The Pharmaceutical Industry falls under the process industry domain, and also includes Biotechnology, Medical Devices and Nutriceuticals (Health Supplements). Regulatory compliance is one of the significant industry drivers. The primary goal of the industry is to get products speedily to market that are manufactured under consistent processes, to the correct formula and specifications, in the correct environment, with the appropriate controls applied, delivered to the correct customers.
The challenges they potentially face are to:
- Monitor and report on safety and health regulation compliance.
- Ensure quality and traceability of raw materials and manufactured products.
- Manage product life cycles.
- Improve time-to-market and streamline business processes.
- Improve electronic collaboration with customers and external partners.
- Reduce costs of production and distribution.
- Innovate - develop new products to remain profitable and competitive.
- Manage seasonal demand.
- Ensure quality and traceability of work in progress from subcontract manufacturers.
- Ensure efficient warehouse management
- Manage product and raw material shelf life.
- Manage customer relationships.
- Reduce risk of and manage product recalls.
- Plan and manage distribution and goods in transit.
- Manage complex and highly variable pricing and discount structures in international markets.
- Protect intellectual property.
- Control product recipe changes.
- Accommodate and manage dynamic production plans.
- Ensure a high degree of formula precision.
- Constantly monitor and analyze product and customer activity.
- Integrate shop floor control and quality systems with business systems.
- Plan and manage capacity.
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