GOOD DISTRIBUTION PRACTICES FOR PHARMACEUTICAL PRODUCTS

The Indian pharmaceutical market remains attractive and is expected to grow to US$ 55 billion by 2020 according to the McKinsey & Company report titled " India Pharma 2020: Propelling access and acceptance realizing true potential". Although India is one of the most significant emerging markets, there are challenges around product quality and regulatory complexity.

 Distribution is an essential activity in the integrated supply-chain management of pharmaceutical products

Importance of good distribution practice:

Good distribution practices ensure maintaining product safety and quality during distribution across the supply chain and this practice is of significant importance for the pharmaceutical industry. ...

The challenges of the pharmaceutical products supply chain is and due to its specified shelf life and storage conditions.

 GDP compliance:

Good Distribution Practice (GDP) is that part of quality assurance which ensures products are consistently stored, transported and handled under suitable conditions as required by the marketing authorization (MA) or product specification.

WHO guidelines on good storage practices pharmaceuticals:

Storage areas should be designed or adapted to ensure appropriate and good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Pharmaceutical products should be stored off the floor and suitably spaced to permit cleaning and inspection.

General principles of storage of pharmaceutical products:

Proper environmental control (i.e., proper temperature, light, and humidity, conditions of sanitation, ventilation, and segregation) must be maintained wherever drugs and supplies are stored in the premises.

GDP warehouse:

Good Distribution Practices (GDP) is a quality system for warehouse and distribution centers dedicated for medicines. Internationally accepted pharmaceutical GDP regulations stipulate that distributors of pharmaceutical products must align their operations with the standards

At present transportation of drugs are carried out by third parties like contractors and sub-contractors in most cases. Contamination, cross contamination, mix-ups, adulteration and presence of spurious drugs are an issue in the unregulated distribution chain. Involvement of unauthorized entities in the distribution chain is also a concern.

The pharmaceutical distribution system in India is undergoing a paradigm shift and we will continue to see improvements, through compliance with the latest standards and the implementation of the latest technologies for supply chain management.

Good distribution practices ensure maintaining product safety and quality during distribution across the supply chain and this practice is of significant importance for the pharmaceutical industry. Good Distribution Practices (GDP) Compliance report for Pharmaceutical Industry demonstrates Quality commitment & sound practices in the entire pharmaceutical distribution supply chain.

The various dosage forms (eg tablets, syrups, injectables etc.) are to be transported and stored at different environmental conditions hence all medicines cannot be handled with a general rule. viz the requirement of handling tablets, syrups and injectable shall widely vary.

Cold chain product range of medicines are stored at temperature between 2 to 8 o C. For cold chain products, therefore the degree of carefulness shall be more due to the fear of product failures during quality control testing by customers. The GDP guidelines are intended to be 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.

The GOOD DISTRIBUTION PRACTICE guidelines ……Are intended to be 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.

OBJECTIVE

The objective of these guidelines is to ensure the quality and identity of pharmaceutical products during all aspects of the distribution process. These aspects include, but are not limited to procurement, purchasing, storage, distribution, transportation, documentation and record-keeping practices

SCOPE

This includes all parties involved in trade and distribution of pharmaceutical, 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

GENERAL PRINCIPLES -- According to Drugs & Cosmetics Act 1940 and Drugs & Cosmetic Rules 1945, Rules 64 and 65 specify the conditions to be fulfilled to sell, stock, exhibit or offer for sale or distribute the drugs. An agreement shall be in place with all the individual agencies involved in the storage, transportation and distribution regarding…

·        REGULATION OF THE DISTRIBUTION OF PHARMA PRODUCTS

·        ORGANIZATION AND MANAGEMENT, PERSONNEL.

·        QUALITY SYSTEM

·        PREMISES, WAREHOUSING AND STORAGE

·        TEMPERATURE, ENVIRONMENT AND STOCK CONTROL.

·        TRANSPORTATION, SHIPMENT CONTAINERS AND LABELING

·        DISPATCH AND RECEIPT.

·         DOCUMENTATION, COMPLAINTS & CONTRACT ACTIVITIES

·        RECALLS AND RETURNS, SELF-INSPECTION

·        SPURIOUS PHARMACEUTICAL PRODUCTS & IMPORTATION

CONCLUSION

# The guidelines will mandate a documented quality policy, detailing intentions & requirements of distributors regarding quality, authorized by the management and regulation of storage premises like warehouses.

# Various jobs in the distribution chain will be detailed and will require an organizational chain.  Procedures for procurement and release shall be in place for documentation so that the products are traceable in the supply chain and help in monitoring product recall.

Courtesy: Secondary Research & newsletter