The “e Manufacturing Execution System” for pharmaceutical manufacturing is different from eMES in any other manufacturing industry. The difference primarily comes from the stringent Regulatory Compliance norms to be adhered to in Pharmaceutical Operations. In the Pharmaceutical Manufacturing the eMES is also referred as eBMR or “e Batch Manufacturing Record”.
The key objectives of implementing “e Manufacturing Execution Systems” (or eBMR) in Pharma Manufacturing are:
Achieve Compliance with global regulatory norms, quality processes and ALCOA + norms.
Achieve Data integrity across functions, systems and equipment records.
Audit readiness: Become ever ready for audit, with complete electronic records.
Paperless operation: Achieve paperless (or less paper) operation at the plant.
Pharmaceutical companies operate in one of the most dynamic and highly regulated environments. Regulatory audit frequencies have increased. Warning letters & import restrictions incidences have increased alongside. Many companies fail in clearing Regulatory Audits. Failing an audit results in over two years of business loss and huge expenses in achieving success with re-audit.
Most of the Pharmaceutical Manufacturing organizations have realized that they must implement a comprehensive eMES/eBMR systems for achieving the stated objective for long term business survival in todays regulated environment. However, the existing infrastructure scenario, inhibit moving forward with such implementation.
The scenario: Many Pharmaceutical Manufacturing Units are supplying to strongly regulated markets. They have a mix of the following infrastructure scenario:
Obsolete Equipment: Some equipment are obsolete in their design. These have no digital ability to record and communicate critical operations parameters for recording into BMR.
Semi-modern equipment: Some equipment have some digital ability to show records but are not enabled for automatic data transmission to SCADA database.
Modern Equipment: Some equipment are modern, PLC controlled and they can store digital data for some time. They still need to be integrated to SCADA (Supervisory Control And Data Acquisition) system. There are also several cases of failures in implementing eMES solution provided by global brands providing the MES solution. Some of the key reasons of eMES implementation project failures are:
Design and Architecture of MES Solutions: A generic MES, modified for Pharma, would not succeed in Pharma. The eMES must be designed for Pharmaceutical operations, where the regulatory compliance requires flexibility in system to allow special process steps, for which there is no global best practices. The system must be architected for allowing new recipe, new product and new process to be quickly configured.
Right collaboration: Very often IT Team of Pharma companies would be good at handling the ERP Software and Level 3 & Level 4 IT systems. They would lack expertise of Level 1 and Level 2 Automation. Companies need to get right IT Solution providers capable of supplying and implementation right eMES along with Automation Solutions.
Comprehensive Solution: A comprehensive solution design would encompass eMES, integration with ERP, integration with SCADA and direct integration with many devices. The SCADA and Automation solution would include upgrading the semi modern equipment, connecting them along with modern equipment to SCADA. Adopting right strategy solution for obsolete equipment.
Phased implementation Strategy: There is variety of strategies for eMES implementation with complete automation integration. Designing and selecting right strategy is a Critical Success Factor.
The country, the facility location, equipment vendors, employees, organization culture, the product and market combination etc., makes every unit and unique unit. The eMES solution must be designed to suit each such unit. One solution would not fit all. The solutions must be configurable for taking care of the uniqueness. The solutions must be robust and maintainable.
Laurel MES™ product suite for “e Manufacturing Execution” is architected and designed for Pharmaceutical Manufacturing businesses to achieve compliance and audit readiness. Laurel MES™ comes along with Automation Solution and Systems Integration Solution which provides a complete, comprehensive and configurable solution. The drug product variants, market variants and product changeover challenges are addressed as required. Management dashboards and scorecards are fascinating. This solution is integration-ready for latest manufacturing and testing equipment.
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