Audit Report

Ajinomoto Co JA – 819

Audit #: JA - 819
Region: United States
Material: API/Excipients
Company: Ajinomoto Co
Location: 4020 Ajinomoto Drive Raleigh, North Carolina 27610
Date: 1-2 November 2017

The scope of the audit was to evaluate the effectiveness of the quality management system of pharmaceutical manufacturing, packaging, distribution and support functions forĀ  the following material:

L-Arginine base

L-Arginine HCL

L-Methionine

L-Histidine

L-Proline and Repacks

L-Serine

N-Acetyl-Tryptophan

L-Glutamine

Basic Chemicals/Raw Materials:

Further amino acids (L-Cysteine)

GDP

 

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.