Supply chain management is the successful management and planning of all supply chain activities that take place in a business. This can include logistics, sourcing and product development. Its aim to gain competitive advantages and customer satisfaction with better use of assets and resources.
The coordination of daily information about transfer of goods among various members of supply chain and the movement and transfer of goods from one place to another place are the core responsibilities of a pharmaceutical supply chain professional.
The supply and management of pharmaceutical materials is a continuous process. To maintain the smooth and quality supply of pharmaceutical materials below mentioned steps can be followed:
- Selection of materials
- Quantification of materials
- Procurement
- Storage/distribution
- Use
- Monitoring and improving material management cycle
- Quality assurance in material management cycle
In each of the above-mentioned steps of the cycle, quality assurance measures should be included. Where the following issues should be addressed:
- Selection of well documented quality products from reliable manufacturers.
- Certificate of Analysis of delivered products.
- Use of the WHO certification scheme.
- Quality assessment of drugs upon receipt.
- Inspection of shipments.
- Laboratory testing.
- Appropriate storage and transport.
- Appropriate dispensing and use.
- Monitoring of product quality/ reporting system.
For pharmaceutical products with proper drug registrations and marketing approvals, the procurement agency concentrates mainly on the commercial aspects of procurement. However, it must ensure that such products have complied with quality standards.
In which countries that have no drug registration system, quality assurance measures must be built into the procurement process to ensure safety, efficacy and quality of pharmaceutical products. In addition, a system for monitoring and maintaining product quality throughout the product’s shelf life is important.
FDA safeguards the integrity of the drug supply chain through initiatives that help protect consumers from exposure to substandard drugs and ensure that safe and effective drugs reach U.S. consumers. These initiatives include:
- Be Safe Rx
- Know Your Source: Protecting Patients from Unsafe Drugs
- Letters to doctors who may have purchased counterfeit or unapproved prescription drugs
Product or service suppliers should be reviewed at intervals consistent with the significance of the product or service provided to demonstrate the conformance to specified requirements.
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