Virtutis Pharmaceuticals complies with Good Distribution Practices in every aspect of its services.
We distribute in an integral activity integrated in our supply-chain management of pharmaceutical products as per our standard quality system for pharmaceutical warehouse and distribution centers. Governed by the Singapore HSA regulations we ensure that the distribution aligns to our operations with the perfect standards. Our scheme ensures compliance of the entire supply chain, right from the delivery of raw materials to the manufacturing plants, to the final shipment of drugs to the end users.
Through our GDP system we not only focus on guaranteeing that our product are made available to patients in time, we also focus on the supply of a quality product that adheres to all standards of any regulatory environment. Our main objective of GDP compliance is to ensure the identity and quality of our products during the distribution cycle. The process includes procurement, purchasing, storage, distribution, transportation, packaging, relabeling, documentation and record-keeping practices.
We follow cGDP guidelines as applicable to all the entities and outlets involved in any aspects of the distribution process. This includes trade and distribution of the pharmaceutical products, manufactures of bulk, finished products, wholesalers, government institutions, donor agencies, certifying bodies, Etc. As per WHO guidelines every entity in the distribution process has to comply with the regulations and standards of the GDP, to achieve the original quality of the pharmaceutical products.
OUR PRINCIPLES OF GDP
The parties involved in the distribution process must ensure that the quality and the integrity of the distribution are maintained throughout the distribution chain.
To follow the principles of GDP that are included in the national legislation; the guidelines for distribution must be included as per the region for establishing basic standards of distribution.
The principles of GDP followed by the every contractor who moves forward the pharmaceutical product till the entity responsible for dispensing the product or till the product is provided to the patient.
Issues such as traceability and recognition of security risks must also apply due diligence with adherence to the GDP principles.
All the active parties involved in the distribution chain must be in collaboration to avoid the exposure of counterfeit products to the patients.
REGULATIONS THAT WE FOLLOW
- National legislation regulates the activities of the entities or individuals involved in the distribution of pharmaceutical products.
- The organization to which the distributor belongs to should be an entity that is authorized in terms of applicable legislation for performing the intended functions, and the organization must take the accountability for the activities that it performs.
- Only authorized or licensed persons or entities are designated for importing and exporting pharmaceutical products.
- Distributors can distribute a pharmaceutical product within the country or territory with a granted marketing authorization.
- Authorized distributors must obtain the supplies of pharmaceutical products only from the entities that are authorized to sell or supply.
- Authorized persons or entities can be delegated with certain duties. These duties should be specified in a written agreement without any gaps or overlaps with regard to the GDP application. The delegated activities should be documented.
- The distributor cannot subcontract the activities to another entity unless the entity is authorized as of the same standards of the distributor.
- Only the registered and authorized mail-ordered pharmacies can use internet as a medium to sale the pharmaceutical products.
VEHICLES AND EQUIPMENT
Vehicles and equipment used to distribute the pharmaceutical products are checked for their suitability and appropriateness, to prevent the exposure of the products to the contamination of any kind. Technologically advanced global positioning system, electronic tracking device that helps in enhance the security of the distributed pharmaceutical product. Procedures must ensure the integrity of the products during the transportation. Defective vehicles must be labeled so or removed from the practice. It should be ensured that all the vehicles are free from dust and dirt, and required measures should be in place to prevent unauthorized persons form tampering the vehicles.
SHIPMENT CONTAINERS AND LABELLING
Each shipment container is checked for quality deficiency to prevent damage of products. The containers are labelled to provide required information on storage conditions and labeling. The labeling should help in identification of the contents in the container.
If any potentially toxic and hazardous products are being shipped then care must be taken, if a pharmaceutical product is supposed to be transferred to areas outside the scope, then the name, and address of the manufacturer, safety labels, and any essentialities must be included on the container label.
PRODUCTS IN TRANSIST
When the products are in transportation we ensure that :
- Product identity should not be lost
- Product does not contaminate by other contaminated product
- Products are safe from breakage, spillage and theft
ADVANTAGES OF OUR GDP SYSTEM :
- It helps maintain the product quality and patient safety
- Reduces the risk of drug counterfeiting
- It helps in increasing the market share
- It improves the customer satisfaction
- It helps in reducing the distribution complaints
“Good distribution practices” is an integrated part of our quality assurance that ensures the perfection in the quality of a pharmaceutical product. It is maintained through numerous activities that occur during the distribution cycle.