Ajinomoto Co JA – 819
The scope of the audit was to evaluate the effectiveness of the quality management system of pharmaceutical manufacturing, packaging, distribution and support functions for the following material:
L-Proline and Repacks
Basic Chemicals/Raw Materials:
Further amino acids (L-Cysteine)
Audit criteria used for the audit consisted of the RX 360 Audit Standard for Active Pharmaceutical Ingredients and API Intermediates v.1.0. Document Number: 2460627 and the Supply Chain Security Checklist v.2.0 Document Number: 2790748.