Case Studies

Galentic Pharma is a pharmaceutical manufacturing company that manufactures a range of ophthalmic products and non-sterile dermatological products ( cream, ointments, lotion, application, emulsions, gel and several others). The state-of-the-art manufacturing facility of Galentic is situated close to Mumbai, the commercial capital of India & Kandla (Gujarat), in proximity to ports. They have two manufacturing plants, at Rabale(Maharashtra) and Kandla(Gujarat).

Galentic Pharma needed their manufacturing processes to be quality compliant and be able to follow inspection related regulations. Inventory management, production planning and sub-contracting processes were not integrated in their system.

We had detailed requirement gathering sessions with the core team members of Galentic Pharma to understand their business processes. Multiple sessions were conducted with each department to understand the intricacies/details of their working process and, being a pharma company, the norms that are being followed. On-site visits were conducted by us, where we went through an entire live Purchase/Production process. The process was captured, and a business blueprint was finalized by Galentic.

Our “Add-Ons” to SAP B1 for ‘Quality Check’ and ‘Route Card’ was developed in order to meet the requirements for Galentic Pharma for the following Manufacturing & Quality Inspection requirements:

• Manufacturing process steps definition and inspections for each “in-process” steps
• Resources for accounting items, labor, machine hours and cost
• Production scheduling based on optimum use of machines.
• Quality Inspections for each Batch/Lot/Serial Number/Sampling/Container, for incoming raw materials, intermediates, and finished Products.
• Batch Transfer from one item number to another item number with quality inspection and sampling
• Label printing and certificate of analysis reports
• Additionally, the ‘Subcontracting’ Add-On was implemented in order to capture their vendor subcontracting processes.

Six months

The Add-Ons developed are in full accordance with all the Pharmaceutical standard processes and are developed keeping in mind the stringent SOPs that need to be followed in by a pharmaceutical company.