Design Specification ‐ MBR (Recipe and Process Instruction) - lucasgsantos/BIM GitHub Wiki

Manufacturing Execution System (MES) Design Specification

Focused on MBR, Recipe Design, Process Instructions, and Electronic Batch Record Execution

1. Introduction

This document outlines the design specification for a Manufacturing Execution System (MES). The focus areas include:

  • Master Batch Record (MBR) Design
  • Recipe & Workflow Design
  • Process Instructions & Operator Guidance
  • Execution of Electronic Batch Records (EBR)

2. Master Batch Record (MBR) Design

2.1. Objectives

  • Define the digital framework for batch production records.
  • Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • Enable version control, audit trails, and electronic signatures.

2.2. Key Features

  • Hierarchical MBR Structure:
    • Header (Batch ID, Product, Version, Expiry)
    • Materials (Bill of Materials - BOM)
    • Equipment & Resources
    • Process Steps (Phases, Operations, Sub-Operations)
    • Quality Checks & In-Process Controls (IPC)
  • Dynamic Adjustments:
    • Conditional branching based on process parameters (e.g., if pH > X, then adjust).
    • Scalable for different batch sizes.
  • Compliance & Traceability:
    • Full audit trail of changes.
    • Electronic signatures (ESign) for approvals.

2.3. Data Model

Field Type Description
MBR_ID GUID Unique identifier
Version String Semantic versioning (v1.0.0)
Status Enum (Draft, Approved, Retired) Lifecycle state
Effective Date DateTime When MBR becomes active
BOM_Link Foreign Key Linked Bill of Materials

3. Recipe & Workflow Design

3.1. Recipe Types

  • Standard Recipe: Fixed steps for a product.
  • Flexible Recipe: Adjustable parameters (e.g., mixing time, temperature).
  • Parameterized Recipe: Uses formulas (e.g., scaling based on batch size).

3.2. Recipe Structure

  • Header: Product, Version, Validity Period.
  • Phases:
    • Pre-Weighing → Dispensing → Mixing → Filling → Packaging
  • Parameters:
    • Critical Process Parameters (CPPs)
    • Acceptable Ranges (Min/Max)
    • Default Values

3.3. Workflow Engine

  • State Machine: Defines transitions (e.g., Pending → In Progress → Completed).
  • Dependencies: Equipment availability, material readiness.
  • Exception Handling: Deviations trigger alerts or alternate paths.

4. Process Instructions & Operator Guidance

4.1. Instruction Types

  • Text-Based: SOPs, warnings.
  • Multimedia: Images, videos, PDFs.
  • Interactive:
    • Scan barcode to confirm material.
    • Enter manual readings (e.g., pH, temperature).

4.2. Execution Rules

  • Mandatory vs. Optional Steps: Some steps require sign-off before proceeding.
  • Conditional Instructions:
    • If Temperature > 30°C, show cooling instructions.
  • Real-Time Feedback:
    • Equipment integration (e.g., SCADA, PLC) auto-captures data.

4.3. UI/UX Considerations

  • Operator HMI: Touchscreen-friendly, minimal clicks.
  • Alerts: Color-coded (Red = Critical, Yellow = Warning).

5. Electronic Batch Record (EBR) Execution

5.1. EBR Lifecycle

  1. Initiation: Batch created from MBR.
  2. Execution: Operators follow guided steps.
  3. Data Capture: Manual entries + automated (from PLCs, scales).
  4. Review: QA checks before release.
  5. Approval: Electronic signature by supervisor.

5.2. Key Requirements

  • Data Integrity:
    • No backdating, all changes logged.
  • Deviations Management:
    • Record out-of-spec (OOS) events.
    • Attach investigations (CAPA).
  • Reporting:
    • Batch Summary Report (PDF/Excel).
    • Trend analysis (e.g., yield, cycle time).

5.3. Integration

  • ERP (SAP/Oracle): Material consumption, batch status.
  • LIMS: QC test results.
  • SCADA/PLC: Real-time process data.

6. Compliance & Validation

  • 21 CFR Part 11: Audit trails, eSignatures.
  • GAMP 5: Category 4/5 software validation.
  • Data Backup & Recovery: Daily backups, disaster recovery.

7. Conclusion

This MES design ensures paperless batch execution, real-time process control, and regulatory compliance while leveraging best practices from top MES vendors.

Next Steps:

  • Prototype MBR & Recipe in a sandbox.
  • Conduct UAT with operators.
  • Validate against GxP requirements.

Approval

Role Name Signature Date
MES Architect [Name] [E-Sign] [DD/MM/YYYY]
QA Manager [Name] [E-Sign] [DD/MM/YYYY]

Version Control

Version Date Changes Author
1.0.0 [DD/MM/YYYY] Initial Draft [Name]

This document provides a comprehensive, vendor-agnostic MES specification focusing on MBR, Recipe, Process Instructions, and EBR execution. Adjust based on specific industry needs (Pharma, Food, Chemicals).