National Chemical Company

NCC was one of the first Irish Companies assessed to SQAS ESAD II including Sections F (Food, Pharma & Cosmetics) and G (Good Trade & Distribution Practice). NCC underwent this independent Assessment in October 2008 achieving an outstanding result of 93%. Detailed results are available on request.

ESAD, the European Single Assessment Document, was created to provide a voluntary assessment system to evaluate the quality, safety and environmental performance of Chemical Distributors in a uniform manner through single standardized assessments, carried out by independent assessors using a standard questionnaire. It is based on the Guiding Principles of Responsible Care®

For the benefit of suppliers and distributors ESAD has been upgraded to ESAD-II following addition of two new sections F and G and improvement of both the structure of the questionnaire and the guidelines. ESAD has also been fully integrated in the SQAS scheme and is therefore now often called SQAS Distributor. See http://www.sqas.org/ for further details.

Scope of Section F:

Section F provides appropriate handling advice to minimize the special risk in Food, Pharma and Cosmetic applications. It assesses specific quality measures in compliance with GMP/GTDP principles (“GMP/GTDP basics”) and involves the supply chain from original manufacturer´s warehouse downstream to final user. Section F does not cover full GMP/GTDP

G: GTDP (Good Trade and Distribution Practices)

Sub Section G assesses GTDP Compliance of pharmaceutical excipient distribution.

Excipients are substances other than the Active Pharmaceutical Ingredient which are included in a drug delivery system.

It requires a base Certification of a quality system in addition such items as

A Pest control programme, detailed requirements for premises, monitoring of storage conditions, segregation of rejected materials, checks of Certificates Of Analysis against specifications, a document control system, and release procedures.

Customers need to be informed about mixed lots and detailed complaint and recall procedures are needed. It also requires detailed procedures on non-conforming goods.