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SSA1 (Health)PharmaceuticalActive

NOM-164-SSA1-2015

Good manufacturing practices for pharmaceutical ingredients

Complements NOM-059-SSA1 establishing specific GMP requirements for active pharmaceutical ingredients (APIs). Applies to manufacturing, import and distribution of active ingredients used in medicines.

Last updated: 2023

Affected products

Active pharmaceutical ingredientsImported APIsPharmaceutical raw materialsPharmaceutical excipients

Compliance requirements

  • Quality management system for APIs
  • Raw materials and supplier control
  • Synthesis process validation
  • Impurity and cross-contamination control
  • Complete lot traceability

Related tariff codes

These tariff codes may be subject to this NOM. Check the specific code to confirm.

2941.90.012942.00.013003.10.01

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