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Good Distribution Practices

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Good Distribution Practices

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This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation

This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation

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Good Distribution Practices

  1. 1. 1 INTRODUCTION TO GDPAND LEGAL REQUIREMENTS PUT WORLDWIDE Presented by: Vanshika Gupta 1st sem M.Pharm(RA) GRP (MRA101T) PARUL INSTITUTE OF PHARMACY
  2. 2. CONTENT • Introduction • Objective • Scope • General Principles • Advantage Of GDP • Specific GDP Requirement For USFDA • Specific GDP Requirement For EMA 2
  3. 3. INTRODUCTION • Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain • Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products. • Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable. • The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious. 3
  4. 4. OBJECTIVE • These guideline main goal is to protect pharmaceutical products' identity and quality through each step of the distribution chain. • Procurement, purchasing, storage, distribution, transportation, documentation, and record-keeping procedures are only a few of these elements. 4
  5. 5. SCOPE • These guidelines are intended to apply to all individuals and organizations involved in any aspect of the storage and distribution of pharmaceutical products, from the location of the product's manufacturer to the individual dispensing or providing pharmaceutical products directly to a patient or his or her representative. • GDP also applies to the sourcing, storage and transportation of active pharmaceutical ingredients and other ingredients used in the production of the medicines. 5
  6. 6. Cont.. • All parties involved in the trade and distribution of pharmaceuticals are covered by this, including producers of bulk and finished goods, wholesalers, suppliers, distributors, government organizations, international procurement organizations, donor agencies, certifying bodies, logistics service providers, traders, transport firms, and forwarding agents, as well as their staff members and healthcare professionals. • The guidelines issued by various regulatory bodies across the globe are similar in their fundamental approach. They outline the practices to be followed in the key areas of distribution, processes, infrastructure, and workforce. 6
  7. 7. Cont.. • Regulatory bodies across the globe which are having similar in their fundamental approach. • These areas are highlighted below: • Personnel • Quality System • Premises Warehousing and Storage • Documentation • Traceability • Complaints and Returns • Transportation 7
  8. 8. General Principles 1. According to GDP standards, national legislation must ensure that the pharmaceutical product distribution process is under strict control. (A subject covered earlier in this article.) 2. The distributor should be a legitimate, registered business, as they will be in charge of ensuring that the pharmaceuticals or medical devices are delivered safely. 3. To import or export pharmaceutical products, one must only be authorized or work for a company that has the proper authorization. 4. Distributors can only carry out a distribution of a pharmaceutical product in nations where it is legal to do so. 5. Only third parties with the necessary licenses may be delegated duties and responsibilities. 8
  9. 9. Cont.. 6. Distributors can only provide their services to businesses that are authorized to produce or interact with pharmaceutical products. 7. Pharmaceutical products should only be supplied by distributors or their agents to individuals or organizations who are legally permitted to purchase them. 8. The subcontractor must have the required authorization to use the person or organization. 9. Only registered and approved mail-order pharmacies or other authorized companies should be able to sell medicinal products online. 9
  10. 10. Personnel • Designate people responsible for GDP compliance. • Personnel should be competent, experienced, trained, and qualified. • Training and maintenance of training records based on documented SOPs • Adopt appropriate procedures related to personnel hygiene, health, and clothing • Establish an organizational structure with distinct roles and connections between them. • Put a code of conduct and punishments in place to deal with issues with contamination or falsification. 10
  11. 11. Quality System • Document a Quality Policy with defined procedures and that are periodically reviewed. • Appoint designated personnel to ensure a quality system with specified authority. • Authorize procurement and release procedures. • Inspect, audit, and attain a certificate of compliance with ISO quality standards. • Periodically evaluate your risks. 11
  12. 12. Premises and Warehouse • Ensure good storage practices • Enforce precautions and policies to prevent unauthorized access • Dedicate storage area for hazardous, quarantine and counterfeit (rejected) products • Follow First Expiry, First Out (FEFO) during distribution • Ensure adequate lighting and HVAC system (heating, ventilation and air conditioning systems) 12
  13. 13. Documentation • Maintain appropriate documentation with written/ electronic records of all activities • Ensure that documents are completed, approved and signed by the authorized personnel • Prepare documents that are sufficiently comprehensive, with clear and specific language • Keep records for the definite amounts of time specified by national law. 13
  14. 14. Traceability • Prepare procedures and documents to ensure traceability of products distributed, to facilitate recalls • Identify and map all stakeholders involved in the supply chain, depending on the type of product and national policies and legislation • Develop internationally compatible product coding and identification system in collaboration with involved parties 14
  15. 15. Complaints and Returns • Systematically record and review complaints. • Make early communication to concerned entity in case of counterfeit (rejected) or substandard product. • Investigate and identify the reason of complaints thoroughly. • Prepare written procedures for handling and acceptance of returned products. • Ensure physical segregation and storage of returned stock from saleable stock. 15
  16. 16. Transportation • To ensure the quality – Vehicles must be dry and free from insects, rodents, etc. to prevent pilferage, contamination, or adulteration – Where special storage conditions (e.g., temperature and relative humidity) need to be maintained, these should be provided, checked, monitored, and recorded – The individuals responsible should be informed about all relevant conditions for storage and transportation 16
  17. 17. Cont.. • To ensure product safety – Technology such as Global Positioning System (GPS) enabled electronic tracking devices, and engine-kill buttons to vehicles should be used – Dedicated vehicles must be used for transportation – In case of the use of third-party carriers, distributors should maintain a written contract as per the national legislation 17
  18. 18. Self- Inspections • The distributor should conduct and record self-inspections in order to monitor the implementation of and compliance with these guidelines. • Regular self-inspections should be performed in accordance with an approved schedule 18
  19. 19. Distribution chain of Pharmaceutical Products 19
  20. 20. Advantages of GDP • Drugs are constantly transported in the proper conditions with good distribution practises. • Reduces distribution complaints • Reduces expensive mistakes • Helps achieve consistency • Reduces wastage • With the good distribution practices, the pharmaceutical industry may grow Sustainably and Effectively. • The right product gets delivered to the right person at the right time by following good distribution practices. 20
  21. 21. Specific GDP requirement for USFDA • Vehicles and equipment: - The design and use of vehicles and equipment must aim to minimize the risk of errors and permit effective cleaning and/or maintenance to avoid contamination. - There should be procedures in place for the operation and maintenance of all vehicles and equipment involved in the distribution process, including cleaning and safety precautions. - Should be kept clean and dry and free from accumulated waste. - Should be kept free from rodents, vermin, birds and other pests. - A written cleaning programme should be available, indicating the frequency of cleaning and the methods to be used. 21
  22. 22. Cont.. • Repackaging and relabeling: - Should only be performed by distributors appropriately authorized and/or licensed to do so, and in accordance with GMP principles - Where these functions are performed they should comply with the applicable national, regional and international guidelines relating to repackaging and relabeling of pharmaceutical products. • Counterfeit pharmaceutical products: - Any suspected counterfeit drug found in the pharmaceutical supply chain should be segregated immediately from other pharmaceutical products and recorded. 22
  23. 23. Cont.. - Such products should be clearly labelled to prevent further distribution or sale. - Should be informed immediately to the holder of the marketing authorization • Importation: - A nation's ports of entry for the processing of pharmaceutical product imports should be restricted by suitable laws. - Pharmaceutical products should be stored under suitable conditions for as short a time as possible. 23
  24. 24. Specific GDP requirement for EMA • Contract activities: - Any activity relating to the distribution of a pharmaceutical product which is delegated to another person or entity should be performed according to the terms of a written contract which is agreed upon by the contract giver and the contract accepter • Operations: The wholesale distribution of medicinal products is performed according to the information on the outer packaging. The wholesale distributor should use all means available to minimise the risk of falsified medicinal products entering the legal supply chain. • 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. 24
  25. 25. Cont.. • Specific Provisions for Brokers: - 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. 25
  26. 26. REFERENCES 1. Hadjihamza F, Pandova E, Bozinova V. Good Distribution Practice for medicinal products. Your hosts Macedonian Pharmaceutical Association and Faculty of Pharmacy, Ss Cyril and Methodius University in Skopje.:447. 2. WHO good manufacturing practices for pharmaceutical products: main principles. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations: forty- eighth report. Geneva: World Health Organization; 2014: Annex 2 (WHO Technical Report Series, No. 986; https://www.who.int/medicines/areas/quality_safety/quality _assurance/TRS986annex2.pdf accessed 5 December 2019). 26
  27. 27. Cont.. 3. Kumar N, Jha A. Pharmaceutical Good Distribution Practices–A Review of Global Scenario. International Journal of Pharma Sciences and Research. Retrieved from http://www. ijpsr. info/docs/IJPSR15-06-12-013. pdf. 2015 Dec. 4. WHO guide to good storage practices for pharmaceuticals. In: WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Thirty-seventh report. Geneva, World Health Organization, 2003, Annex 9 (WHO Technical Report Series, No. 908) 5. https://www.linkedin.com/pulse/principles-good-distribution- practices-michaela-shalby 27
  28. 28. Cont.. 6. https://eur-lex.europa.eu/legal- content/EN/TXT/HTML/?uri=CELEX:52013XC1123(01)&f rom=EN 7. https://www.bsigroup.com/en-IN/gdp-certification-for- pharmaceutical- industry/#:~:text=Good%20Distribution%20Practices%20(G DP)%20is,their%20operations%20with%20the%20standards. 8. https://www.pharmananda.com/blog/detail/what-is-gdp- good-distribution-practice 9. https://www.mondaq.com/india/healthcare/1031480/good- distribution-practices-for-pharmaceutical-products 10. https://www.nexdigm.com/data/resource/OPPI-Good- Distribution-Practices-for-pharmaceutical-products.pdf 28
  29. 29. 29 THANK YOU

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