropriate to the different operations carried out by the distributor including vigilance, receipt and checking of deliveries, storage, cleaning and maintenance of the premises. This includes recording of the storage conditions, security of stocks on site and of consignments in transit, quarantine, withdrawals from saleable stocks, records, including 8

9 records of clients' orders, returned products, trends of recalls, pest control, etc. These procedures should be approved, signed and dated by the responsible person. The quality management system should include provisions that the manufacturer and/or Authorized Representative and/or importer and/or labelled entity (if different from above) 2, the appropriate national and/or international regulatory bodies, as well as other relevant competent authorities, should be informed immediately in case of confirmed or suspected counterfeit medical devices or in case where there is a reasonable suspicion that a medical device is not in conformity with medical device legislation. Such products should be stored in a secure segregated area and have to be clearly identified to prevent further distribution or sale. 8. Records Records should be made at the time each supply chain operation is carried out in such a way that all significant activities or events are traceable. Records should be clear and readily available. They should be retained for a minimum period of 10 years or expected lifetime of the product unless indicated otherwise by the supplier or by applicable national regulation. Records should be kept of each purchase and sale (including loan and consignment devices), showing the date of purchase or supply, name of the medical device, quantity received or supplied and name and address of the supplier or consignee. For transactions between manufacturers and distributors and between distributors, records should ensure the traceability of the origin and destination of product, for example by use of batch / lot and / or serial numbers, so that all the suppliers and consignees can be identified. Auto ID or RFID technologies will support these efforts and will allow tracking and tracing from manufacturer to end-user / patient. However, it is hoped that in future a uniform approach to tracking and tracing the flow of medical devices throughout Europe will become available, for example machine-readable information on the products. 9. Premises and Equipment Premises and equipment should be suitable and adequate to ensure proper conservation and handling of medical devices. Premises should be constructed and maintained so as to protect materials from potentially harmful influences or contamination. Environmental monitoring devices, where appropriate, should be calibrated. 10. Receipt Receiving bays should protect deliveries from bad weather during unloading. The reception area should be separate from the storage and shipping/dispatch area. 2 The addressee of such information (within the supply chain) is normally the person / organization who first places the medical device on the market as required on the labelling. This provision should cover cases, where neither the manufacturer, the authorized representative nor the importer are clearly indicated. 9

10 Deliveries should be examined on receipt, in order to check that containers are not damaged and that the consignment corresponds to the order. Medical devices subject to specific storage measures should be immediately identified and stored in accordance with manufacturers' instructions. 11. Storage Medical devices should normally be stored apart from other goods and under the conditions specified by the manufacturer, in order to avoid any deterioration by e.g. light, moisture or temperature. The storage areas should be sufficiently large and should have physically separated zones so that orderly, segregated storage, including quarantine is possible. Temperature and/or other environmental variables should be monitored and recorded periodically where appropriate. Storage areas should be cleaned and accumulated waste removed at regular intervals. The frequency and methods of cleaning the premises and areas should be recorded. Smoking, eating and drinking should be permitted only in segregated areas, and not in those areas used for storage and handling of the product. Adequate toilet and changing facilities should be provided. These should be isolated from the main storage area. Adequate precautions should be taken against spillage or breakage and contamination. There should be a system to ensure stock rotation (first in, first out or first expiration date), with regular checks that the system is operating correctly. Products beyond their expiry date or shelf life should be separated from usable stock and neither sold nor supplied. Medical devices with broken seals, damaged packaging, or suspected of possible contamination should be withdrawn from saleable stock, and if not immediately destroyed, they should be kept in clearly separated areas, so that they cannot be sold in error or contaminate other goods. 12. Vehicles Appropriate vehicles and equipment should be used, where possible, when handling medical devices. Where non-dedicated vehicles and equipment are used, procedures must be in place to ensure that the quality of the medical device will not be compromised. Appropriate cleaning should be performed, checked and recorded. 13. Deliveries to Customers Before making a medical device available on the market distributors shall verify that the medical device bears the Conformity marking, that it is accompanied by the required 10

11 documents and by instructions for use (if applicable) in a language which is required by local medical device law in a specific Member State. The medical device shall bear a type, batch or serial number or other elements of identification as well as name, trade name and address of the manufacturer or importer or authorised representative as the case may be. Medical devices should only be sold and/or distributed to persons or entities that are entitled to acquire such products as established by the applicable national, regional and international legislation. Proof of such authority must be obtained prior to the distribution of products to such person or entities. The supplier of medical devices should, prior to the distribution of such products, ensure that the person or entity, e.g. the contract acceptor for transportation of the medical devices, is aware of and complies with the appropriate storage and transport conditions. For all supplies to customers including other actors in the distribution chain a document must be enclosed, making it possible to ascertain the date, the name of the medical device, the quantity supplied, the batch and or serial number and the name and address of the supplier and addressee. Proof of delivery transactions should be used. 14. Transportation and products in transit Medical devices should be transported in such a way that: their identification is not lost; adequate precautions are taken against spillage, contamination or theft; they are secure and not subject to unacceptable degrees of heat, cold, light, moisture or other adverse influence, nor to attack by micro-organisms or pests; medical devices requiring controlled temperatures and storage should also be transported by appropriate means. The manufacturer should communicate all relevant conditions for storage and transportation to those responsible for the storage and transportation of medical devices. Such an entity(-ies) should ensure adherence to these requirements throughout transportation and at any intermediate storage stages. Transportation and storage of bulk products comprising highly dangerous and/or otherwise hazardous substances presenting special risks of abuse, fire or explosion should be stored in safe, dedicated and secure areas, and transported in safe, dedicated and secure containers and vehicles. In addition, applicable international agreements and national legislation should be complied with. 15. Returns of Non-defective Medical Device Products Non-defective medical devices which have been returned should be kept apart from saleable stock to prevent from further distribution until a decision has been reached regarding their disposal. Products which have left the care of the distributor should only be returned to stock if: 11

12 the goods are in their original and sealed containers and in good condition; it is known that the goods have been stored and handled under proper condition; the remaining shelf life or expiry period is acceptable; they have been examined and assessed by a person authorised to do so. This assessment should take into account the nature of the product, any special storage conditions it requires and the time elapsed since it was issued. Special attention should be given to products requiring special storage conditions. As necessary, advice should be sought from the manufacturer of the product; records of returns should be kept. A designated person should formally release goods to be returned to stock. Products returned to saleable stock should be placed so that the first in, first out, first expiry system operates effectively. any repackaging and relabeling operations should be considered manufacturing activities and should be limited as far as possible and appropriate controls, linked to the manufacturer s quality management system, should be implemented. Sterile medical devices which have been returned should not be re-distributed, if there is any doubt about their proper condition (including but not limited to control of intermediate storage, moisture, temperature or other adverse influence), since putting them into service would incur an inappropriate risk and liability in respect of patients, users or third parties. 16. Emergency Plans and Recalls (Field Safety Corrective Action) Related to post market surveillance and vigilance actions, all documentation concerning the demonstration of conformity of the product and the quality system established and maintained should be made available on request in consultation with manufacturer. A recall or withdrawal procedure should be described in writing. Any such operation should be initiated and carried out only after full consultation with the manufacturer and should be recorded at the time it is carried out. Records should be made available promptly to the manufacturer. Recall information should be shared with the appropriate national competent authority after consultation with the manufacturer. In order to ensure the effectiveness of the recall procedure, the system of recording of deliveries should enable all those involved in the supply chain to be identified and contacted. In the case of recall, distributors may decide in consultation with the manufacturer to inform either all their customers of the recall or only those having received the batch to be recalled. All customers to whom the product was distributed should be informed with the appropriate degree of urgency. This includes customers in other Member States. The field safety corrective action message should request that the recalled products be removed immediately from usable stock and stored separately in a secure area until they are disposed of in accordance with the manufacturers' instructions. 12

13 17. Counterfeit medical devices Counterfeit medical devices discovered in the distribution network should be immediately brought to the attention of the competent authorities as well as the manufacturer of the genuine product. Any counterfeit or suspected counterfeit medical device found in the supply chain should be segregated immediately from legitimate products and recorded. Such products have to be clearly identified and put under quarantine to prevent further distribution or sale. Upon confirmation of the product being counterfeit a formal decision should be taken on its disposal, ensuring that it does not re-enter the market, and the decision recorded. 18. Internal Audits Internal audits should be conducted and documented in order to monitor the implementation of and compliance with this guideline. 13

14 Appendix Consignment Stock Index 1. Introduction 2. Principles 3. Glossary 4. Agreement 5. Deliveries to Customers 6. Kits 7. Return of Products 8. Inspection of Returned Products 9. Storage Conditions 10. Stock use and Replenishment I

15 1. Introduction Many companies provide Consignment stock of medical devices to customers as a service to ensure the customers have adequate stock of products available on site for their use when required. Eucomed has developed these guidelines to provide the suppliers (both manufacturers and distributors) with general principles for controlling these consignments. They should be used in addition to the provisions of GDP where appropriate and applicable. Note: The stock may be consigned on a long term basis, or as a short term loan to satisfy immediate customer needs. 2. Principles Manufacturers and distributors have the responsibility to ensure that products supplied to customers on consignment are controlled and meet all the requirements of Medical Device Directives as amended and Decision 768/2008/EC and Regulation EC 765/2008 (the latter insofar as reasonably applicable to medical devices) are fully met. 3. Glossary The definitions provided below apply to the words and phrases used in these guideline. Although an effort has been made to use standard definitions as far as possible, they may have different meanings in other contexts and documents. consignment stock 1 Products which are owned by the supplier and stored on customer premises for their specific use when required. kit An assembled set of Medical Devices (implants and/or instruments) shipped to a customer for the purpose of carrying out a surgical operation. long term consignment Product which remains on customer premises for an extended period of time. short term consignment Product which is delivered to a customer for a limited number of medical interventions, and which is returned to the supplier immediately on completion of that medical intervention. 1 Consignment may also mean the quantity of medical devices supplied at one time in response to a particular request or order. See consignment or delivery in glossary of main Good Distribution Practice section. II

16 4. Agreement An agreement should be in place to clearly define the responsibilities of both parties (supplier and customer). The agreement should not specify pricing details, these to be specified in a separate document which may be amended within the agreement period (Contract). Where necessary the agreement should refer to any local regulations and laws which may apply. In the case of Long Term Consignments, the agreement should state the details of the products to be consigned (item references, descriptions and quantities), together with any special storage conditions and responsibilities on both sides, if required. These details may be redefined within the duration of the agreement to ensure that adequate stocks are available to the customer. The agreement should also define the terms for termination by either party. 5. Deliveries to Customers The supplier should take adequate precautions to ensure that the products are delivered to the customer in useable condition, and that all regulatory requirements are met. This includes the ability to trace the products even if they are no longer in their original packaging. 6. Kits When products are supplied as an assembled kit it should be adequately packaged. If applicable this shall include any trays or other products required to ensure that the supplied medical devices can be cleaned and/or sterilised by the end user prior to use (if necessary). Instructions for cleaning and sterilisation should also be supplied at the time of delivery. Kits supplied by distributors should have a configuration based on the recommendations of the manufacturer of the included products. 7. Return of products Products returned from consignment (including assembled kits) must be either in their original manufacturers packaging or cleaned prior to dispatch from the customer. A certificate of cleaning should be provided. Any product not returned from the customer at the end or termination of the agreement shall be charged to the customer at the price stated in the contract. Any product returned from the customer at the end or termination of the agreement which is not in a useable condition shall be charged to the customer at the discretion of the supplier. III

17 8. Inspection of returned Products The condition and expiry date of products returned from consignment should be verified by the manufacturer/supplier before returning to stock and made available for sale, or before sending to another customer as a new consignment. This verification should use the inspection methods established by the supplier/manufacturer and should be equivalent to the methods used for new products and be in line with the main GDP document. Traceability of the products should be re-established during the inspection process. 9. Storage Conditions The customer is to be responsible for ensuring that any instruments in consignment are adequately maintained, kept in good working order, and handled only be adequately trained staff. Traceability of products is to be maintained by the customer whilst they are at the customers premises. The customer is to be responsible for the correct storage (including any storage conditions to the product as specified by the manufacturer) whilst the products are on their premises, and will be responsible for any deterioration which may take place. 10. Stock use and replenishment The customer will be responsible for advising the supplier of stock use in a timely manner after consumption and for generating a Purchase Order for the items consumed. The supplier will be responsible for replenishing the stock of products in accordance with the terms of the agreement. Replenishment product shall be charged at the price as stated in the contract. IV