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Module 5 of 5 · ISO 22716 · Block 5

Documentation and traceability

ISO 22716 requires solid documentation that can reconstruct the complete history of every batch manufactured.

Content reviewed on

Document control

Version management for procedures, specifications, and records, with access and change control.

Batch traceability

The ability to reconstruct a batch's complete history: raw materials, process, controls, and distribution.

Internal audit

Periodic verification of good manufacturing practice compliance through internal audits.

What an auditor usually asks for

  • Document control system in place
  • Full traceability available for every batch
  • Active internal audit program
  • Audit findings logged along with their closure

How to cover this block in Kimobox

  1. 1Manage all GMP documents with version control in Kimobox.
  2. 2Look up the full traceability of any batch from a single record.
  3. 3Plan and log internal audits from the same system.

Full batch traceability is one click away, with nothing rebuilt by hand for every audit.

See Kimobox's document control

Where each figure comes from

References to the official text in force. If a standard is revised, this page is updated and the review date says so.

  1. ISO 22716:2007 — Cosmetics. Good Manufacturing Practices ISO · 2007 ed.
  2. Regulation (EC) No 1223/2009 on cosmetic products EUR-Lex · 30 November 2009