Document Name: Rx-360 Audit Guide for Basic
Chemicals and Raw Materials_v0.1
Document Number:  2460023
documented evidenceRevision Date:  New
Effective Date:  8 September 2010
RX-360 AUDIT GUIDE FOR BASIC CHEMICALS AND RAW
MATERIALS
Approved by: signatures and date on original copies maintained within Rx-360 Approved by: signatures and date on original copies maintained within Rx-360
INTRODUCTION
The Rx-360 audit guide for basic chemicals and raw materials are based on the IPEC/PQG Good Manufacturing Practices Audit Guide for Pharmaceutical Excipients (2007).
SCOPE
This document applies to all basic chemicals and raw materials used in pharmaceutical manufacture.  Therefore, the scope may include but is not limited to processing aids, disinfectants, detergents, lubricants, gases, solvents, basic chemicals, and raw materials used
in the manufacture of API intermediates.  This document does not include details of sterility assurance and is therefore only partially applicable to sterile materials/components. GLOSSARY
The terms used within this document are defined in; ISO 9001:2008, Quality management systems-Requirements and Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients 2006.
Quality standards in the context of this guide do not necessarily mean current Good Manufacturing Practices (cGMPS).  Audited manufacturers within the scope of this guide may adhere to quality standards other than cGMP (e.g., ISO) so long as the there are sufficient controls in place to ensure the quality, purity, safety, and suitability for use of the materials produced.
Basic chemicals include processing aids, including materials driven off during manufacture,
< water, solvents; materials used for safety reasons, e.g. headspace gases; materials used in manufacturing area, but not in direct contact with product, e.g. disinfectants, detergents, lubricants.  Raw materials include starting materials, e.g. chemicals used to manufacture API intermediates, and materials used in the transfer between processing steps, e.g. tubing, filters.    AUDIT GUIDE
The quality audit guide follows, which may be used as a tool to perform audits.
NOTE – This guide is applicable to a broad spectrum of materials/grades ranging from technical to compendia grade and from basic chemicals to raw materials used as starting materials.  As such, not all line items apply to all materials.  Record objective evidence and outcomes as appropriate.  It is up to the receiving company to determine if a given manufacturer and material is suitable for its intended use.
NOTE -- This guide may be used in conjunction with the Rx-360 Supply Chain Security Checklist
NOTE-an acknowledgement will be given to IPEC/PQG and formal permission is being sought
to obtain permission to use the IPEC/PQG audit guide and guideline as a basis for this audit guide.

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