Our Pharmacy Manufacturing System is a software application thatensuresincreasing yourUnit’s overall productivity with tools to simplify workflow, accuracy, improved time to market, quality control, regulatory compliance, securityand thus enabling you to deliver properly through a more efficient, automated process.

Details

Pharmaceutical manufacturers must contend with the conflicting requirements for complying with regulations from many agencies – with the need to maintain security, particularly during the development and testing phases. Top 3 issues facing pharmaceutical manufacturers are inventory management (for both ingredients and products), production management/quality assurance, and regulatory compliance. Ingredients and products are often controlled substances and must be secured. In addition, both types of substances can have a limited shelf life. Not only must the shipping be documented, but disposal must be secure, documented, and non-polluting. Even manufacturing start-up is regulated for some compounds.

Researchers and Analysts at iFahja understand that our pharmaceutical manufacturing software should support the FDA’s process analytical technology (PAT) initiative and be capable of addressing these 3 problems. This is why our offered System promises in the delivery of a complete and well integrated solution that will help in increasing the efficiency, productivity and security of you manufacturing unit(s), result in cost reduction and peace of mind.

Available Features/Functions/Modules

Our system offers the following features:

  • Formulation management and batch sizing
  • Available to promise, Capable to promise
  • For Lot Tracing and Recall, this module enables the identification and tracking by tying ingredients of each batch to their individual batch number. Similarly identification of all of the affected batches and the customers that received those batches
  • Appropriate labeling of standard and homeopathic products  i.e., in compliance to existing regulations
  • Drug Enforcement Agency (DEA) and Environmental Protection Agency compliance, if your unit uses ‘Controlled Substances’  and ‘Toxic Substances’ respectively, as ingredients
  • Support for quality assurance (QA) testing (problem identification/reporting and identifying critical process parameter and defining their affect on critical quality attributes
  • Yield variances. Tracking actual yield versus expected yield for each batch. Reporting excessive variance based on user-defined thresholds and indicating  if variances are so large that regulating agencies should be notified
  • Packing & drumming
  • Inventory management, storage, planning. Finished goods management. Sales/orders/Stock management
  • Expiration tracking
  • Shipping.