Pharmaceuticals

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. Government authorities have to ensure public safety, focusing on quality and safety checks in receiving, manufacturing, storing, packaging, dispatching and delivering. Extensive record keeping of procedures, processes and systems is also a requirement of this industry. Tracking of components and the finished product, even after the sale, has become a necessity. 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.

Common characteristics of the pharmaceuticals industry

Pharmaceutical manufacturers share many common characteristics:

  • Raw material and finished goods tracking.
  • Quality monitoring.
  • Large sales volumes.
  • Process manufacturing - batch.
  • Process manufacturing - continuous.
  • Manufacturing methods - synthesis, extraction and biotechnology.
  • Wide variety of customer types.
  • Some seasonality.
  • Forecasting.
  • Material Requirements Planning.
  • Subcontract manufacture.
  • Research and development intensive.
  • Capital intensive.
  • JIT and Lean Manufacturing.
  • Product licensing and patenting.
  • Large sales force.
  • Patent disputes and litigation.
  • Partnering with other companies.
  • Specialisation.
  • Extensive animal and clinical trials.
  • By-products and co-products.
  • Stringent records management requirements.
  • Make to stock.
  • Make to order.
  • Package to order.
  • Complex formulas.
  • Service extensive global markets.

Pharmaceuticals industry challenges

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 the storage and retrieval of compliance documentation and certification.
  • Manage product life cycles.
  • Service complex markets.
  • Improve time-to-market and streamline business processes.
  • Comply with Sarbanes-Oxley and local accounting regulations.
  • Improve electronic collaboration with customers and external partners in the supply chain, while ensuring data security.
  • Reduce costs of production and distribution.
  • Innovate - develop new products to remain profitable and competitive.
  • Manage seasonal demand.
  • Manage product promotions and complex pricing.
  • Account for royalties and licensing fees.
  • Ensure quality and traceability of work in progress from subcontract manufacturers.
  • Ensure efficient warehouse management and order picking and packing operations.
  • 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.
  • Minimise cost of development cycle.
  • Maximise material yields.
  • Manage different units of measure for all levels of the product recipes.
  • Control product recipe changes.
  • Accommodate and manage dynamic production plans.
  • Ensure a high degree of formula precision.
  • Constantly monitor and analyse product and customer activity.
  • Integrate shop floor control and quality systems with business systems.
  • Plan and manage capacity.

SYSPRO product modules can address these challenges

SYSPRO addresses these challenges with the following modules from its extensive enterprise resource planning suite. Suggested modules include:

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