1. Want Top Performing EBR’s. Think Outside the Document
Want Top Performing EBR’s? Think Outside the Document! Robert Pochadt
The staff at InstantGMP prepared the GMP for Dietary Supplements Compliance Series of presentations to focus on good manufacturing practices and GMP compliance for dietary supplements manufacturing. These are brought to you by our quality and manufacturing experts in the hope that it will help you avoid any GMP compliance issues in your shop. This presentation will address the flow of GMP processes.

2. An EBR can be more than a requirement met
Must have formulation, in process tests, instructions, deviation management, etc. per the FDA guidelines
Can additionally become a manufacturing business tool
Configurability allows a wide variety of data capture options to support production AND operations analysis
Checks for resources
Inventory (sufficient quantities to produce?)
Production equipment (Available? If not, is an alternative available?)
Production facilities (Areas cleaned to eliminate contamination?)
Instructions ( Latest SOP’s visible?)
Automated capture (PLC’s, equipment readings connected by IoT)

3. Why EBR needs more than a document
Documents are formats for authoring; instruction content is needed in an EBR but not sufficient by itself
Resource availability easier managed by checking real-time status through integration
The EBR formatting and execution is much more efficient without the need to repeatedly check out, revise, and check in for all EBR input

4. Retrofits do not cut the EBR mustard in GMP
LIMS…….your product is not a sample
CRM……..needs a process modeling backend
EDMS…….limited by the document format
ERP……..needs detail in execution, genuine GMP workflows, and frequently, third party validation
WMS….as CRM, but needs traceability

5. Benefits of well-tuned EBR’s
Reduced cycle time and improved uptime
Increased throughput, less WIP
Improved capacity utilization for the most capital intensive resources
Reduced defects
Data for process improvement analytics, e.g., yield vs. temperature
Configurability to adapt to changes in business models or industries; one system for all lines of production
Improved life cycle for production equipment
A power tool format for continuous process improvements