New gdp's for medicinal products

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It is of key importance that the quality and the integrity of the medicinal products are maintained during the entire supply chain from the manufacturer to the patient. Today’s distribution network for medicinal products is increasingly complex and involves many players. The revised guidelines, published today, lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain.
The revised guidelines introduce the following changes:

the maintenance of a quality system setting out responsibilities, processes and risk management principles in relation to wholesale activities;
suitable documentation which prevents errors from spoken communication;
sufficient competent personnel to carry out all the tasks for which the wholesale distributor is responsible;
adequate premises, installations and equipment so as to ensure proper storage and distribution of medicinal products;
appropriate management of complaints, returns, suspected falsified medicinal products and recalls;
outsourced activities correctly defined to avoid misunderstandings;
rules for transport in particular to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport;
Specific rules for brokers (person involved in activities in relation to the sale or purchase of medicinal products)
Drug Regulations has prepared a presentation summarizing the new GDP requirements for Medicinal Products.

Published in: Health & Medicine

New gdp's for medicinal products

  1. 1. This presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional. Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals. 3/29/2015 1
  2. 2.  This presentation will cover ◦ Regulations ◦ Major Developments ◦ Definitions ◦ Wholesale Distribution ◦ Quality Management ◦ Personnel ◦ Premises & Equipment ◦ Documentation ◦ Operations ◦ Complaints, Returns, SFMP, Recalls ◦ Outsourced Activity ◦ Self Inspection ◦ Transportation ◦ Special Provisions for Brokers 3/29/2015 2
  3. 3.  Distribution : Important activity in the integrated supply chain management.  Lack of adequate control can affect the quality and the integrity of medicinal products .  New EU Commission guideline ( March 2013) ◦ (94/ C 63 /03 )  These guidelines are based on Article 84 and Article 85(b)(3) of Directive 2001/83/EC of the European Parliament. 3/29/2015 3 Drug Regulations - Online Resource for latest information.
  4. 4.  Important to maintain Quality and the Integrity of the medicinal products during the entire supply chain from the manufacturer to the patient.  Distribution network for medicinal products is increasingly complex and involves many players.  Revised guidelines will assist wholesale distributors ◦ In conducting their activities and ◦ To prevent falsified medicines from entering the legal supply chain. 3/29/2015 4 Drug Regulations - Online Resource for latest information.
  5. 5.  The revised guidelines introduce following changes: ◦ Maintenance of a quality system setting out responsibilities, processes and risk management principles in relation to wholesale activities; ◦ Suitable documentation which prevents errors from spoken communication; ◦ Sufficient competent personnel to carry out all the tasks for which the wholesale distributor is responsible; 3/29/2015 5 Drug Regulations - Online Resource for latest information.
  6. 6. ◦ Adequate premises, installations and equipment so as to ensure proper storage and distribution of medicinal products; ◦ Appropriate management of complaints, returns, suspected falsified medicinal products and recalls; ◦ Outsourced activities correctly defined to avoid misunderstandings; 3/29/2015 6 Drug Regulations - Online Resource for latest information.
  7. 7. ◦ Rules for transport in particular to protect medicinal products against breakage, adulteration and theft, ◦ Ensure that temperature conditions are maintained within acceptable limits during transport; ◦ Specific rules for brokers (person involved in activities in relation to the sale or purchase of medicinal products). 3/29/2015 7 Drug Regulations - Online Resource for latest information.
  8. 8.  Wholesale distribution of medicinal products is "all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public.  Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned". 3/29/2015 8 Drug Regulations - Online Resource for latest information.
  9. 9.  Definition of wholesale distribution does not depend on whether that distributor is established or operating in specific customs areas. ◦ such as in free zones or in free warehouses.  Wholesale distributor needs to hold wholesale distribution authorization.  Distributors must follow Good Distribution Practices. ◦ Article 80(g) of Directive 2001/83/EC 3/29/2015 9 Drug Regulations - Online Resource for latest information.
  10. 10.  All obligations related to wholesale distribution activities (such as exporting, holding or supplying) also apply to these distributors.  Relevant sections of these guidelines should also be adhered to by other actors involved in the distribution of medicinal products. 3/29/2015 10 Drug Regulations - Online Resource for latest information.
  11. 11.  Other actors such as brokers may also play a role in the distribution channel for medicinal products.  According to Article 85(b), brokers are subject to ◦ Certain provisions applicable to wholesale distributors, ◦ As well as specific provisions on brokering. 3/29/2015 11 Drug Regulations - Online Resource for latest information.
  12. 12. ◦ Maintain a quality system setting out  Responsibilities,  Processes and risk management principles in relation to their activities . ◦ Clearly define and systematically review all distribution activities. ◦ Justify all critical steps and significant changes of distribution processes ◦ Validate the same when relevant 3/29/2015 12 Drug Regulations - Online Resource for latest information.
  13. 13. ◦ The quality system  Responsibility of management  Requires management leadership and active participation  Should be supported by staff commitment 3/29/2015 13 Drug Regulations - Online Resource for latest information.
  14. 14.  Quality System should encompass the ◦ Organisational structure ◦ Procedures ◦ Processes ◦ Resources ◦ Activities necessary to ensure confidence that the product delivered maintains  its quality  Integrity  remains within the legal supply chain during storage and/or transportation. 3/29/2015 14 Drug Regulations - Online Resource for latest information.
  15. 15.  Document and monitor the effectiveness of the Quality System.  Fully define and Document all quality system- related activities.  Establish a quality manual or equivalent documentation approach. 3/29/2015 15 Drug Regulations - Online Resource for latest information.
  16. 16.  Appoint a responsible person to implement and maintain a Quality System  Specify his authority and responsibility  Adequately resource all parts of the quality system with ◦ Competent personnel ◦ Sufficient premises ◦ Equipment ◦ Facilities. 3/29/2015 16 Drug Regulations - Online Resource for latest information.
  17. 17.  Developing & Modifying Quality System ◦ Consider size, structure and complexity of distributor’s activities  A change control system should be in place. ◦ Incorporate quality risk management principles, ◦ System should be effective. 3/29/2015 17 Drug Regulations - Online Resource for latest information.
  18. 18.  The quality system should ensure ◦ Compliance to GDP when Medicinal products are procured, held, supplied or exported ◦ Management responsibilities are clearly specified ◦ That products are delivered to the right recipients within a satisfactory time period; ◦ That records are made contemporaneously; 3/29/2015 18 Drug Regulations - Online Resource for latest information.
  19. 19.  The quality system should ensure that: ◦ Deviations from established procedures are documented and investigated; ◦ Appropriate corrective and preventive actions (commonly known as CAPA) are taken to correct deviations and prevent them in line with the principles of quality risk management. 3/29/2015 19 Drug Regulations - Online Resource for latest information.
  20. 20.  Extend the quality system to the control and review of any outsourced activities related to the ◦ Procurement ◦ Holding ◦ Supply ◦ Export of medicinal products 3/29/2015 20 Drug Regulations - Online Resource for latest information.
  21. 21.  These processes should incorporate quality risk management and include: ◦ Assessing the suitability and competence of the Contract Acceptor to carry out the activity ◦ Checking authorisation status, if required ◦ Defining the responsibilities and communication processes for the quality-related activities of the parties involved ◦ Monitoring and review of the performance of the Contract Acceptor ◦ The identification and implementation of any required improvements on a regular basis. 3/29/2015 21 Drug Regulations - Online Resource for latest information.
  22. 22.  Have a regular formal review of the quality system.  The review should include: 1. Measurement of the achievement of quality system objectives; 3/29/2015 22 Drug Regulations - Online Resource for latest information.
  23. 23. 2. Assessment of performance indicators that can be used to monitor the effectiveness of Quality processes such as  Complaints,  Deviations,  CAPA,  Changes to processes;  Feedback on outsourced activities;  Self-assessment processes including risk assessments and audits; 3/29/2015 23 Drug Regulations - Online Resource for latest information.
  24. 24. ◦ External assessments such as  Inspections,  Findings and  Customer audits; 3. Emerging regulations, guidance and quality issues that can impact the quality management system; 3/29/2015 24 Drug Regulations - Online Resource for latest information.
  25. 25. 4. Innovations that might enhance the quality system; 5. Changes in business environment and objectives.  Document each review in a timely manner  Communicate the outcome internally. 3/29/2015 25 Drug Regulations - Online Resource for latest information.
  26. 26.  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. 3/29/2015 26 Drug Regulations - Online Resource for latest information.
  27. 27.  The correct distribution of medicinal products relies upon people.  For this reason, there must be sufficient competent personnel to carry out all the tasks for which the wholesale distributor is responsible.  Individual responsibilities should be clearly understood by the staff and be recorded. 3/29/2015 27 Drug Regulations - Online Resource for latest information.
  28. 28.  Designate a person as Responsible Person.  Responsible Person should ◦ Meet the qualifications and all conditions provided for by the legislation of the Member State concerned. ◦ Have a degree in pharmacy (desirable) ◦ Have appropriate competence and experience ◦ Have knowledge of and training in GDP. 3/29/2015 28 Drug Regulations - Online Resource forlatest information.
  29. 29.  The Responsible Person should ◦ Fulfil their responsibilities personally ◦ Be continuously contactable.  The Responsible Person may delegate duties but not responsibilities. 3/29/2015 29 Drug Regulations - Online Resource for latest information.
  30. 30.  Have a written job description  Define authority  Provide authority  Provide Resources  Provide Responsibility needed to fulfil their duties  Should carry out their duties to ◦ Demonstrable GDP compliance ◦ To meet public service obligations 3/29/2015 30 Drug Regulations - Online Resource for latest information.
  31. 31.  The responsibilities of the Responsible Person include: ◦ Ensuring that a quality management system is implemented and maintained; ◦ Focusing on the management of authorised activities and the accuracy and quality of records; ◦ Ensuring that initial and continuous training programmes are implemented and maintained; 3/29/2015 31 Drug Regulations - Online Resource for latest information.
  32. 32.  The responsibilities of the Responsible Person include: ◦ Coordinating and promptly performing any recall operations for medicinal products; ◦ Ensuring that relevant customer complaints are dealt with effectively; ◦ Ensuring that suppliers and customers are approved; ◦ Approving any subcontracted activities which may impact on GDP; 3/29/2015 32 Drug Regulations - Online Resource for latest information.
  33. 33.  The responsibilities of the Responsible Person include: ◦ Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme ◦ Necessary corrective measures are put in place; ◦ Keeping appropriate records of any delegated duties; 3/29/2015 33 Drug Regulations - Online Resource for latest information.
  34. 34.  Have adequate number of competent personnel  The number of personnel required will depend on the volume and scope of activities.  Define organisational structure in an organisation chart.  Define the role, responsibilities, and interrelationships of all personnel.  Have written Job Descriptions for key positions 3/29/2015 34 Drug Regulations - Online Resource for latest information.
  35. 35.  Train all personnel on the requirements of GDP  Personnel should have appropriate competence and experience prior to commencing their tasks  Training should be based on ◦ Role of each personnel ◦ Written procedures ◦ Written training programme  Personnel should receive initial and continuing training  Responsible Person should also be trained 3/29/2015 35 Drug Regulations - Online Resource for latest information.
  36. 36.  Also train on ◦ Aspects of product identification and ◦ Avoidance of falsified medicines entering the supply chain  Have special training for products requiring stringent handling conditions ◦ Hazardous products, ◦ Radioactive materials, ◦ Products presenting special risks of abuse (including narcotic and psychotropic substances), and ◦ Temperature-sensitive products. 3/29/2015 36 Drug Regulations - Online Resource for latest information.
  37. 37.  Maintain a record of all training  Periodically assess effectiveness of training  Document the effectiveness assessment 3/29/2015 37 Drug Regulations - Online Resource for latest information.
  38. 38.  Establish procedures personnel hygiene  Procedures should be relevant to the activities being carried out.  Procedures should be observed  Procedures should cover health, hygiene and clothing. 3/29/2015 38 Drug Regulations - Online Resource for latest information.
  39. 39.  Premises should ◦ Be suitable and adequate ◦ Have suitable and adequate installations and equipment ◦ Ensure proper storage and distribution of medicinal products ◦ Be clean, ◦ Be dry and ◦ Be maintained within acceptable temperature limits. 3/29/2015 39 Drug Regulations - Online Resource for latest information.
  40. 40.  The premises should be ◦ Designed or adapted to ensure that the required storage conditions are maintained ◦ Suitably secure, structurally sound ◦ Of sufficient capacity to allow safe storage and handling of the medicinal products ◦ Provided with adequate lighting to enable all operations to be carried out accurately and safely 3/29/2015 40 Drug Regulations - Online Resource for latest information.
  41. 41.  Where premises are not directly operated by the wholesale distributor, a contract should be in place.  The contracted premises should be covered by a separate wholesale distribution authorisation. 3/29/2015 41 Drug Regulations - Online Resource for latest information.
  42. 42.  Store Medicinal products in segregated areas  Clearly mark the area and have access restricted to authorised personnel.  Physical segregation can be replaced by electronic segregation  Such systems should provide equivalent security  Such systems should be validated. 3/29/2015 42 Drug Regulations - Online Resource for latest information.
  43. 43.  Following products should be segregated physically or through an electronic system ◦ Products pending a decision as to their disposition ◦ Products that have been removed from saleable stock ◦ Product suspected of falsification ◦ Returned products. ◦ Medicinal products received from a third country but not intended for the Union market should also be physically segregated. 3/29/2015 43 Drug Regulations - Online Resource for latest information.
  44. 44.  Physically segregate ◦ Any falsified medicinal products ◦ Expired products ◦ Recalled products and ◦ Rejected products found in the supply chain  Apply appropriate security to ensure separation from saleable stock.  Clearly identify these areas 3/29/2015 44 Drug Regulations - Online Resource for latest information.
  45. 45.  Store following products in dedicated areas  Follow local legislation  Follow appropriate safety and security measure. ◦ Radioactive materials ◦ Other hazardous products, ◦ Products presenting special safety risks of fire or explosion  (e.g. medicinal gases, combustibles, flammable liquids and solids) 3/29/2015 45 Drug Regulations - Online Resource for latest information.
  46. 46.  Design Receiving and dispatch bays to protect products from prevailing weather conditions  Have adequate separation between the receipt and dispatch and storage areas  Have procedures in place to maintain control of inbound/ outbound goods  Designate & suitably equip reception areas where deliveries are examined following receipt 3/29/2015 46 Drug Regulations - Online Resource for latest information.
  47. 47.  Prevent unauthorised access to authorised areas  Implement appropriate access control  Implement intruder alarm system  Accompany all Visitors in authorized areas 3/29/2015 47 Drug Regulations - Online Resource for latest information.
  48. 48.  Premises and storage facilities should be clean and free from litter and dust.  Cleaning programmes, instructions and records should be in place  Appropriate cleaning equipment and cleaning agents should be chosen and used  They should not be a source of contamination. 3/29/2015 48 Drug Regulations - Online Resource for latest information.
  49. 49.  Design premises to prevent entry of insects, rodents or other animals.  Equip the premises to prevent entry of insects, rodents or other animals.  Implement a preventive pest control programme 3/29/2015 49 Drug Regulations - Online Resource for latest information.
  50. 50.  Segregate rest, wash and refreshment rooms from the storage areas.  Prohibit food, drink, smoking, medicinal products for personal use in the storage areas. 3/29/2015 50 Drug Regulations - Online Resource for latest information.
  51. 51.  Install suitable equipment to check the environment  Implement procedures to check the environment  Environmental factors to be considered include ◦ Temperature ◦ Light ◦ Humidity ◦ Cleanliness of the premises. 3/29/2015 51 Drug Regulations - Online Resource for latest information.
  52. 52.  Perform an initial temperature mapping exercise under representative conditions  Place temperature monitoring probes based on initial results  Position probes in the areas that experience the extremes of fluctuations 3/29/2015 52 Drug Regulations - Online Resource for latest information.
  53. 53.  Repeat the mapping exercise ◦ Based on the results of a risk assessment exercise ◦ Whenever significant modifications are made to the facility ◦ Whenever significant modifications are made to the temperature controlling equipment  For small premises ◦ (of a few square meters which are at room temperature )  Perform a risk assessment  Place temperature monitors accordingly. 3/29/2015 53 Drug Regulations - Online Resource for latest information.
  54. 54.  Design, Locate and Maintain equipment impacting storage and Distribution to a standard intended for its purpose.  Implement Planned maintenance for key equipment vital to the functionality of the operation  Calibrate equipment used to control or to monitor the environment at defined intervals based on a risk and reliability assessment. 3/29/2015 54 Drug Regulations - Online Resource for latest information.
  55. 55.  Calibration should be traceable to a national or international measurement standard.  Install & set alarms for excursions from predefined storage conditions  Test alarms regularly to ensure adequate functionality  Perform equipment repair, maintenance and calibration so that the integrity of products is not compromised. 3/29/2015 55 Drug Regulations - Online Resource for latest information.
  56. 56.  Make and Maintain records of key equipment for ◦ Repairs ◦ Maintenance ◦ Calibration 3/29/2015 56 Drug Regulations - Online Resource for latest information.
  57. 57.  Key equipment ◦ Cold stores ◦ Monitored intruder alarm ◦ Access control systems, ◦ Refrigerators, ◦ Thermo hygrometers, or ◦ Other temperature and humidity recording devices, ◦ Air handling units and ◦ Any equipment used in conjunction with the onward supply chain. 3/29/2015 57 Drug Regulations - Online Resource for latest information.
  58. 58.  System should be capable of achieving the desired results accurately, consistently and reproducibly  Perform appropriate Validation or Verification before use 3/29/2015 58 Drug Regulations - Online Resource for latest information.
  59. 59.  Prepare a written, detailed description of the system ◦ including diagrams where appropriate  Keep this up to date  Describe ◦ Principles, ◦ Objectives, ◦ Security measures, ◦ System scope and ◦ Main features, ◦ How the computerised system is used and ◦ The way it interacts with other systems. 3/29/2015 59 Drug Regulations - Online Resource for latest information.
  60. 60.  Only authorized persons should enter or amend data.  Secure data by physical or electronic means  Check stored data periodically for accessibility  Protect data by backing up at regular intervals.  Retain Backup data for at least 5 years ◦ Follow national legislation  Store this at a separate and secure location. 3/29/2015 60 Drug Regulations - Online Resource for latest information.
  61. 61.  Define procedures for system failure or breaks down.  This should include systems for the restoration of data. 3/29/2015 61 Drug Regulations - Online Resource for latest information.
  62. 62.  Ensure correct installation and operation  Identify requirement for key equipment qualifications  Identify requirement for key process validation  Use Risk assessment to define the scope and extent of such qualification and/or validation activities 3/29/2015 62 Drug Regulations - Online Resource for latest information.
  63. 63.  Qualify and/or validate  Before commencing use and  After any significant changes ◦ e.g. repair or maintenance 3/29/2015 63 Drug Regulations - Online Resource for latest information.
  64. 64.  Prepare validation and qualification reports ◦ Summarise the results obtained ◦ Comment on any observed deviations  Document deviations  Implement CAPA to prevent recurrence  Satisfactory validation and acceptance of a process or piece of equipment should be produced and approved by appropriate personnel. 3/29/2015 64 Drug Regulations - Online Resource for latest information.
  65. 65.  Good documentation is essential part of quality system.  Written documentation should ◦ Prevent errors from spoken communication. ◦ Permit the tracking of relevant operations during the distribution of medicinal products. 3/29/2015 65 Drug Regulations - Online Resource for latest information.
  66. 66.  Documentation comprises all written ◦ Procedures ◦ Instructions ◦ Contracts ◦ Records and data, in paper or in electronic form.  Documentation should be readily available/retrievable. 3/29/2015 66 Drug Regulations - Online Resource for latest information.
  67. 67.  Follow Directive 95/46/EC ◦ With regard to the  Processing of personal data of employees,  Complainants or  Any other natural person 3/29/2015 67 Drug Regulations - Online Resource for latest information.
  68. 68.  Sufficiently comprehensive  Cover all distributor’s activities  Language understood by personnel  Clear  Unambiguous language  Free from errors 3/29/2015 68 Drug Regulations - Online Resource for latest information.
  69. 69.  Procedures should be ◦ Approved ◦ Signed ◦ Dated by the responsible person.  Documentation should be ◦ Approved, ◦ Signed and dated by appropriate authorised persons ◦ Not be handwritten ◦ Sufficient space should be provided for handwritten entries 3/29/2015 69 Drug Regulations - Online Resource for latest information.
  70. 70.  Any alteration should be signed and dated;  Alteration should permit the reading of the original information.  Where appropriate, the reason for the alteration should be recorded. 3/29/2015 70 Drug Regulations - Online Resource for latest information.
  71. 71.  Retain documents for at least 5 years ◦ Follow national legislation  Delete or anonymise personal data when not required  Documents should be easily accessible to employees. 3/29/2015 71 Drug Regulations - Online Resource for latest information.
  72. 72.  Use only valid and approved procedures.  Documents should have unambiguous content; title, nature and purpose should be clearly stated.  Review Document regularly and kept up to date.  Apply version control  Prevent inadvertent use of the superseded documents  Remove & archive superseded or obsolete procedures 3/29/2015 72 Drug Regulations - Online Resource for latest information.
  73. 73.  Keep records of any transaction in medicinal products received, supplied or brokered ◦ Purchase/sales invoices ◦ Delivery slips ◦ On computer ◦ Any other form 3/29/2015 73 Drug Regulations - Online Resource for latest information.
  74. 74.  Minimum information required: ◦ Date ◦ Name of the medicinal product ◦ Quantity received, supplied or brokered ◦ Name and address of the  Supplier ,Customer Broker or Consignee, as appropriate ◦ Batch number  At least for medicinal product bearing the safety features ◦ Records should be made at the time each operation is undertaken. 3/29/2015 74 Drug Regulations - Online Resource for latest information.
  75. 75.  All actions should ensure that ◦ The identity of the medicinal product is not lost ◦ The wholesale distribution is performed according to the information on the outer packaging. ◦ Risk of falsified medicinal products entering the legal supply chain is minimized 3/29/2015 75 Drug Regulations - Online Resource for latest information.
  76. 76.  All medicinal products distributed in the EU by a wholesale distributor must be covered by a marketing authorisation granted by the EU or by a Member State 3/29/2015 76 Drug Regulations - Online Resource for latest information.
  77. 77.  Distributor, other than marketing authorisation holder, must notify the marketing authorisation holder and the competent authority of their intention to import that product.  All key operations described should be fully described in the quality system in appropriate documentation. 3/29/2015 77 Drug Regulations- Online Resource for Latest Information
  78. 78.  Supplies should be from ◦ Persons in possession of a wholesale distribution authorisation, or ◦ Persons in possession of a manufacturing authorisation which covers the product in question 3/29/2015 78 Drug Regulations- Online Resource for Latest Information
  79. 79.  Distributors receiving products for the purpose of placing these products on the EU market, must hold a manufacturing authorisation 3/29/2015 79 Drug Regulations- Online Resource for Latest Information
  80. 80.  Where products are obtained from another distributor the receiving distributor must verify that the ◦ Supplier complies with the principles and guidelines of good distribution practices and ◦ That they hold an authorisation for example by using the Union database.  If the medicinal product is obtained through brokering, the distributor must verify that the broker is registered and complies with the requirements specified for them. 3/29/2015 80 Drug Regulations- Online Resource for Latest Information
  81. 81.  Approve and Qualify suppliers prior to any procurement of medicinal products.  Have a procedure for this approval and qualification.  Document the results  Review periodically 3/29/2015 81 Drug Regulations- Online Resource for Latest Information
  82. 82.  Carry out ‘due diligence’ for new suppliers to assess the ◦ Suitability, ◦ Competence and ◦ Reliability  Attention should be paid to: ◦ The reputation or reliability of the supplier; ◦ Offers of medicinal products more likely to be falsified; ◦ Large offers of medicinal products which are generally only available in limited quantities; and ◦ Out-of-range prices. 3/29/2015 82 Drug Regulations- Online Resource for Latest Information
  83. 83.  Supply medicinal products only to persons ◦ Who are in possession of a distribution authorisation ◦ Who are authorised ◦ Who are entitled to supply Medicinal products to the public. 3/29/2015 83 Drug Regulations- Online Resource for Latest Information
  84. 84.  Perform Checks and periodic rechecks by ◦ 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. 3/29/2015 84 Drug Regulations- Online Resource for Latest Information
  85. 85.  Monitor transactions and investigate any irregularity in ◦ Sales patterns of narcotics, psychotropic substances or other dangerous substances. ◦ Unusual sales patterns that may constitute diversion or misuse of medicinal product  Report to competent authorities where necessary  Take steps to ensure fulfilment of any public service obligation 3/29/2015 85 Drug Regulations- Online Resource for Latest Information
  86. 86.  Receiving function should ensure that the ◦ Arriving consignment is correct, ◦ Medicinal products originate from approved suppliers and ◦ Products have not been visibly damaged during transport. 3/29/2015 86 Drug Regulations- Online Resource for Latest Information
  87. 87.  Prioritise products requiring special storage or security measures  Transfer to appropriate storage once checks have been conducted 3/29/2015 87 Drug Regulations- Online Resource for Latest Information
  88. 88.  Transfer Batches to saleable stock only after confirmation that they are authorised for sale  Put in place written procedures for this operation  Check control report as per Article 51(1) of Directive 2001/83/EC or  Another proof of release based on an equivalent system 3/29/2015 88 Drug Regulations- Online Resource for Latest Information
  89. 89.  Store Medicinal products separately from other products  Protect from the harmful effects of ◦ light ◦ temperature ◦ moisture and ◦ other external factors  Particular attention should be paid to products requiring specific storage conditions. 3/29/2015 89 Drug Regulations- Online Resource for Latest Information
  90. 90.  Clean incoming containers of medicinal products  Maintain appropriate storage conditions  Allow for appropriate security of stocks  Rotate stock: first expiry, first out (FEFO) principle  Document exceptions 3/29/2015 90 Drug Regulations- Online Resource for Latest Information
  91. 91.  Prevent spillage, breakage, contamination and mix-ups.  Do not store products directly on the floor ◦ Exceptions like some medicinal gas cylinders  Withdraw products nearing or are beyond expiry date from saleable stock  Have segregation either physically or through electronic means  Perform regular stock inventories ◦ Consider national legislation  Stock irregularities should be investigated and documented. 3/29/2015 91 Drug Regulations- Online Resource for Latest Information
  92. 92.  Identify products for destruction  Store separately and  Have a written procedure  Handle as per procedure  Follow national or international requirements for ◦ Handling, ◦ Transport and ◦ Disposal of such products  Maintain records of all destroyed products 3/29/2015 92 Drug Regulations- Online Resource for Latest Information
  93. 93.  Have controls in place to pick correct product  Product should have an appropriate remaining shelf life when it is picked. 3/29/2015 93 Drug Regulations- Online Resource for Latest Information
  94. 94.  Have a delivery note for each supply  Details in Delivery Note ◦ date; ◦ name and ◦ pharmaceutical form of the medicinal product, ◦ batch number at least for products bearing the safety features; ◦ quantity supplied; ◦ name and address of the supplier, ◦ name and delivery address of the custome and ◦ applicable transport and storage conditions.  Records should be kept so that the actual location of the product can be known. 3/29/2015 94
  95. 95.  The export of medicinal products falls within the definition of ‘wholesale distribution’  A person exporting medicinal products must hold a wholesale distribution authorisation or a manufacturing authorisation.  This is also the case if the exporting wholesale distributor is operating from a free zone. 3/29/2015 95 Drug Regulations- Online Resource for Latest Information
  96. 96.  All rules for wholesale distribution apply  However, products do not need a MA of EU  Take measures to prevent these products reaching the EU  Supply products to persons who are authorised to receive medicinal products for wholesale distribution or  Supply to the public in accordance with the applicable legal and administrative provisions of the country concerned. 3/29/2015 96 Drug Regulations- Online Resource for Latest Information
  97. 97.  Handle as per written procedures  Make records available to the competent authorities.  Assess returned products before approval for resale.  Consistent approach by all partners in supply chain to fight against falsified medicinal products 3/29/2015 97 Drug Regulations- Online Resource for Latest Information
  98. 98.  Record complaints with all the original details.  Distinguish between Quality & Distribution related complaints  Inform the manufacturer and/or marketing authorisation holder about Quality Related Complaints  Investigate distribution related complaint to identify the origin of or reason for the complaint  Appoint a person to handle complaints  Allocate sufficient support personnel 3/29/2015 98 Drug Regulations- Online Resource for Latest Information
  99. 99.  Implement follow-up actions  Implement CAPA  Notify the national competent authorities 3/29/2015 99 Drug Regulations- Online Resource for Latest Information
  100. 100.  Handle returned products according to a written procedure. Process should be based on ◦ Risk Assessment ◦ Product concerned ◦ Any specific storage requirements ◦ The time elapsed since the medicinal product was originally dispatched.  Follow National Law  Follow contractual arrangements between the parties 3/29/2015 10 0 Drug Regulations- Online Resource for Latest Information
  101. 101.  Products should only be returned to saleable stock if all of the following are confirmed: ◦ Products are in their unopened and undamaged secondary packaging ◦ Are in good condition ◦ Have not expired ◦ Have not been recalled 3/29/2015 101 Drug Regulations- Online Resource for Latest Information
  102. 102.  Products should only be returned to saleable stock if all of the following are confirmed: ◦ Products returned from a customer not holding a distribution authorisation or from pharmacies should always be returned to saleable stock if they are returned within an acceptable time limit, for example 10 days. 3/29/2015 102 Drug Regulations- Online Resource for Latest Information
  103. 103.  Products should only be returned to saleable stock if all of the following are confirmed: ◦ It has been demonstrated by the customer that the medicinal products have been transported, stored and handled in compliance with their specific storage requirements; ◦ They have been examined and assessed by a sufficiently trained and competent person authorised to do so; 3/29/2015 103 Drug Regulations- Online Resource for Latest Information
  104. 104.  Products should only be returned to saleable stock if all of the following are confirmed: ◦ The distributor has reasonable evidence that the product was supplied to that customer (via copies of the original delivery note or by referencing invoice numbers, etc.) and the batch number for products bearing the safety features is known, and that there is no reason to believe that the product has been falsified. 3/29/2015 104 Drug Regulations- Online Resource for Latest Information
  105. 105.  For products requiring specific temperature storage conditions returns to saleable stock can only be made if there is documented evidence that the product has been stored under the authorised storage conditions throughout the entire time. 3/29/2015 105 Drug Regulations- Online Resource for Latest Information
  106. 106.  For storage condition deviations perform a risk assessment. The evidence should cover: ◦ Delivery to customer; ◦ Examination of the product; ◦ Opening of the transport packaging; ◦ Return of the product to the packaging; ◦ Collection and return to the distributor; ◦ Return to the distribution site refrigerator. 3/29/2015 106 Drug Regulations- Online Resource for Latest Information
  107. 107.  Products returned to saleable stock follow ‘first expired first out’ (FEFO)  Stolen products that have been recovered cannot be returned to saleable stock and sold to customers. 3/29/2015 107 Drug Regulations- Online Resource for Latest Information
  108. 108.  Inform the competent authority and the marketing authorisation holder of any suspision  Have a written procedure in place to this effect  Record with all the original details  Conduct an investigation  Physically segregate falsified medicinal products  Store in a dedicated area away from all other medicinal products.  All relevant activities in relation to such products should be documented and records retained. 3/29/2015 108 Drug Regulations- Online Resource for Latest Information
  109. 109.  Evaluate the effectiveness of recall process at least annually  Process should be capable of prompt implementation  Follow the instructions of a recall message  Some recall instructions may require approval by competent authorities 3/29/2015 109 Drug Regulations- Online Resource for Latest Information
  110. 110.  Record the operation at the time it is carried out  Make records available to the competent authorities.  Make distribution records accessible for recall  Records should contain sufficient information ◦ Distributors and ◦ directly supplied customers (with addresses, phone and/or fax numbers inside and outside working hours 3/29/2015 110 Drug Regulations- Online Resource for Latest Information
  111. 111.  Records should contain sufficient information ◦ Batch numbers at least for Medicinal products bearing safety features ◦ Exported products ◦ Medicinal product samples  The progress of the recall process should be recorded for a final report 3/29/2015 111 Drug Regulations- Online Resource for Latest Information
  112. 112.  Outsourced activity should be ◦ Correctly defined, ◦ Agreed and ◦ Controlled in order to prevent product integrity issues  Written Contract between the Contract Giver and the Contract Acceptor  Clearly establish the duties of each party 3/29/2015 112 Drug Regulations- Online Resource for Latest Information
  113. 113.  The Contract Giver is responsible for ◦ Activities contracted out. ◦ Assessing the competence of the Contract Acceptor ◦ Ensuring by means of the contract and through audits that the principles and guidelines of GDP are followed.  Preform and audit of the Contract Acceptor ◦ Before awarding an contract ◦ When there are changes to activities  Audit frequency should be based on risk depending on the nature of the outsourced activities  Audits should be permitted at any time 3/29/2015 113 Drug Regulations- Online Resource for Latest Information
  114. 114.  The Contract Giver should provide the Contract Acceptor with all the information necessary to carry out the contracted operations in accordance with the specific product requirements and any other relevant requirements. 3/29/2015 114 Drug Regulations- Online Resource for Latest Information
  115. 115.  Contract Acceptor should have ◦ Adequate premises ◦ Equipment ◦ Procedures ◦ Knowledge ◦ Experience ◦ Competent personnel  to carry out the work ordered by the Contract Giver. 3/29/2015 115 Drug Regulations- Online Resource for Latest Information
  116. 116.  Do not pass contracted work to a third party without the prior evaluation and approval by the Contract Giver  For such arrangements wholesale distribution information should be available  Refrain from any activity which may adversely affect the quality of the products  Forward information that can influence the quality of the products to the Contract Giver 3/29/2015 116 Drug Regulations- Online Resource for Latest Information
  117. 117.  Conduct self-inspections to  Monitor implementation of GDP  Compliance with GDP principles and  Propose necessary corrective measures 3/29/2015 117 Drug Regulations- Online Resource for Latest Information
  118. 118.  Cover following in self Inspections ◦ All aspects of GDP ◦ Compliance with the regulations, guidelines and procedures within a defined time frame.  Self- inspections may be divided into several individual self- inspections of limited scope. 3/29/2015 118 Drug Regulations- Online Resource for Latest Information
  119. 119.  Self-inspections should be ◦ Impartial ◦ Detailed ◦ Conducted by designated competent company personnel.  Independent external audits are useful ◦ This may not be used as a substitute for self-inspection. 3/29/2015 119 Drug Regulations- Online Resource for Latest Information
  120. 120.  Record all self-inspections  Reports should contain all the observations .  Provide a copy to the management and other relevant persons.  Determine the cause of deficiencies  Implement corrective and preventive actions (CAPA)  Document the actions and follow it up 3/29/2015 120 Drug Regulations- Online Resource for Latest Information
  121. 121.  Responsibility of the supplying wholesale distributor ◦ To protect medicinal products against breakage, adulteration and theft; ◦ To ensure that temperature conditions are maintained within acceptable limits during transport. 3/29/2015 121 Drug Regulations- Online Resource for Latest Information
  122. 122.  Demonstrate that the medicines have not been exposed to conditions that may compromise their quality and integrity.  Adopt a risk-based approach when planning transportation. 3/29/2015 122 Drug Regulations- Online Resource for Latest Information
  123. 123.  Maintain required storage conditions during transportation.  Report any deviation or damage during transportation,  Report this to the distributor and recipient of the affected medicinal products.  Have a procedure for investigating and handling temperature excursions. 3/29/2015 123 Drug Regulations- Online Resource for Latest Information
  124. 124.  Ensure that vehicles and equipment used  Are suitable for their use to ◦ Distribute, ◦ Store ◦ Handle medicinal products  Are equipped to prevent exposure of the products to conditions that could affect their quality and packaging integrity. 3/29/2015 124 Drug Regulations- Online Resource for Latest Information
  125. 125.  Have written procedures for ◦ The operation and maintenance of all vehicles ◦ Equipment involved in the distribution process ◦ Cleaning and safety precautions  Use risk assessment of delivery routes to determine where temperature controls are required.  Calibrate and maintain equipment used for temperature monitoring at least once a year. 3/29/2015 125 Drug Regulations- Online Resource for Latest Information
  126. 126.  Use dedicated vehicles and equipment for handling medicinal products.  Have procedures to ensure that the quality will not be compromised when non- dedicated vehicles and equipment are used.  Make deliveries to the address stated on the delivery note only.  Medicinal products should not be left on alternative premises. 3/29/2015 126 Drug Regulations- Online Resource for Latest Information
  127. 127.  For emergency deliveries ◦ Have designated persons ◦ Have written procedures  For third party transportation have a contract meeting requirements specified under “ Out sourced activities”.  Make transporter aware of the relevant transport conditions. 3/29/2015 127 Drug Regulations- Online Resource for Latest Information
  128. 128.  Pay attention to temperature monitoring, cleanliness and the security of any intermediate storage facilities in case of unloading , reloading and transit storage.  Minimise the duration of temporary storage while awaiting the next stage of the transportation route. 3/29/2015 128 Drug Regulations- Online Resource for Latest Information
  129. 129.  Transport products in containers that have ◦ No adverse effect on the quality of the products. ◦ That offer adequate protection from external influences, including contamination. 3/29/2015 129 Drug Regulations- Online Resource for Latest Information
  130. 130.  Base selection on ◦ The storage and transportation requirements; ◦ The space required for the amount of medicines; ◦ The anticipated external temperature extremes; ◦ The estimated maximum time for transportation including transit storage at customs; ◦ The qualification status of the packaging and the validation status of the shipping containers. 3/29/2015 130 Drug Regulations- Online Resource for Latest Information
  131. 131.  Container labels should provide sufficient information on ◦ Handling and storage requirements and ◦ Precautions to ensure that the products are properly handled and secured at all times.  The containers should enable identification of the contents of the containers and the source. 3/29/2015 131 Drug Regulations- Online Resource for Latest Information
  132. 132.  Maintain a safe and secure supply chain for ◦ Narcotics or psychotropic substances ◦ Follow National requirements  Have additional controls in place for delivery of these products.  Have a protocol to address the occurrence of any theft. 3/29/2015 132 Drug Regulations- Online Resource for Latest Information
  133. 133.  Transport highly active and radioactive materials in safe, dedicated and secure containers and vehicles.  The relevant safety measures should be in accordance with international agreements and national legislation. 3/29/2015 133 Drug Regulations- Online Resource for Latest Information
  134. 134.  Use qualified equipment for temperature- sensitive products to ensure correct transport conditions. ◦ Thermal packaging, ◦ Temperature-controlled containers or ◦ Temperature controlled vehicles 3/29/2015 134 Drug Regulations- Online Resource for Latest Information
  135. 135.  Calibrate and maintain the temperature monitoring equipment  Perform temperature mapping under representative conditions  Consider seasonal variations  Provide information to demonstrate that products have complied with the temperature storage conditions to customers 3/29/2015 135 Drug Regulations- Online Resource for Latest Information
  136. 136.  Cool packs in insulated boxes should not come in direct contact with product  Train staff for ◦ Assembly of the insulated boxes (seasonal configurations) ◦ Reuse of cool packs. 3/29/2015 136 Drug Regulations- Online Resource for Latest Information
  137. 137.  Have a system to control the reuse of cool packs  Ensure that incompletely cooled packs are not used in error  There should be adequate physical segregation between frozen and chilled ice packs  Have written procedure for delivery of sensitive products and control of seasonal temperature variations. 3/29/2015 137 Drug Regulations- Online Resource for Latest Information
  138. 138.  A ‘broker’ is a person involved in activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person. 3/29/2015 138 Drug Regulations- Online Resource for Latest Information
  139. 139.  Brokers are subject to a registration requirement.  They must have a permanent address and contact details in the Member State where they are registered.  They must notify the competent authority of any changes to those details without unnecessary delay. 3/29/2015 139 Drug Regulations- Online Resource for Latest Information
  140. 140.  By definition, brokers do not procure, supply or hold medicines.  Therefore, requirements for premises, installations and equipment as set out in Directive 2001/83/EC do not apply.  However, all other rules in Directive 2001/83/EC that apply to wholesale distributors also apply to brokers. 3/29/2015 140 Drug Regulations- Online Resource for Latest Information
  141. 141.  Define the quality system of a broker  Document the Quality System, approve and keep it up to date.  It should set out ◦ Responsibilities ◦ Processes and ◦ Risk management in relation to their activities 3/29/2015 141 Drug Regulations- Online Resource for Latest Information
  142. 142.  Have an emergency plan for recalls  Inform competent authorities immediately of any suspected falsified medicines offered in the supply chain. 3/29/2015 142 Drug Regulations- Online Resource for Latest Information
  143. 143.  Train personnel ◦ In the applicable EU Legislation ◦ National legislation ◦ In the issues concerning falsified medicinal products 3/29/2015 143 Drug Regulations- Online Resource for Latest Information
  144. 144.  The general provisions on documentation chapter apply.  In addition following procedures and reports should be available ◦ Procedure for complaints handling; ◦ Procedure for informing competent authorities and marketing authorisation holders of suspected falsified medicinal products; ◦ Procedure for supporting recalls; ◦ Procedure for ensuring that medicinal products brokered have a marketing authorisation; 3/29/2015 144 Drug Regulations- Online Resource for Latest Information
  145. 145.  In addition following procedures and reports should be available ◦ Procedure for verifying  That their supplying wholesale distributors hold a distribution authorisation,  Their supplying manufacturers or importers hold a manufacturing authorisation and  Their customers are authorised to supply medicinal products in the Member State concerned; 3/29/2015 145 Drug Regulations- Online Resource for Latest Information
  146. 146.  Keep records either in the form of ◦ Purchase/sales invoices ◦ On computer ◦ In any other form  Records should contain the following information: ◦ Date; name of the medicinal product; ◦ Quantity brokered; name ◦ Address of the supplier and the customer; ◦ Batch number at least for products bearing the safety features. 3/29/2015 146 Drug Regulations- Online Resource for Latest Information
  147. 147.  Make records available  To the competent authorities  For inspection purposes  For the period stated in national legislation but at least 5 years. 3/29/2015 147 Drug Regulations- Online Resource for Latest Information
  148. 148. This presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional. Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals. 3/29/2015 14 8

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