Audit Report

Merck S.L.U JA – 798

Audit #: JA - 798
Region: Spain
Material: API/ExcipientsBasic Chemicals/Raw Materials
Company: Merck S.L.U
Location: 08100 Mollet del Valles (Barcelona)
Date: 6-7 March 2017

This Rx-360 Audit Report contains the following scope:

The scope of the audit includes the sterilization, testing, packaging and distribution of
Basic Chemicals/Raw Materials:
Sodium edetat dihydrate
API:
Meglumine
Excipient:
Tris(Hydroxymethyl)aminomethane (TROMETAMOL) high purity suitable for
biopharmaceutical production EMPROVE® bio Ph
Eur,BP,JPC,USP,ACS. (art. 1.08307)
Tris(hydroxymethyl)aminomethane (Trometamol) suitable for use as excipient EMPROVE®
exp Ph Eur,BP,JP,USP (art. 1.08386)
Titriplex® III (Ethylene diaminetetraacetic Acid (EDTA), Disodium Salt, Dihydrate) suitable
for use as excipient EMPROVE® exp Ph
Eur, BP, JP, USP. (1.08421)
TITRIPLEX III (Ethylene diaminetetraacetic Acid (EDTA), Disodium Salt, Dihydrate)
suitable for the biopharmaceutical production.
EMPROVE® bio Ph Eur, BP, JP, USP, ACS. (1.37004)
Active cosmetic ingredients also treated as atypical APIs:
Eusolex® OCR (Octocrylene)
Eusolex® 9020 (Butyl Methoxydibenzoylmethane)
The audit was based on Rx-360 Consortium guidelines for Basic Chemicals/Raw
Materials and the Rx-360 Supply Chain Security Checklist 2.0.