P51 - Liquid Dosage Forms

In principal, the scenario for Liquid Dosage Forms (cough free syrup TuSAPin) comprises the same processes as the scenario for Solid Dosage Forms. The main differences are that the active ingredient is purchased externally and the last two steps of the production process (filling and packaging) are performed by an external subcontractor.

Process Flow

The following processes are provided to support the Liquid Dosage Forms scenario:

• Flexible planning / Material requirements planning
• Procurement of batch materials / Procurement of non batch materials
• Manufacturing of Liquid Dosage Forms (cough free syrup)
• Filling and Packaging (External Subcontracting)
• Sales of drugs / Sales of OTC products
• Vendor handling / Customer handling

The following functionalities and processes were implemented respecting also special GMP requirements.

Key Points

• Integrated sales and production rough planning
• Cost center planning and product costing
• Automatic batch determination according to expiration date
• Automatic batch number generation
• Process order execution
• Generation of PI sheets
• Digital signature in PI sheet
• Post process control with early inspection lot creation (on process order release)
• Batch where used list
• Batch determination according to FIFO

In addition, the browser-based PI-Sheet contains not only useful information on the manufacturing process (such as dangerous goods symbols, notes on occupational health and safety, material data), but also a Process Manufacturing Cockpit. The PMC shows how to implement

• Company logos for personalization
• General documentation
• Internet links
• Video clips in order to present complex processes
• Access to standard transactions

The Process Manufacturing Cockpit can also be used for sending alert messages.