Companies that produce pharmaceuticals, cosmetics and other highly regulated products face a specific set of requirements when it comes to ERP selection.
These processors must meet stringent mandates by the FDA and international agencies, thus they seek ERP systems that help manage compliance with regulations such as the FDA requirements outlined in 21 CFR Part 11.
We’re currently working with a process manufacturer in the pharmaceutical industry, and well understand the importance of evaluating ERP systems that offer the highest standards of efficiency, traceability and quality.
Quality, Formula Management Features
When considering ERP for the pharmaceutical industry, the focus is on quality control, adherence to regulatory authority controls and improved visibility and traceability.
A critically important consideration when evaluating ERP systems is that the processor gains extensive quality management features including the ability to initiate and track a well-documented Non-conformance Report and Corrective Action Preventive Action processes.
Tightly integrated Formula Management is also a critical need. This includes accurately managed version control for key documents (e.g. CoA’s – Certificates of Authenticity; Recipes and Formulations), as well as the ability to automatically generate and manage Safety Data Sheets (formerly MSDS) based on formulas created by the manufacturer.
Other Formula Management features should include the ability to adjust formulas on the fly to account for concentration variations, as well as the ability to specify a lot for a customer based on the customer’s specifications. These specifications may differ from customer to customer, so the ERP system must offer the flexibility to track at this level.
Industry-Specific ERP Features for Pharmaceutical Producers
For pharmaceutical companies, compliance with the FDA requirements outlined in 21 CFR Part 11 and validation of this compliance is a critical aspect of any implementation. The ERP system must provide the required set of documents as part of the validation process.
ERP systems should offer additional industry capabilities including:
- Lot control for full forwards and backwards traceability, down to the container level
- FEFO (First Expiration, First Out) inventory management
- Tracking of extensive quality testing with a fully integrated LIMS (Laboratory Information Management System)
- Multi-part formulation (pre-blend added to a main blend)
- Global Harmonized Codes international classification for chemicals
We’ve only touched on selected aspects of what’s needed in terms of ERP.
Pharmaceutical producers are wise to seek ERP selection expertise from those with a clear understanding of the issues faced by the sector.
Industry-specific knowledge is critical for manufacturers to implement best practices, tools and technology proven to help pharmaceutical processors fully comply with strict mandates.
For further insight, please contact the Ultra team.