WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1. List of available International Chemical Reference Substances1
View the documentAnnex 2. List of available International Infrared Reference Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Close this folderAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
View the document1. General considerations
View the document2. Glossary
View the document3. Self-inspection and quality audits
Open this folder and view contents4. Equipment
Open this folder and view contents5. Materials
Open this folder and view contents6. Documentation
Open this folder and view contents7. Good practices in production and quality control
Open this folder and view contentsAnnex 6. Guidelines for inspection of drug distribution channels
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Open this folder and view contentsAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 

2. Glossary

The definitions given below apply to the terms used in these guidelines. They may have different meanings in other contexts.

commingling
The blending of carry-over material from one grade of an excipient with another, usually due to a continuous process.

drug master file1
Detailed information concerning a specific facility, process or product submitted to the drug regulatory authority, intended for incorporation into the application for marketing authorization.

1 This term appears to be specific to United States regulations.

 

model product
A product which simulates a group of similar products.

mother liquor
A concentrated solution from which the product is obtained by evaporation, freezing, and/or crystallization.

pharmaceutical excipients
Substances, other than the active ingredient, which have been appropriately evaluated for safety and are included in a drug delivery system to:

- aid in the processing of the drug delivery system during its manufacture;

 

- protect, support or enhance stability, bioavailability, or patient acceptability:

- assist in product identification; or

- enhance any other attribute of the overall safety and effectiveness of the drug during storage or use.

 

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