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Production (GMP) — Overview

This section covers everything that happens from the moment raw materials enter your process until the finished product is released. It is the largest section and the one most directly scrutinised during inspections.

What this section covers

  • Master Formula / Master Manufacturing Record — the controlled recipe
  • Batch Manufacturing Record (BMR) — recording every production event
  • Weighing and dispensing — controls for measuring raw materials
  • In-process controls — checks performed during manufacture
  • Line clearance — ensuring no carry-over between batches
  • Yield calculation and reconciliation
  • Packaging operations — filling, labelling, and sealing controls
  • Batch numbering system — how to assign and trace batch numbers
  • Process validation — proving your process reliably makes a good product
  • HACCP principles — for food-supplement operations
  • Handling of rejected or reworked material