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
Close this folderAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
View the documentIntroduction
Close this folderPart A. Primary chemical reference substances
View the document1. Assessment of need for the establishment of chemical reference substances
View the document2. Obtaining source material
Open this folder and view contents3. Evaluation of chemical reference substances
Open this folder and view contents4. Chemical and physical methods used in evaluating chemical reference substances
View the document5. Assignment of content
Close this folder6. Handling and distribution of chemical reference substances
View the document6.1 Packaging operations
View the document6.2 Storage
View the document6.3 Stability
View the document6.4 Information to be supplied with chemical reference substances
View the document6.5 Distribution and supply
View the document6.6 Period of use
View the documentPart B. Secondary chemical reference substances
View the documentReferences
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
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
 
6.1 Packaging operations

Current GMP requirements (5) should be observed. The various stages in packaging chemical reference substances should be clearly defined and controlled, to avoid contamination of the sample, mislabelling of containers, or any other event which might result in mishandling or mismanagement.

Containers for chemical reference substances should protect their contents from moisture, light and oxygen and must be tested for moisture permeability. Additional measures may be necessary to ensure long-term integrity and stability. The best containers for chemical reference substances from the point of view of stability are sealed glass ampoules, but these have certain disadvantages. There is the risk of contaminating the substance with glass particles when the ampoules are opened, and reclosure is difficult. Sealable glass ampoules are therefore principally used for substances that must be kept in an oxygen-free atmosphere. Certain other substances may require even more elaborate protection. Most chemical reference substances, however, are conveniently supplied in reclosable containers which should be uniform in type and size to facilitate distribution. The lack of permeability to moisture is an important factor in determining the suitability of container closure systems.

Before undertaking any packaging operations, the health hazards of the item to be packaged should be assessed through information sources, e.g. the Material Safety Data Sheet. Appropriate precautions should be taken to protect the person handling the chemical reference substance.

The packaging of a batch of a chemical reference substance into containers is a small-scale operation for which suitable equipment is not always available to the manufacturer of the material. Therefore, the packaging of chemical reference substances is usually undertaken by the responsible issuing body. Screw-type feeders have been constructed, but generally the packaging of chemical reference substances is carried out manually. Substances which are expensive or only available in very small quantities may have to be divided between containers in solution and then lyophilized, or evaporated to dryness.

Some chemical reference substances must be packaged under an inert gas or in conditions of controlled humidity. Therefore, the use of a glove-box or an air-tight cabinet is necessary.

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