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

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. CONTENT
• Introduction
• Objective
• Scope
• General Principles
• Advantage Of GDP
• Specific GDP Requirement For USFDA
• Specific GDP Requirement For EMA
2

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. 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. 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. 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. 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. 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. 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. 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.
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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. 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)
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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. 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. 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. 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. 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. 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. Distribution chain of Pharmaceutical
Products
19

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. 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. 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. 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. 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. 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.
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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. 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
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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
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