Distribution is an important activity in the integrated supply chain management of pharmaceutical products. Here we have gathered some guidelines to make good distribution practices.
The importance of good distribution practices
Good distribution practices are essential for maintaining product safety and quality throughout the supply chain. This practice is crucially important to the pharmaceutical industry.
The supply chain for pharmaceutical warehousing products is challenging due to the shelf life and storage conditions.
GDP compliance
Good Distribution Practice (GDP), is a part of quality control that ensures that products are stored, transported, and handled in the right conditions according to the product specification or marketing authorization (MA).
WHO Guidelines on Good Storage Practices for Pharmaceuticals
It is important to design or adapt storage areas in order to provide good storage conditions. They should be kept clean, dry, and within acceptable temperatures limits. Pharmaceutic products should not be placed on the floor.
The general principles of the storage of pharmaceutical products
Proper environmental control must be observed wherever drugs or supplies are kept in the premises.
GDP Warehouse
Good Distribution Practices (GDP), is a system that ensures the quality of warehouses and distribution centers for medicines. Internationally accepted pharmaceutical GDP regulations require that pharmaceutical distributors align their operations with these standards.
Currently, drug transportation is carried out by contractors or sub-contractors. The unregulated distribution chain is prone to contamination, cross contamination, mixed-ups, adulteration, and the presence of illicit drugs. Unauthorized entities are also a concern in the distribution chain.
Good distribution practices are essential for maintaining product safety and quality throughout the supply chain. Good Distribution Practices Compliance Report for Pharmaceutical Industry. This report demonstrates quality commitment and sound practices throughout the entire distribution chain.
There are many dosage forms, including syrups, tablets, and injectables. medications must be stored and transported in different environments so that they can be used safely. The requirements for handling syrups, tablets, and injectables will vary widely.
Cold chain medicines range from 2-8 C. This is due to the possibility of product failures during quality assurance testing by customers. These guidelines will apply to all people and outlets involved in the storage and distribution pharmaceutical products, from the manufacturing site to the person providing or dispensing pharmaceutical products to patients or their agents.
Guidelines
These GOOD DISTRIBUTION PACT guidelines will apply to all people and outlets involved in any aspect regarding the storage and distribution pharmaceutical products, from the premises where the product was manufactured to the point at which it is delivered to the patient or agent.
OBJECTIVE
These guidelines are intended to guarantee the identity and quality of pharmaceutical products in all aspects of distribution. These include but are not limited: procurement, purchasing, storage and distribution, transport, documentation, record-keeping, and documentation.
SCOPE
All parties involved in the distribution and trade of pharmaceuticals include manufacturers of bulk and finished products as well as distributors.
GENERAL PRINCIPLE
All agencies involved in storage, transportation, and distribution of information regarding… shall enter into an agreement.
* REGULATION ABOUT THE DISTRIBUTION PHARMA PRODUCTS
* ORGANIZATION & MANAGEMENT, PERSONNEL
* QUALITY SYSTEM
* PREMISES, WARENHOUSES AND STORAGE
* TEMPERATURE AND ENVIRONMENT, AND STOCK CONTROL.
* TRANSPORTATION, SHIPMENT CONTAINERS, AND LABELING
* DISPATCH & RECEIPT
* DOCUMENTATION, COMPLAINTS, & CONTRACT ACTIVITIES
* RECALLS and RETURNS, SELF INSPECTION
* SPURIOUS PHARMACEUTICAL PRODUCTS & IMPORTATION
CONCLUSION
These guidelines will require a documented quality policy that details the intentions and requirements of distributors in regards to quality. They are authorized by regulation of storage facilities like warehouses, and management.
The distribution chain will have many jobs and each job will require an organizational structure. For documentation purposes, procedures for procurement and release must be established. This will ensure that products can be traced through the supply chain and allow for product recall monitoring.