Introduction:
Distribution is an essential activity in the integrated supply-chain management of pharmaceutical products. Various individuals and entities are generally responsible for the handling, storage, and distribution of such products.
So it's very important to have adequate controls over the entire chain of distribution' To maintain the original quality of Pharmaceutical products, every party involved in the distribution chain has to comply with the applicable requirement' Each activity in the distribution of pharmaceutical products shall be caned out according to the principles of Good Distribution Practice (GDP)' The nature of the risks involved is likely to be similar to that for risk countered in the manufacturing environment, e.g. mix-ups, adulteration, contamination' cross-contamination' spurious besides inherent potential for degradation of such products if not maintained and distributed under specied storage conditions. Good Distribution Practice (GDP) is much more than just the distribution of products. The MHRA (the UK authority) dened GDP as "the sum of all of the processes and activities designed and implemented to ensure that the quality of medicines is maintained throughout the distribution chain from manufacturer to patient, ensuring compliance with regulatory requirements at all relevant stages. It includes the storage and transportation of APls, other ingredients and packaging components used in the production of the medicines.
" The World Health Organization denes GDP as "that part of quality assurance that ensures that the quality of pharmaceutical product, is maintained by means of adequate control of the numerous activities which occur during the distribution process as well as providing a tool to secure the distribution system from counterfeits, unapproved, illegally imported, stolen counterfeit sub-standard, adulterated, and/or misbranded pharmaceutical products”. The critical need to establish controls at all points the supply chain is an increasing challenge for all pharmaceutical companies and their partners in handling and transporting medicines globally.
The global growth of counterfeiting, not only of nished products but also of APIs, is a major issue for the industry. The implementation of GDP is essential for keeping counterfeits out of the legitimate supply chain/distribution network chain vulnerable to counterfeits.
Hence, good distribution practice remains an essential aspect of compliance for all pharmaceutical products as raw material and products are transported and delivered on a global and local basis.
Need of GDP and Regulatory Concerns
In the pharmaceutical industry, good distribution is not just a case of guaranteeing that a patient’s supply of medicine made available on time when needed It is a case of ensuring that the entire supply chain and distribution network is focused on supplying a quality product that complies at every point with regulatory requirements and is t for its purpose, when it reaches the patient. Failure to comply, within the pharmaceutical supply chain can seriously compromise the quality of the product and hence patient safety.
In this context, the supply chain extends well beyond the vehicles used to take bulk pharmaceutical (such as APIs) and medical components to the manufacturing facility and nished products from the manufacturing facility to distributors/wholesalers.
It also must ensure compliant delivery to hospitals, pharmacies and even super markets where patients receive their medicines
We (as manufacturing pharmacist/chemist as patients) would like to know that the excellent quality under which medicines are made in the manufacturing facility also extends all along the legitimate supply chain to ensure that self and our families are always safe.
The supply chain is becoming more complex and global, raising serious practical questions about where the supply chain starts and ends, and precisely where control must be focused to guarantee quality all the way from ingredients to the nal medicine. The more global and complex the distribution network, the more dicult it is to ensure that goods follow approved routes, are transported by approved and trained delivery drivers, and that records are properly maintained and quality is assured at every point along the pharmaceutical supply chain.
Counterfeit Pharmaceutical Products are a real threat to public health and safety:
Consequently, it is essential to protect the pharmaceutical supply chain against the penetration of such products. Weak points in the distribution processes of pharmaceutical products provide an avenue for counterfeit as well as illegally imported, stolen and substandard medicines to enter the supply chain.This is a concern in both developed and developing countries.
The methods by which such products enter the supply chain have become increasingly complex and have resulted in the development of thriving secondary and grey markets throughout the world. The involvement of unauthorized entities in the distribution and sale of pharmaceutical products is a particular concern. Only a joint approach including all parties involved in the supply chain can be successful in the ght against counterfeit pharmaceutical products and, therefore, all parties active in the market should take an active part in collaborative activities.
Scope of GDP
The storage, sale and distribution of pharmaceutical products are often carried out by various companies, institutions and individuals.
GDP explores different aspects of the distribution process within the supply chain and to avoid the introduction of counterfeits into the market place via the distribution chain. The nature of the risks involved in distribution is likely to be similar to that for risks encountered in the manufacturing environment, e.g. mix-ups, adulteration, contamination and cross contamination.
When the distribution chain is interrupted by manufacturing steps, such as repackaging and re-labeling, the principles of good manufacturing practices (GMP) should be applied to these processes.
Regulatory Overview:
Worldwide, there are a number of international Regulatory Guidelines, which toss light over the requirement, and importance of GDP. These are more or less aligned, but some have specics e.g. Argentina, Brazil, Saudi Arabia etc.
Few highlights are as below:
0n March 1,2013, the European Commission nalized and published the Good Distribution Practice (GDP) guideline which replaces the GDP Guideline published in 1994 (941C 63/03) and will apply to not only to the wholesalers and manufacturers of pharmaceuticals, but it also incorporates the specic requirements for brokers dearing with pharmaceutical products. Its requirements (Ref: 2O13lC 6g/0.1) will enter into force on 8 September 2013.
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; Sucient 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 falsied medicinal products and recalls; Outsourced activities correctly dened 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).
World Health organization has released WHO technical Report Series, No. 957, 20.1 0, Annex 5 – WHO good distribution practices for pharmaceutical products.
This document lays down guidelines for the distribution of pharmaceutical products. Depending on the national and regional legislation on pharmaceuticals, these guidelines may apply equally for human and for veterinary use. WHO has also released, model requirements for the storage and transport of time and temperature sensitive Pharmaceutical Products TRS No. 961, Annexure 9 (2011).
The National Regulatory Body Government Pharmaceuticals and Medical Devices in India, Central Drugs Standard Control Organization (CDSCO) has released the Guidelines on Good Distribution Practices for Biological Products.
CDSO also released the Guidelines on Good Distribution Practices for Pharmaceutical Products. This draft CDSO Regulations covers a broad range of issues and activities are intrinsic to a validated supply chain:
Appropriate organization and management of suppliers
Personnel and training
Quality systems and self-inspection in keeping with ISO or other accepted national or international guidelines
Warehousing and storage
Temperature control of both products and the storage environment Inventory control
Transportation
Dispatch and receipt of goods
Documentation and record-keeping
Complaint mechanisms
Recalls and returns
Counterfeit pharmaceutical products Importation
Contractual obligations.
GDP is applicable to all persons and outlets involved in any aspect of the storage and distribution of pharmaceutical products from the premises of the manufacturer of the product to the person dispensing or providing pharmaceutical products directly to a patient or his or her agent. This includes all parties involved in trade and distribution of pharmaceuticals, including the manufacturers of bulk, finished products, wholesalers as well as others such as suppliers, distributors, government institutions, international procurement organization, donor agencies, and certifying bodies, logistics providers, traders, transport companies and forwarding agents and their employees as well as health workers.
It also includes ensuring the quality and identity of pharmaceutical products during all aspects process. These aspects include, but are not limited to, procurement, purchasing, storage, distribution, transportation, repackaging, re-labeling, documentation and record-keeping practices
Source: The Pharma Review
