[
[01]

The Joint IPEC – PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients (2006)

[02]

ICH Q7 GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS (2000)

[03]

The IPEC Good Distribution Practices Guide for Pharmaceutical Excipients (2006)

[04]

IPEC Qualification of Excipients for Use in Pharmaceuticals (2008)

[05]

IPEC-Americas Significant Change Guide For Bulk Pharmaceutical Excipients (2005)

[06]

IPEC Standardized Excipient Information Protocol User Guide (2005)

[07]

The International Pharmaceutical Excipients Council of the Americas Excipient Master File Guide (2004)

[08]

IPEC-Americas® Certificate of Analysis Guide for Bulk Pharmaceutical Excipients (2000)

[09]

ICH Q8 PHARMACEUTICAL DEVELOPMENT (2005)

[10]

ICH Q9 Quality Risk Management (2005)

[11]

ICH Q10 Pharmaceutical Quality System (2008)

[12]

ICH Q6A: Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products : Chemical Substances (1999)

[13]

ICH Q1A(R2): Stability Testing of New Drug Substances and Products (Second Revision) (2003)

[14]

ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology (2005)

[15]

ICH Q3A(R2): Impurities in New Drug Substances (Revised Guideline) (2006)

[16]

ICH Q3C(R3): Impurities: Guideline for Residual Solvents (1997)

[17]

Good distribution practices for pharmaceutical products, WHO Technical Report Series, No. 937, 2006

[18]

Good Trade and Distribution Practices for Pharmaceutical Starting Materials, WHO Technical Report Series, No. 917, 2003

[19]

Guide to Good Storage Practices for Pharmaceuticals, WHO Technical Report Series, No. 908, 2003

[20]

Good Manufacturing Practices for pharmaceutical products: main principles, WHO Technical Report Series, No. 908, 2003

[21]

General guidelines for the establishment, maintenance and distribution of chemical reference substances, World Health Organization, WHO Technical Report Series, No. 943, 2007

[22]

Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Pharmaceutical Excipients, WHO Technical Report Series, No. 885, 1999

[23]

Supplementary guidelines on good manufacturing practices: validation, WHO Technical Report Series, No. 937, 2006

[24]

Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability, WHO Technical Report Series, No. 937, 2006

[25]

A model quality assurance system for procurement agencies (Recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products), WHO Technical Report Series, No. 937, 2006

[26]

WHO guidelines for sampling of pharmaceutical products and related materials, World Health Organization, WHO Technical Report Series, No. 929, 2004

[27]

American Chemical Society. "CAS Registry and CASRNs". Retrieved by Wikipedia 25 July 2009. http://en.wikipedia.org/wiki/CAS_registry_number

[28]

http://en.wikipedia.org/wiki/Common_Technical_Document

[29]

FDA's Jan 2011 Process validation Guidance document

[30]

ICH Q8 (R2) Pharmaceutical Development

[31]

ASQC definition