Introduction
When running a pharma business, manufacturing is not the only deliverable. It requires a systematic approach to source, manufacture, store, ship and distribute it in the hands of their end users, and it is done under the umbrella of supply chain management. It is the responsibility of supply chain management to coordinate with all stakeholders and align their deliverables with the business strategies & targets.
Supply chain management in the pharma industry ensures the product’s efficacy, quality and fulfills patient’s requirements at the right place and right time. For this to happen, pharma manufacturers must invest in modern and pharma-centric supply chain practices and quality & safety.
Despite recognition by the pharma industry and the allocation of dedicated resources, the supply chain in the pharma industry is full of challenges. The critical nature of pharma products and regulatory requirements make it challenging to implement effective supply chain management policies for the benefit of both manufacturers and patients.
Pharma Supply Chain management and its importance
Pharma supply chain management is the coordinated activities of all entities from start to the finish, i.e. from R&D to final finished transportation, in a timely, effective and accurate manner. It enhances collaboration between different stages of the product life cycle and helps to fulfil business requirements for a pharma manufacturer.
Supply chain management for pharma is critical for several reasons.
● Timely delivery of raw materials for manufacturing and finished drugs to end users by using process visibility at each stage.
● Effectively managing supply chain disruptions using stand - by techniques, such as alternative sources, multiple routes and production planning.
● Maintaining high quality and safety standards for the product at each stage by deploying quality enhancement resources, such as environment control and product monitoring
● Reducing the cost of the final finished product by implementing cost-effective measures, such as controlling wastage and utilizing latest manufacturing technologies
Challenges to pharma supply chain management
Let’s discuss some challenges faced by pharma supply chain management.
Lack of Visibility
The product quality and efficacy depend on the raw material being sourced for each step, and pharma manufacturers must ensure the quality of the items being sourced. Although pharma manufacturers test and verify the material specification upon material delivery, they often find it difficult to verify supplier-side practices, such as
● What are the transportation conditions, specifically if the raw material is temperature-sensitive
● Their source of raw materials, manufacturing compatibility and compliance requirements
● Manufacturing resources and conditions.
These visibility issues make the product manufacturer vulnerable to supply chain disruptions, quality compromise and lack of real-time data, which ultimately is reflected in product quality, efficiency and productivity.
Regulatory Compliance
Regulatory compliance is an important aspect of the pharma industry and must be implemented for every business operation. Regulatory compliance is also required for supply chain management to allow them to sell and market drug products in their area of jurisdiction.
Regulatory compliance for the supply chain becomes more critical because raw materials are often sourced from different regions of jurisdiction that have varying requirements and regulations. Pharma drug manufacturers must comply with each regional market regulations from which they procure raw materials.
The varying compliance requirements force the drug manufacturer to keep up to date with the relevant regulatory regulations, such as documentation and procedures. It enables them to continuously supply of raw materials, prevent fines, material confiscation and restrictions.
Counterfeit products
Pharma products are often the target of counterfeiting, especially in region...
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